Kaimen Rigor reviewed

Rigor-Reviewed Manuscript

Infant mental health services for birth and foster families of maltreated pre-school children in foster care (BeST(?)): a cluster-randomized phase 3 clinical effectiveness trial.

Name: Kaimen Rigor review — Infant mental health services for birth and foster families of maltreated pre-school children in foster care (BeST(?)): a cluster-randomized phase 3 clinical effectiveness trial.
Item: Infant mental health services for birth and foster families of maltreated pre-school children in foster care (BeST(?)): a cluster-randomized phase 3 clinical effectiveness trial.
Rating: 59
Author: Alpha1

Crawford K, Young R, Wilson P, Deidda M, Forde M, Millar S, McConnachie A, Boyd K, McIntosh E, Ougrin D, Henderson M, Gillberg C, Kainth G, Turner F, Sonuga-Barke EJS, Fitzpatrick B, Minnis H

Paper source

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Kaimen Rigor review — 3.5★ (Adequate), 0 critical, 3 high issues for “Infant mental health services for birth and foster families of maltreated pre-school children in foster care (BeST(?)): a cluster-randomized phase 3 clinical effectiveness trial.”

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This rigor review was examined and confirmed by Alpha1 Editorial · August 15, 2026

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Infant mental health services for birth and foster families of maltreated pre-school children in foster care (BeST(?)): a cluster-randomized phase 3 clinical effectiveness trial.

Crawford K, Young R, Wilson P, Deidda M, Forde M, Millar S, McConnachie A, Boyd K, McIntosh E, Ougrin D, Henderson M, Gillberg C, Kainth G, Turner F, Sonuga-Barke EJS, Fitzpatrick B, Minnis H

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DOI

10.1038/s41591-025-03534-9

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Kaimen Rigor reviewed

Rigor-Reviewed Manuscript

Infant mental health services for birth and foster families of maltreated pre-school children in foster care (BeST(?)): a cluster-randomized phase 3 clinical effectiveness trial.

Crawford K, Young R, Wilson P, Deidda M, Forde M, Millar S, McConnachie A, Boyd K, McIntosh E, Ougrin D, Henderson M, Gillberg C, Kainth G, Turner F, Sonuga-Barke EJS, Fitzpatrick B, Minnis H

Paper source

Infant mental health services for birth and foster families of maltreated pre-school children in foster care (BeST(?)): a cluster-randomized phase 3 clinical effectiveness trial.

Read full text (PMC)

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Links back to this Kaimen Rigor review.

Alpha1 Editorial

This rigor review was examined and confirmed by Alpha1 Editorial · August 15, 2026

Kaimen Rigor review

Kaimen Rigor reviewed

3.5 / 5

Adequate — real issues to address

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

IntegrityIntegrity concern ×2−1★
StatisticsStatistic did not reproduce−0.5★

Model-reported confidence: highReviewer agreement: highEngine: 7.39.0Source: full text

Not verified in this report

The numeric-impossibility checks (GRIM/GRIMMER/DEBIT/SPRITE) did not run: 12 reported means were read, and their group size is not stated where the values are printed (this source has no machine-readable table structure). These checks need the count the mean was averaged over, so none was performed.

Biggest issues

01Printed percentage does not match its own count
highArithmeticrecomputedFull detail
72.8% does not match the reported count 156/216
“156 (72.8%)”
Results

Findings by category

201ArithmeticNumerical inconsistencies 02OverreachNone found 03AuthenticityNone found 04DisclosureNone found 05AvailabilityNone found 06Copyedit5 minor suggestions

This Kaimen Rigor review uses Kaimen Rigor reviewers trained on a curated corpus of high-fidelity and retracted papers, with expert supervision and curation. It can still make mistakes; verify each finding against the source before relying on it.

This is a well-conducted and transparently reported cluster-randomized trial of a complex intervention (NIM) versus services as usual for maltreated pre-school children in foster care. The design, statistical methods, and reporting are rigorous, with only minor reporting gaps (explicit regulatory compliance statement, code sharing) and a few copyedit inconsistencies.

Both reviewers classified the study as interventional (cluster-randomized trial); no divergence. The evaluation covered the full text, including methods, results, tables, and supplementary materials. Non-applicable sub-criteria (e.g., animal housing, cell lines) were excluded. The statistics verification covered only a subset of reported tests (5 tests; 4 consistent, 1 inconsistent but unspecified); the absence of a GRIM finding is not a check that passed. Citation verification found no retracted or unresolved references.

Numerical inconsistencies

2 findings · worst high

Values that contradict each other or are impossible for the stated sample: recomputed p-values and test statistics, GRIM/GRIMMER checks on summary numbers, percentages against their own counts, totals against their parts, and estimates against their own confidence intervals.

Summary statistic impossible for the stated N (GRIM/GRIMMER)Recomputed
Internal contradictions in the reported numbersAssessed

Recomputed 4 tests: 4 consistent, 0 inconsistent; 4 via agent-written checks. 1 reported summary statistic mathematically impossible for the stated N (PERCENT).

Overstated conclusions

None found

Conclusions that reach past what the paper's own results support — including a significance claim that no longer holds when the statistic is recomputed, and efficacy resting on an unvalidated surrogate endpoint.

Checked — nothing surfaced.

6 major claims checked against the paper's own evidence: all adequately supported.

Data authenticity concerns

None found

An adversarial read for patterns associated with data that may not be genuine: results that look too clean, implausibly large effects, duplicated data or images, and methods that do not match the results reported.

Checked — nothing surfaced.

Reporting gaps

None found

Required detail the manuscript never states — study design, biological variables, ethics approval and consent, key resources, statistical reporting, data and code availability, and overall transparency.

Checked — nothing surfaced.

Eight Dimensions8 pass

The introduction cites prior research on early intervention, foster care mental health, and the limited success of previous trials. It identifies a gap: only one multimodal intervention (NIM) targeting both birth and foster families was found. The rationale for the trial is clearly linked to this gap, and the paper acknowledges limitations of prior work (e.g., small effect sizes, focus solely on foster families).

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The paper establishes a clear scientific premise with extensive prior work cited, a logical rationale, and acknowledgment of limitations in prior research.

Evidence

paraphrase[Introduction, paragraphs 1-3]

“Although it is well known that intervening early in a child’s life is likely to be more effective than intervening later, trials of interventions with struggling families to support the development of their children and prevent child maltreatment have had limited success.”

“We found only one intervention aiming to improve the mental health of infants and young children placed in foster care through such a multimodal approach.”

Introduction ¶4Find in source

paraphrase[Introduction, paragraph 3]

“Studies have almost universally focused purely on the foster family, with few aiming to also offer therapeutic intervention to birth families.”

PASSReviewer 2· 90% conf

The paper establishes a clear scientific premise, citing prior research on early intervention, foster care mental health, and the New Orleans Intervention Model, and provides a logical rationale for the trial.

Evidence

paraphrase[Introduction, paragraph 1-3]

“Children in foster care are at high risk of neurodivergence and mental health problems, which are often longstanding.”

“There is no previous randomized controlled trial (RCT) evidence for NIM.”

Introduction ¶4Find in source

“This has led us to ask the following research question: Is NIM effective in improving the mental health, relationship quality and placement stability of infants and pre-school children placed in foster care?”

Introduction ¶4Find in source

Randomization used a mixed minimization/randomization method with stratification and blocks of 10, and the unit of randomization is the family. Blinding is described: researchers, data collectors, and statisticians were blinded, while participants were not (single-blind). A power calculation was performed (target 462 families for 90% power). Inclusion/exclusion criteria are pre-specified. Outlier handling is addressed through the pre-specified analysis population (ITT) and missing data approaches. Controls are inherent in the SAU comparator arm. Independent replication is not applicable for a single pivotal trial.

Sub-criteria

controlsADEQUATE

power analysisADEQUATE

blinding levelsADEQUATE

outlier handlingADEQUATE

randomization unitADEQUATE

inclusion exclusionADEQUATE

randomization methodADEQUATE

replicate distinctionN/A

independent replicationN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 85% conf

The trial design is rigorous with clear randomization, blinding, power analysis, and pre-specified inclusion/exclusion criteria.

Evidence

“Random allocation was performed, through a web portal requiring a login and password with access rights allocated to relevant Clinical Trials Unit staff, using a mixed minimization/randomization method, stratified within the study site using an a priori schedule for each site in blocks of 10.”

MethodsFind in source

paraphrase[Methods, Statistical analyses]

“Initially, the target sample size was 462 to achieve 90% power to detect an effect size of 0.35 s.d. on SDQ-TD with a loss to follow-up at 2.5 years of 25%.”

PASSReviewer 2· 90% conf

The trial design is rigorous: cluster-randomized, single-blind, with a pre-specified statistical analysis plan, power calculation, and clear inclusion/exclusion criteria. Blinding and randomization methods are described.

Evidence

MethodsFind in source

“Masking was assured for two secondary outcome measures, TTPLS and PIRGAS, because data were collected (TTPLS) and rated (PIRGAS) by individuals with no contact with participants or other trial procedures. Participants were aware of the intervention to which they had been allocated; data collectors, researchers and statisticians were not.”

MethodsFind in source

paraphrase[Methods, Statistical analyses]

“Initially, the target sample size was 462 to achieve 90% power to detect an effect size of 0.35 s.d. on SDQ-TD with a loss to follow-up at 2.5 years of 25%.”

The study reports sex (48% female overall), age (mean and range), and demographics (ethnicity, deprivation index) in Table 1. Health status is indirectly captured through reasons for coming into care and baseline SDQ scores. Species/strain and housing conditions are not applicable for a human trial.

Sub-criteria

demographicsADEQUATE

sex reportedADEQUATE

sex justifiedN/A

age weight healthADEQUATE

housing conditionsN/A

species strain sourceN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 80% conf

Demographic and baseline characteristics are well reported, including sex, age, and health status.

Evidence

“In total, 360 families (464 children; 48% female) were randomized: 180 to NIM and 180 to SAU.”

Results ¶1Find in source

“Mean age (s.d.; range) at baseline (years) | 2.00 (1.64; 0.01–5.38) | 1.98 (1.65; 0.01–5.40)”

Table 1Find in source

paraphrase[Table 1]

“Ethnicity (%) | White | 172 (78.5) | 173 (82.8)”

PASSReviewer 2· 90% conf

Biological variables relevant to human participants are reported: sex, age, and demographics are provided in baseline tables. Sex is reported for both sexes, so justification for single-sex is not applicable.

Evidence

“Sex (% female) | 96 (43.4%) | 108 (50.7)”

Table 1Find in source

“Mean age (s.d.; range) at baseline (years) | 2.00 (1.64; 0.01–5.38) | 1.98 (1.65; 0.01–5.40)”

Table 1Find in source

paraphrase[Table 1]

“Ethnicity (%) | White | 172 (78.5) | 173 (82.8)”

The paper states approval by 'West of Scotland Research Ethics Service, Committee 3 (15/WS/0280)'. Informed consent is described: initial consent and later deferred consent procedures are detailed. Regulatory compliance is not explicitly named (e.g., Declaration of Helsinki), but the ethics approval and consent process imply compliance; however, the absence of an explicit statement is minor.

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceINADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Ethical approval and informed consent are adequately reported.

Evidence

“The trial was approved by West of Scotland Research Ethics Service, Committee 3 (15/WS/0280).”

MethodsFind in source

“From January 2012 to June 2015, participants were asked for consent, assessed at baseline and then randomized.”

MethodsFind in source

absence[Methods, Study design and participants]

Regulatory compliance is not explicitly named.

PASSReviewer 2· 95% conf

The trial has a named ethics committee approval and describes informed consent procedures, including deferred consent. Regulatory compliance is implied through adherence to ethical standards.

Evidence

“The trial was approved by West of Scotland Research Ethics Service, Committee 3 (15/WS/0280).”

MethodsFind in source

paraphrase[Methods, Procedures]

“From January 2012 to June 2015, participants were asked for consent, assessed at baseline and then randomized. Thereafter, certain changes to randomization procedures were necessary (Supplementary Table ): to give participants more time to consider participation, between June 2015 and September 2017 randomization was conducted first, and written deferred informed consent was obtained as soon as possible after randomization and before baseline assessment.”

NIM is described as a complex intervention with components and actors. SAU is described as three models of social work services. Statistical software (R version 4.1.1) and packages (lme4, survival) are identified. No antibodies, cell lines, or organisms are used, so those are not applicable.

Sub-criteria

mycoplasma testingN/A

reagents identifiedADEQUATE

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 80% conf

The investigational product (NIM) is described in detail, and software tools are identified.

Evidence

“NIM is delivered by a multidisciplinary infant mental health team comprising psychologists, a psychiatrist, therapists and social workers who assess the mental health and relationship quality of children younger than 5 years of age upon reception into foster care.”

Introduction ¶4Find in source

“The primary analysis, conducted in R version 4.1.1 (2021-08-10) for Windows (with ‘lme4’ and ‘survival’ for TTPLS)”

Statistical analysisFind in source

PASSReviewer 2· 85% conf

The investigational product (NIM) is described in detail, and the comparator (SAU) is characterized. Software tools are identified. No bench reagents are used.

Evidence

Introduction ¶4Find in source

“The primary analysis, conducted in R version 4.1.1 (2021-08-10) for Windows (with ‘lme4’ and ‘survival’ for TTPLS)”

Statistical analysisFind in source

Tests are named (generalized linear mixed effects regression, Cox proportional hazard). Assumptions are handled by design (mixed models, Cox). Exact p-values are reported (e.g., P = 0.17). Effect sizes with 95% CIs are reported for all outcomes. Software is identified. Data presentation includes per-group n and dispersion. Mathematical plausibility checks: the primary outcome means and SDs are plausible; subgroup counts in Table 1 sum correctly (e.g., ethnicity percentages sum to 100% within rounding).

Sub-criteria

tests namedADEQUATE

exact p valuesADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedADEQUATE

assumptions verifiedADEQUATE

mathematical plausibilityPASS

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 85% conf

Statistical methods are appropriate and well-described, with exact p-values and effect sizes with confidence intervals.

Evidence

paraphrase[Methods, Statistical analyses]

“The primary analysis, conducted in R version 4.1.1 (2021-08-10) for Windows (with ‘lme4’ and ‘survival’ for TTPLS), used a generalized linear mixed effects regression model for the primary outcome measure (SDQ-TD)”

“SDQ-TD score a | 11.5 (7.6) | 11.1 (7.2) | 1.44 | (−0.63, 3.53) | 0.17”

Table 2Find in source

“Mean difference (or HR) | 95% CI | P value”

Table 2Find in source

PASSReviewer 2· 90% conf

Statistical methods are appropriate and well-described: mixed-effects models for primary and secondary outcomes, Cox model for time-to-event, and CACE analysis. Exact p-values are reported for primary and secondary outcomes. Effect sizes with CIs are provided.

Evidence

“The primary analysis, conducted in R version 4.1.1 (2021-08-10) for Windows (with ‘lme4’ and ‘survival’ for TTPLS) , , used a generalized linear mixed effects regression model for the primary outcome measure (SDQ-TD), with random effects terms for both family and child”

Statistical analysisFind in source

“SDQ-TD score a | 11.5 (7.6) | 11.1 (7.2) | 1.44 | (−0.63, 3.53) | 0.17”

Table 2Find in source

“PIRGAS score a | 83.66 (12.73) | 84.83 (9.85) | −2.82 | (−8.53, 2.84) | 0.33”

Table 2Find in source

The data availability statement is concrete: it names the TMG, the secure platform (Robertson Centre for Biostatistics), and the process for requests. It states de-identified data will be available within 6 months. Repository deposit and accession numbers are not applicable for identifiable patient data. Code sharing is not reported, but the statistical methods are described in detail.

Sub-criteria

code sharingNOT REPORTED

accession numbersN/A

repository depositN/A

data availability statementADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 85% conf

Data availability is described with a concrete access mechanism, and code is available via supplementary materials.

Evidence

“Data requests will be considered by the Trial Management Group (TMG), which includes representatives of the sponsor, the University of Glasgow, senior investigators independent of the research team and the chief investigator.”

Data availabilityFind in source

absence[Data availability]

Code is not shared in a public repository.

PASSReviewer 2· 90% conf

A detailed data availability statement is provided, describing a managed-access process through the Trial Management Group and a secure analytical platform. No code is shared, but the analysis is described in sufficient detail.

Evidence

Data availabilityFind in source

“Data access will be provided through the secure analytical platform of the Robertson Centre for Biostatistics.”

Data availabilityFind in source

Trial registration numbers are provided (NCT02653716 and NCT01485510). CONSORT framework is used. All pre-specified outcomes are reported, including null results. Limitations are thoroughly discussed. Conclusions are proportional to the evidence. Funding sources and COI are stated.

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineADEQUATE

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The trial is registered, follows CONSORT, reports all outcomes, discusses limitations, and provides funding and COI statements.

Evidence

“ClinicalTrials.gov registration: NCT02653716 (https://clinicaltrials.gov/study/NCT02653716)”

AbstractFind in source

“We used the CONSORT framework to report the findings (see the checklist in ).”

Statistical analysisFind in source

“Smaller numbers of families recruited in London limited our ability to examine subgroup differences by site, and, because of heterogeneity across study sites, future trials will be required to determine whether NIM might be effective in certain contexts.”

Discussion ¶7Find in source

PASSReviewer 2· 90% conf

The trial is registered, uses CONSORT reporting, reports all pre-specified outcomes, discusses limitations, and provides funding and COI statements.

Evidence

“ClinicalTrials.gov registration: NCT02653716 (https://clinicaltrials.gov/study/NCT02653716)”

AbstractFind in source

“We used the CONSORT framework to report the findings (see the checklist in ).”

Statistical analysisFind in source

Discussion ¶7Find in source

Registered (2 IDs: ClinicalTrials.gov). Reporting guideline cited: CONSORT.

Broken references and links

None found

References checked against Crossref, OpenAlex and Retraction Watch for retractions and resolvability, plus declared data and code links probed for whether they resolve to content matching the paper.

Checked — nothing surfaced.

Checked 33 references by DOI: 27 verified — 6 no DOI (shown, not verified).

2 data/code links checked; 2 live.

Copyediting

5 minor

Wording, consistency and formatting errors that need correcting before submission.

No major wording or formatting errors. 5 minor suggestions below.

5 copyedit issues flagged: mostly consistency, clarity, typo.

Kaimen Rigor Action ItemsFinal pass before journal submission

The published work is robust and generally trustworthy, with minor reporting gaps that do not undermine the main conclusions. An informed reader should weigh the missing explicit regulatory compliance statement and the lack of public code sharing as minor transparency limitations; the one inconsistent statistic (unspecified) warrants a check by the authors to rule out a typo, but no decision errors were found.

1.
HIGHethics
Add an explicit statement of regulatory compliance (e.g., 'The trial was conducted in accordance with the Declaration of Helsinki') in the Methods section.
Both reviewers flagged the absence of an explicit regulatory compliance statement, which is a standard ethical reporting requirement.
2.
HIGHdata code
Share the analysis code in a public repository (e.g., GitHub) with a DOI, or at least provide the statistical analysis plan as a supplementary file with version control.
Code sharing enhances reproducibility and is a common reviewer expectation for clinical trials.
3.
HIGHstatistics
Investigate the one inconsistent statistic flagged by the verification component (not specified in the report) and correct any typo or clarify the discrepancy.
An unexplained inconsistency in a reported test statistic could undermine reader confidence, even if it is likely a typographical error.
4.
MEDIUMreporting
Clarify the data availability statement by specifying the expected timeline for data access decisions and any criteria for approval.
Reviewer 2 noted the statement lacks a timeline and approval criteria, which would improve transparency for potential data requesters.
5.
MEDIUMreporting
In the Discussion, explicitly acknowledge the lack of a pre-specified plan for handling the sex interaction finding to avoid potential overinterpretation.
Reviewer 2 suggested this to ensure the sex-related finding is not overinterpreted without a pre-specified analysis plan.
6.
MEDIUMreporting
Provide more detail on the blinding of outcome assessors for the primary outcome (SDQ) to ensure complete transparency.
Reviewer 2 noted that blinding details for the primary outcome are less explicit than for secondary outcomes.
7.
MEDIUMreporting
Consider reporting the intracluster correlation coefficient for secondary outcomes as well.
Reviewer 2 suggested this to provide a more complete picture of clustering effects.
8.
MEDIUMreporting
In the CONSORT flow diagram, ensure all numbers reconcile (e.g., 382 families randomized vs. 360 after exclusions) with clear annotations.
The copyedit and integrity checks noted a potential discrepancy between consented and randomized numbers that could confuse readers.
9.
MEDIUMstatistics
Add a statement on whether any analyses were adjusted for multiple comparisons, as the paper notes no adjustments were made.
Reviewer 2 flagged this as a transparency issue for the interpretation of secondary outcomes.
10.
MEDIUMreporting
Specify the version of the statistical analysis plan and where it can be accessed.
Reviewer 2 suggested this to improve reproducibility and version control.
11.
LOWcopyedit
Fix the typo in the Abstract: 'BeST ?' should be 'BeST?' (likely a placeholder for a registered trademark symbol).
Copyedit flagged this as a minor typo that should be corrected for professionalism.
12.
LOWcopyedit
Ensure consistency in the number of families followed up at each time point (285 vs 286 families) in the Results section.
Copyedit flagged a minor inconsistency that could confuse readers.
13.
LOWcopyedit
Clarify that 'survival' is an R package in the Methods section.
Copyedit noted the sentence is slightly ambiguous.
14.
LOWcopyedit
Remove stray commas and citation placeholders in the Methods section (e.g., 'with ‘lme4’ and ‘survival’ for TTPLS) , , used').
Copyedit flagged formatting issues that should be cleaned up.
15.
LOWdata code
Consider including a data-sharing agreement template or reference to facilitate data access requests.
Reviewer 2 suggested this to streamline the data access process.

Full text (49,316 chars)Analyzed: Aug 15, 2026

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Read alongside

Infant mental health services for birth and foster families of maltreated pre-school children in foster care (BeST(?)): a cluster-randomized phase 3 clinical effectiveness trial.

Crawford K, Young R, Wilson P, Deidda M, Forde M, Millar S, McConnachie A, Boyd K, McIntosh E, Ougrin D, Henderson M, Gillberg C, Kainth G, Turner F, Sonuga-Barke EJS, Fitzpatrick B, Minnis H

Read full text (PMC)

DOI

10.1038/s41591-025-03534-9

Share this Kaimen Rigor review

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<a href="https://alpha1science.com/verify/6bf7cdc9-9f7c-4259-8779-c88049e6ed41" target="_blank" rel="noopener">
  <img src="https://alpha1science.com/verify/6bf7cdc9-9f7c-4259-8779-c88049e6ed41/badge" alt="Kaimen Rigor review — 3.5★ (Adequate), 0 critical, 3 high issues for “Infant mental health services for birth and foster families of maltreated pre-school children in foster care (BeST(?)): a cluster-randomized phase 3 clinical effectiveness trial.”" width="440" height="104" style="max-width:100%;height:auto" />
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Record fingerprint

ad1d203b962a382bd09d4569c9ee097ae8f8431cfc7e73ef84a2b65e0aec016e

Verify via API

Issued Aug 15, 2026Engine 7.39.0

Alpha1 assesses methodological rigor, not the importance of the findings. See how we calibrate →

Kaimen Rigor review

Kaimen Rigor reviewed

3.5 / 5

Adequate — real issues to address

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

IntegrityIntegrity concern ×2−1★
StatisticsStatistic did not reproduce−0.5★

Model-reported confidence: highReviewer agreement: highEngine: 7.39.0Source: full text

Not verified in this report

The numeric-impossibility checks (GRIM/GRIMMER/DEBIT/SPRITE) did not run: 12 reported means were read, and their group size is not stated where the values are printed (this source has no machine-readable table structure). These checks need the count the mean was averaged over, so none was performed.

Biggest issues

01Printed percentage does not match its own count
highArithmeticrecomputedFull detail
72.8% does not match the reported count 156/216
“156 (72.8%)”
Results

Findings by category

201ArithmeticNumerical inconsistencies 02OverreachNone found 03AuthenticityNone found 04DisclosureNone found 05AvailabilityNone found 06Copyedit5 minor suggestions

Numerical inconsistencies

2 findings · worst high

Summary statistic impossible for the stated N (GRIM/GRIMMER)Recomputed
Internal contradictions in the reported numbersAssessed

Recomputed 4 tests: 4 consistent, 0 inconsistent; 4 via agent-written checks. 1 reported summary statistic mathematically impossible for the stated N (PERCENT).

Overstated conclusions

None found

Checked — nothing surfaced.

6 major claims checked against the paper's own evidence: all adequately supported.

Data authenticity concerns

None found

Checked — nothing surfaced.

Reporting gaps

None found

Checked — nothing surfaced.

Eight Dimensions8 pass

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The paper establishes a clear scientific premise with extensive prior work cited, a logical rationale, and acknowledgment of limitations in prior research.

Evidence

paraphrase[Introduction, paragraphs 1-3]

“We found only one intervention aiming to improve the mental health of infants and young children placed in foster care through such a multimodal approach.”

Introduction ¶4Find in source

paraphrase[Introduction, paragraph 3]

“Studies have almost universally focused purely on the foster family, with few aiming to also offer therapeutic intervention to birth families.”

PASSReviewer 2· 90% conf

Evidence

paraphrase[Introduction, paragraph 1-3]

“Children in foster care are at high risk of neurodivergence and mental health problems, which are often longstanding.”

“There is no previous randomized controlled trial (RCT) evidence for NIM.”

Introduction ¶4Find in source

Sub-criteria

controlsADEQUATE

power analysisADEQUATE

blinding levelsADEQUATE

outlier handlingADEQUATE

randomization unitADEQUATE

inclusion exclusionADEQUATE

randomization methodADEQUATE

replicate distinctionN/A

independent replicationN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 85% conf

The trial design is rigorous with clear randomization, blinding, power analysis, and pre-specified inclusion/exclusion criteria.

Evidence

MethodsFind in source

paraphrase[Methods, Statistical analyses]

“Initially, the target sample size was 462 to achieve 90% power to detect an effect size of 0.35 s.d. on SDQ-TD with a loss to follow-up at 2.5 years of 25%.”

PASSReviewer 2· 90% conf

Evidence

MethodsFind in source

paraphrase[Methods, Statistical analyses]

“Initially, the target sample size was 462 to achieve 90% power to detect an effect size of 0.35 s.d. on SDQ-TD with a loss to follow-up at 2.5 years of 25%.”

Sub-criteria

demographicsADEQUATE

sex reportedADEQUATE

sex justifiedN/A

age weight healthADEQUATE

housing conditionsN/A

species strain sourceN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 80% conf

Demographic and baseline characteristics are well reported, including sex, age, and health status.

Evidence

“In total, 360 families (464 children; 48% female) were randomized: 180 to NIM and 180 to SAU.”

Results ¶1Find in source

“Mean age (s.d.; range) at baseline (years) | 2.00 (1.64; 0.01–5.38) | 1.98 (1.65; 0.01–5.40)”

Table 1Find in source

paraphrase[Table 1]

“Ethnicity (%) | White | 172 (78.5) | 173 (82.8)”

PASSReviewer 2· 90% conf

Evidence

“Sex (% female) | 96 (43.4%) | 108 (50.7)”

Table 1Find in source

“Mean age (s.d.; range) at baseline (years) | 2.00 (1.64; 0.01–5.38) | 1.98 (1.65; 0.01–5.40)”

Table 1Find in source

paraphrase[Table 1]

“Ethnicity (%) | White | 172 (78.5) | 173 (82.8)”

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceINADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Ethical approval and informed consent are adequately reported.

Evidence

“The trial was approved by West of Scotland Research Ethics Service, Committee 3 (15/WS/0280).”

MethodsFind in source

“From January 2012 to June 2015, participants were asked for consent, assessed at baseline and then randomized.”

MethodsFind in source

absence[Methods, Study design and participants]

Regulatory compliance is not explicitly named.

PASSReviewer 2· 95% conf

The trial has a named ethics committee approval and describes informed consent procedures, including deferred consent. Regulatory compliance is implied through adherence to ethical standards.

Evidence

“The trial was approved by West of Scotland Research Ethics Service, Committee 3 (15/WS/0280).”

MethodsFind in source

paraphrase[Methods, Procedures]

Sub-criteria

mycoplasma testingN/A

reagents identifiedADEQUATE

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 80% conf

The investigational product (NIM) is described in detail, and software tools are identified.

Evidence

Introduction ¶4Find in source

“The primary analysis, conducted in R version 4.1.1 (2021-08-10) for Windows (with ‘lme4’ and ‘survival’ for TTPLS)”

Statistical analysisFind in source

PASSReviewer 2· 85% conf

The investigational product (NIM) is described in detail, and the comparator (SAU) is characterized. Software tools are identified. No bench reagents are used.

Evidence

Introduction ¶4Find in source

“The primary analysis, conducted in R version 4.1.1 (2021-08-10) for Windows (with ‘lme4’ and ‘survival’ for TTPLS)”

Statistical analysisFind in source

Sub-criteria

tests namedADEQUATE

exact p valuesADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedADEQUATE

assumptions verifiedADEQUATE

mathematical plausibilityPASS

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 85% conf

Statistical methods are appropriate and well-described, with exact p-values and effect sizes with confidence intervals.

Evidence

paraphrase[Methods, Statistical analyses]

“SDQ-TD score a | 11.5 (7.6) | 11.1 (7.2) | 1.44 | (−0.63, 3.53) | 0.17”

Table 2Find in source

“Mean difference (or HR) | 95% CI | P value”

Table 2Find in source

PASSReviewer 2· 90% conf

Evidence

Statistical analysisFind in source

“SDQ-TD score a | 11.5 (7.6) | 11.1 (7.2) | 1.44 | (−0.63, 3.53) | 0.17”

Table 2Find in source

“PIRGAS score a | 83.66 (12.73) | 84.83 (9.85) | −2.82 | (−8.53, 2.84) | 0.33”

Table 2Find in source

Sub-criteria

code sharingNOT REPORTED

accession numbersN/A

repository depositN/A

data availability statementADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 85% conf

Data availability is described with a concrete access mechanism, and code is available via supplementary materials.

Evidence

Data availabilityFind in source

absence[Data availability]

Code is not shared in a public repository.

PASSReviewer 2· 90% conf

Evidence

Data availabilityFind in source

“Data access will be provided through the secure analytical platform of the Robertson Centre for Biostatistics.”

Data availabilityFind in source

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineADEQUATE

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The trial is registered, follows CONSORT, reports all outcomes, discusses limitations, and provides funding and COI statements.

Evidence

“ClinicalTrials.gov registration: NCT02653716 (https://clinicaltrials.gov/study/NCT02653716)”

AbstractFind in source

“We used the CONSORT framework to report the findings (see the checklist in ).”

Statistical analysisFind in source

Discussion ¶7Find in source

PASSReviewer 2· 90% conf

The trial is registered, uses CONSORT reporting, reports all pre-specified outcomes, discusses limitations, and provides funding and COI statements.

Evidence

“ClinicalTrials.gov registration: NCT02653716 (https://clinicaltrials.gov/study/NCT02653716)”

AbstractFind in source

“We used the CONSORT framework to report the findings (see the checklist in ).”

Statistical analysisFind in source

Discussion ¶7Find in source

Registered (2 IDs: ClinicalTrials.gov). Reporting guideline cited: CONSORT.

Broken references and links

None found

References checked against Crossref, OpenAlex and Retraction Watch for retractions and resolvability, plus declared data and code links probed for whether they resolve to content matching the paper.

Checked — nothing surfaced.

Checked 33 references by DOI: 27 verified — 6 no DOI (shown, not verified).

2 data/code links checked; 2 live.

Copyediting

5 minor

Wording, consistency and formatting errors that need correcting before submission.

No major wording or formatting errors. 5 minor suggestions below.

5 copyedit issues flagged: mostly consistency, clarity, typo.

Kaimen Rigor Action ItemsFinal pass before journal submission

1.
HIGHethics
Add an explicit statement of regulatory compliance (e.g., 'The trial was conducted in accordance with the Declaration of Helsinki') in the Methods section.
Both reviewers flagged the absence of an explicit regulatory compliance statement, which is a standard ethical reporting requirement.
2.
HIGHdata code
Share the analysis code in a public repository (e.g., GitHub) with a DOI, or at least provide the statistical analysis plan as a supplementary file with version control.
Code sharing enhances reproducibility and is a common reviewer expectation for clinical trials.
3.
HIGHstatistics
Investigate the one inconsistent statistic flagged by the verification component (not specified in the report) and correct any typo or clarify the discrepancy.
An unexplained inconsistency in a reported test statistic could undermine reader confidence, even if it is likely a typographical error.
4.
MEDIUMreporting
Clarify the data availability statement by specifying the expected timeline for data access decisions and any criteria for approval.
Reviewer 2 noted the statement lacks a timeline and approval criteria, which would improve transparency for potential data requesters.
5.
MEDIUMreporting
In the Discussion, explicitly acknowledge the lack of a pre-specified plan for handling the sex interaction finding to avoid potential overinterpretation.
Reviewer 2 suggested this to ensure the sex-related finding is not overinterpreted without a pre-specified analysis plan.
6.
MEDIUMreporting
Provide more detail on the blinding of outcome assessors for the primary outcome (SDQ) to ensure complete transparency.
Reviewer 2 noted that blinding details for the primary outcome are less explicit than for secondary outcomes.
7.
MEDIUMreporting
Consider reporting the intracluster correlation coefficient for secondary outcomes as well.
Reviewer 2 suggested this to provide a more complete picture of clustering effects.
8.
MEDIUMreporting
In the CONSORT flow diagram, ensure all numbers reconcile (e.g., 382 families randomized vs. 360 after exclusions) with clear annotations.
The copyedit and integrity checks noted a potential discrepancy between consented and randomized numbers that could confuse readers.
9.
MEDIUMstatistics
Add a statement on whether any analyses were adjusted for multiple comparisons, as the paper notes no adjustments were made.
Reviewer 2 flagged this as a transparency issue for the interpretation of secondary outcomes.
10.
MEDIUMreporting
Specify the version of the statistical analysis plan and where it can be accessed.
Reviewer 2 suggested this to improve reproducibility and version control.
11.
LOWcopyedit
Fix the typo in the Abstract: 'BeST ?' should be 'BeST?' (likely a placeholder for a registered trademark symbol).
Copyedit flagged this as a minor typo that should be corrected for professionalism.
12.
LOWcopyedit
Ensure consistency in the number of families followed up at each time point (285 vs 286 families) in the Results section.
Copyedit flagged a minor inconsistency that could confuse readers.
13.
LOWcopyedit
Clarify that 'survival' is an R package in the Methods section.
Copyedit noted the sentence is slightly ambiguous.
14.
LOWcopyedit
Remove stray commas and citation placeholders in the Methods section (e.g., 'with ‘lme4’ and ‘survival’ for TTPLS) , , used').
Copyedit flagged formatting issues that should be cleaned up.
15.
LOWdata code
Consider including a data-sharing agreement template or reference to facilitate data access requests.
Reviewer 2 suggested this to streamline the data access process.

Full text (49,316 chars)Analyzed: Aug 15, 2026