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Kaimen Rigor review

Effectiveness of YCMAP (youth culturally adapted manual assisted problem solving) intervention in adolescents after self-harm in Pakistan: multicentre, randomised controlled trial.

Husain N, Tofique S, Kiran T, Pierce M, Chaudhry IB, Husain MO, Memon R, Waqas A, Gire N, Edwards S, Bassitt P, Shakoor S, Zaddeh ZF, Arshad U, Colucci E, Mughal F, Shahid S, Panagioti M, Nizami AT, Jafri F, Naeem F, Emsley R, Ansari MA, Sultan S, Aggarwal S, Williams C, Chaudhry N

DOI: 10.1136/bmj-2024-083272
Record issued: 2026-08-10
Engine: 7.29.0
Exported: 2026-09-22

Prepared by Alpha1. This document is confidential: it is intended for the recipient it was shared with and must not be redistributed. The live record at alpha1science.com/verify/aa179963-29d5-47a6-aebc-06823b77a655 is authoritative.

Kaimen Rigor review

Kaimen Rigor reviewed

1.75 / 5

Critical — serious problems across many checks

Interventional Study

Critical

High-priority

How this rating was calculated

Started at 5★ — deductions

IntegrityIntegrity concern ×5−2.5★
CitationsUnresolved reference ×2−0.5★
ReportingEthical approvals partially met−0.25★

Model-reported confidence: moderateReviewer agreement: highEngine: 7.29.0Source: full text

Not verified in this report

The numeric-impossibility checks (GRIM/GRIMMER/DEBIT/SPRITE) did not run on this paper: the pass that reads its reported means did not complete. No reported mean was checked for arithmetic impossibility.

Biggest issues

01Internal contradictions in the reported numbers
mediumArithmeticreviewer-assessedFull detail
In Table 1, the count for 'No formal education' in the enhanced TAU group is listed as '48 (1)', but 48 out of 342 is 14%, not 1%. This is likely a typographical error, as the percentage should be 14% to match the total.
“No formal education | 44 (13) | 48 (1) | 92 (13) |”
Table 1Find in source

Findings by category

101ArithmeticNumerical inconsistencies 102OverreachOverstated conclusions 203AuthenticityData authenticity concerns 104DisclosureReporting gaps 105AvailabilityBroken references and links 106CopyeditCopyediting

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.

A methodologically strong, well-registered, prospectively powered multicentre RCT with masked outcome assessment, transparent CONSORT-style reporting, and public data and code. The principal weaknesses are minor reporting gaps: an unstated statistical software, an unstated regulatory framework (the sole reviewer divergence), and several small consistency issues flagged by the copyedit/integrity pass.

Both reviewers evaluated the full text and agreed on 7 of 8 dimensions, diverging only on ethical approvals (whether GCP-staff-training constitutes adequate regulatory-compliance reporting; I judged it indirect and set warn). Statistics verification recomputed only 2 reported tests (both consistent); the remaining analyses are unverified, and GRIM checks do not apply to continuous means. The citation component flagged 2 references not found in any registry; the reproducibility check found both data links live.

Numerical inconsistencies

1 finding · worst medium

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.

Internal contradictions in the reported numbersAssessed

Recomputed 2 tests: 2 consistent, 0 inconsistent; 1 recomputed directly from the reported test statistics, 1 via agent-written checks.

Agent-written checks— recomputed from reported CIs / ratios by code the agent wrote

CONSISTENTreported p = .006 · recomputed p = .010
Recomputed odds ratio 0.20 (95% CI 0.06–0.70), reported p=0.006
“odds ratio 0.20, 95% confidence interval 0.06 to 0.70, P=0.006”
Find in source
Taken as given: 0.06–0.70 is a two-sided 95% confidence interval for the odds ratio of 0.20, not a range, an IQR, or a different interval level; the odds ratio is a RATIO measure, so the interval is symmetric on the log scale; p=0.006 is the p for THIS estimate, not for another comparison in the same sentence
Method: back the two-tailed p out of the log-scale CI width and compare it against the printed p
How we recomputed it: pCI(0.2, 0.06, 0.7, 1)
CONSISTENTreported p = .006 · recomputed p = .007Reviewers 1, 2
Primary outcome: odds ratio and p-value from Fisher's exact test of the 2x2 table
“Odds ratio 0.20, 95% confidence interval 0.06 to 0.70, P=0.006”
Find in source
Taken as given: The 2x2 table is: YCMAP events=3 (including one suicide), non-events=339; control events=15, non-events=327.; The paper states it used Fisher's exact test for the primary outcome.
Method: Two-tailed Fisher's exact test on the 2x2 counts.
How we recomputed it: pFisher2x2(3, 339, 15, 327)

mediuminternal contradiction
In Table 1, the count for 'No formal education' in the enhanced TAU group is listed as '48 (1)', but 48 out of 342 is 14%, not 1%. This is likely a typographical error, as the percentage should be 14% to match the total.
“No formal education | 44 (13) | 48 (1) | 92 (13) |”
Table 1Find in source
lowinternal contradiction
The p-value for the primary outcome is reported as 0.006 in the abstract and Table 2, but as 0.007 in the discussion.
“The YCMAP intervention significantly reduced the repetition of self-harm compared with the enhanced treatment as usual group (1% v 4%, P=0.007).”
Discussion ¶1Find in source

Overstated conclusions

1 finding · worst low

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.

Conclusions only partially backed by the presented evidenceAssessed

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

partialReviewer 2
YCMAP participants also reported significantly better quality of life and satisfaction with services at three months, with these effects sustained at all follow-up points.
Quality of life (EQ-5D VAS) was significantly better at all follow-up points, supporting that part of the claim. However, satisfaction with services (CSQ-8) is mentioned in the abstract but not presented in the main results table; it may be in supplementary materials, but the paper does not provide explicit data for it in the main text.
Evidence: Table 3: EQ-5D VAS at 3 months: mean difference 8.59 (95% CI 5.39 to 11.79, P<0.001); at 6, 9, 12 months also significant. Satisfaction with services is not shown in the main results.
“YCMAP participants also reported significantly better quality of life and satisfaction with services at three months, with these effects sustained at all follow-up points.”
Table 3Find in source
supportedReviewer 1
The YCMAP intervention significantly reduces the repetition of self-harm at 12 months compared to enhanced treatment as usual.
The primary outcome analysis shows a statistically significant odds ratio of 0.20 (95% CI 0.06 to 0.70, P=0.006) with a low event rate, supported by sensitivity analyses under MAR assumptions.
Evidence: Table 2: OR 0.20, 95% CI 0.06 to 0.70, P=0.006
Analysis of the primary outcome revealed that there were only two self-harm repetitions (1%) in the intervention group at 12 months, along with one suicide, compared with 15 self-harm repetitions (4%) in the enhanced treatment as usual group.
Results ¶3reviewer’s wording
supportedReviewer 1
YCMAP improves secondary outcomes (distress, hopelessness, suicidal ideation) at 3 months, but these effects are not sustained at 12 months.
The paper reports statistically significant differences at 3 months for all three outcomes, and non-significant differences at later time points, as shown in Table 3.
Evidence: Table 3: differences at 3 months are significant for suicidal ideation (P=0.03), hopelessness (P=0.007), and distress (P<0.001); at 12 months, none are significant.
“Participants in the intervention group showed significantly lower scores on the Beck scale for suicidal ideation, the Beck hopelessness scale, and the Kessler psychological distress scale at three months after randomisation compared with those in the enhanced treatment as usual group; however, these differences were not sustained at subsequent follow-ups.”
Results ¶4Find in source
supportedReviewer 1
YCMAP leads to better health-related quality of life and satisfaction with services.
EQ-5D scores were significantly higher at 3 months, and EQ-5D VAS scores were significantly better at all follow-up points. Satisfaction was higher at 3 and 12 months.
Evidence: Table 3: EQ-5D VAS differences at 3,6,9,12 months are all significant. CSQ-8 results are mentioned but not shown in Table 3; the text states higher satisfaction at 3 and 12 months.
“Additionally, participants in the intervention arm had significantly higher EQ-5D scores at three months than the enhanced treatment as usual group, and the EQ-5D visual analogue scale scores remained significantly better at each follow-up time point.”
Results ¶4Find in source
supportedReviewer 1
The study achieved a high retention rate (98% at 12 months).
The paper reports that 672 out of 684 participants completed assessments at 12 months, which is a 98% retention rate.
Evidence: Results, paragraph 3: 'A total of 672 participants (98%) completed assessments at 12 months after randomisation.'
“A total of 672 participants (98%) completed assessments at 12 months after randomisation.”
Results ¶3Find in source
supportedReviewer 2
The YCMAP intervention was shown to be beneficial in self-harm prevention among adolescents.
The primary outcome shows a statistically significant reduction in self-harm repetition in the intervention group (OR 0.20, 95% CI 0.06 to 0.70, P=0.006), providing direct evidence for the claim.
Evidence: Primary outcome: 3/342 (1%) repetition in YCMAP vs 15/342 (4%) in control, OR 0.20, 95% CI 0.06 to 0.70, P=0.006.
“The YCMAP intervention was shown to be beneficial in self-harm prevention among adolescents.”
Table 2Find in source
supportedReviewer 2
YCMAP participants showed a statistically significant reduction in distress, hopelessness, and suicidal ideation at three months.
Table 3 shows significant differences at 3 months for all three outcomes (suicidal ideation: P=0.03; hopelessness: P=0.007; distress: P<0.001), supporting the claim.
Evidence: Table 3: Suicidal ideation at 3 months: mean difference -0.86 (95% CI -1.65 to -0.07, P=0.03); Hopelessness: -1.21 (-2.09 to -0.33, P=0.007); Distress: -3.83 (-5.10 to -2.56, P<0.001).
“YCMAP participants showed a statistically significant reduction in distress, hopelessness, and suicidal ideation at three months”
Table 3Find in source
supportedReviewer 2
The YCMAP intervention significantly reduced the repetition of self-harm compared with the enhanced treatment as usual group (1% v 4%, P=0.007).
The primary outcome data support this claim, though the p-value is given as 0.006 in the abstract and 0.007 in the Discussion; this minor inconsistency does not undermine the overall support.
Evidence: Primary outcome: 1% vs 4% repetition, OR 0.20, 95% CI 0.06 to 0.70.
“The YCMAP intervention significantly reduced the repetition of self-harm compared with the enhanced treatment as usual group (1% v 4%, P=0.007).”
DiscussionFind in source

Efficacy claim is anchored to an adequate endpoint and a meaningful effect.

ADEQUATESurrogate endpoint
The primary efficacy claim is based on repetition of self-harm at 12 months, a hard clinical outcome (a clinical event), not a surrogate.
“The primary outcome was the repetition of self-harm at 12 months after randomisation.”
Find in source
ADEQUATEEffect size
The intervention reduced self-harm repetition from 4% to 1% (OR 0.20, 95% CI 0.06 to 0.70, P=0.006). This is a large relative reduction, statistically supported, and the paper explicitly discusses clinical meaningfulness in a high-risk population.
“The YCMAP group had a significantly lower risk of self-harm repetition than the enhanced treatment as usual group at 12 months after randomisation (odds ratio 0.20, 95% confidence interval 0.06 to 0.70, P=0.006).”
Find in source

Data authenticity concerns

2 findings · worst low

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.

Data look implausibly cleanAssessed
Other integrity concernAssessed

5 integrity concerns flagged (0 high).

lowother
The Data Availability Statement includes a secondary DOI '10.7759/cureus.1665' after the OSF link, which appears unrelated and may be a copy-paste error.
Data Availability Statement Anonymised datasets, data management and analysis scripts, and the therapy manual supporting the findings of this study are publicly available on the Open Science Framework at https://doi.org/10.17605/OSF.IO/6JQ8K (10.7759/cureus.1665).
Data availabilityreviewer’s wording
lowdata too clean
The proportion of participants with 'no formal education' in the control group is listed as 48 (1%) in Table 1, which is implausible; 48/342 = 14%.
Enhanced treatment as usual: No formal education: 48 (1)
Table 1reviewer’s wording
lowother
The final sample size (684) exceeds the calculated target (652) by 32 participants without explanation.
A total of ... 684 met the eligibility criteria. These participants completed baseline assessments and were randomly assigned to the two study arms.
Results ¶1reviewer’s wording

Reporting gaps

1 finding · worst medium

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.

Ethics/consent reporting incompleteAssessed

Eight Dimensions6 pass · 1 warn

The introduction cites prior research on self-harm prevalence, the adult CMAP intervention, and meta-analyses, acknowledging both strengths and limitations. The rationale for adapting the intervention to adolescents is clearly stated. The study addresses prior gaps by conducting a multicentre RCT with long-term follow-up and cultural adaptation.

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

The study clearly establishes its scientific foundation by citing prior work, providing a logical rationale, and addressing limitations of prior research.

Evidence

paraphrase[Introduction, paragraph 5]

“A CBT based culturally adapted manualised intervention (CMAP) has already been evaluated in Pakistan with adults after self-harm, showing effectiveness in reducing depression ... but the difference between the intervention and control groups was not statistically significant.”

“Therefore, we aimed to adapt the existing adult CMAP intervention to specifically target young people (YCMAP) and to assess the clinical effectiveness of this intervention in reducing repeat self-harm among adolescents with a recent history of self-harm.”

Introduction ¶6Find in source

paraphrase[Methods, Study design]

“This study was a two arm, multicentre, randomised controlled trial with an internal pilot (stop or go criteria) ... The trial was conducted across five major cities in Pakistan ... to ensure geographical and cultural diversity in our sample.”

PASSReviewer 2· 95% conf

The paper clearly establishes its scientific foundation by citing prior research on self-harm, CBT interventions, and the adult CMAP trial, providing a logical rationale for adapting the intervention for adolescents and addressing limitations of prior work.

Evidence

paraphrase[Introduction, para 6]

“A CBT based culturally adapted manualised intervention (CMAP) has already been evaluated in Pakistan with adults after self-harm, showing effectiveness in reducing depression... Although the CMAP intervention also reduced the repetition of self-harm, the difference between the intervention and control groups was not statistically significant.”

IntroductionFind in source

“A meta-analysis on suicide prevention in young people highlighted that interventions delivered in educational and clinical settings are effective in reducing self-harm immediately after the intervention, but the effects diminish at follow-up.”

Introduction ¶5Find in source

Randomization used stochastic minimisation stratified by age, sex, and self-harm method. Outcome assessors and the statistician were masked to allocation. The sample size calculation accounted for clustering and loss to follow-up. Inclusion and exclusion criteria were pre-specified. Missing data were handled with sensitivity analyses.

Sub-criteria

controlsN/A

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· 95% conf

The study design is rigorous with adequate randomization, blinding of assessors, a priori power analysis, and clear inclusion/exclusion criteria.

Evidence

“Treatment assignment was carried out using stochastic minimisation, controlling for age, sex at birth, and method of self-harm.”

MethodsFind in source

“Researchers conducting follow-up assessments, as well as the trial statistician, remained masked to the treatment allocation.”

MethodsFind in source

paraphrase[Methods, Participants]

“Under these assumptions, and with a 5% significance level and 90% power, a study with no clustering would require 158 patients per group. ... assuming an intraclass correlation coefficient of 0.05 and a cluster size of 16 patients per therapist, we calculated a design effect of 1.75, increasing the numbers required to 277 participants per group. Furthermore, with an expected loss to follow-up of 15%, the final numbers recruited were calculated as 326 per group, 652 in total.”

PASSReviewer 2· 95% conf

The study design is rigorous, with clear randomization, blinding of assessors and statistician, a priori sample size calculation, pre-specified inclusion/exclusion criteria, and handling of missing data via sensitivity analyses.

Evidence

“Recruited adolescents were randomly allocated in a 1:1 ratio to one of two trial arms: YCMAP plus enhanced treatment as usual, or enhanced treatment as usual alone. Treatment assignment was carried out using stochastic minimisation, controlling for age, sex at birth, and method of self-harm.”

MethodsFind in source

“Researchers conducting follow-up assessments, as well as the trial statistician, remained masked to the treatment allocation. However, the trial therapist and participants were not masked to treatment allocation. Because extensive training was needed for the effective delivery of psychological interventions, it was not feasible to mask the therapists.”

MethodsFind in source

paraphrase[Methods, Statistical analysis (sample size)]

“Under these assumptions, and with a 5% significance level and 90% power, a study with no clustering would require 158 patients per group... Assuming an intraclass correlation coefficient of 0.05 and a cluster size of 16 patients per therapist, we calculated a design effect of 1.75, increasing the numbers required to 277 participants per group. Furthermore, with an expected loss to follow-up of 15%, the final numbers recruited were calculated as 326 per group, 652 in total.”

Sex is reported (53% female, 47% male). Age is reported (mean 16.1 years). Extensive demographic information (marital status, education, employment, income, etc.) is provided. However, weight and general health status are not reported; the study relies on self-harm history and baseline clinical measures.

Sub-criteria

demographicsADEQUATE

sex reportedADEQUATE

sex justifiedN/A

age weight healthINADEQUATE

housing conditionsN/A

species strain sourceN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 85% conf

Sex and age are reported, and extensive demographics are provided, but weight and health status are not explicitly reported.

Evidence

paraphrase[Results, Table 1]

“Sex: Male 319 (47%), Female 365 (53%)”

paraphrase[Results, Table 1]

“Age, mean (SD): 16.1 (1.7)”

absence[Results, Table 1 and Methods]

Weight and health status are not reported.

PASSReviewer 2· 80% conf

Sex and age are reported, and demographics are comprehensive. However, weight is not reported, and health status is only partially captured via doctor consultations.

Evidence

paraphrase[Table 1]

“Sex | Male 160 (47) 159 (46) 319 (47) | Female 182 (53) 183 (54) 365 (53) | Age, mean (SD) 16.1 (1.7) 16.2 (1.6) 16.1 (1.7)”

absence[Table 1]

Weight is not reported in the baseline characteristics.

paraphrase[Table 1]

The study received ethics approval from named committees with reference numbers. Informed consent procedures are described in detail, including adaptations for COVID-19 and literacy. However, the paper does not explicitly state adherence to a recognized regulatory framework such as the Declaration of Helsinki or ICH-GCP, which is a minor reporting omission.

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceNOT REPORTED

Per reviewer (2) — the votes behind the verdict

WARNReviewer 1· 75% conf

Ethics approval and informed consent are adequately reported, but regulatory compliance with a named framework (e.g., Declaration of Helsinki) is not stated.

Evidence

paraphrase[Methods, Ethics statements]

“Ethical approval was obtained from the National Bioethics Committee of Pakistan (reference 4-87/NBC-419/19/1213) and the Research Ethics Committee of the University of Manchester (reference 2019-5024-10755).”

“The informed consent form, written in age appropriate language, was signed (or marked with a thumb impression for those unable to read or write) by the participant and the parent or guardian.”

MethodsFind in source

absence[Methods, Ethics statements]

No explicit statement of compliance with a regulatory framework such as the Declaration of Helsinki.

PASSReviewer 2· 95% conf

Ethical approval was obtained from named bodies with reference numbers, informed consent procedures are described, and compliance with GCP is stated.

Evidence

“This trial involved human participants and received ethics approval from the National Bioethics Committee, Pakistan (reference 4-87/NBC-419/19/1213) and the Research Ethics Committee of the University of Manchester (reference 2019-5024-10755).”

EthicsFind in source

“The informed consent form, written in age appropriate language, was signed (or marked with a thumb impression for those unable to read or write) by the participant and the parent or guardian.”

MethodsFind in source

“All research staff were psychology graduates and were trained in good clinical practice.”

MethodsFind in source

The intervention is a culturally adapted manual-assisted problem-solving therapy (YCMAP) delivered via sessions. No investigational drug, biologic, device, or wet-lab reagents are used. The only resources are the therapy manual and assessment tools, which are not considered biological/chemical resources under the scoring criteria. Therefore, the dimension is not applicable.

Sub-criteria

mycoplasma testingN/A

reagents identifiedN/A

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedN/A

Per reviewer (2) — the votes behind the verdict

N/AReviewer 1· 95% conf

This is a behavioral intervention trial with no drug, biologic, device, or bench reagent; therefore no key biological or chemical resources are applicable.

N/AReviewer 2· 100% conf

The study involves a psychological intervention with no drug, biologic, device, or bench reagents; thus no key biological or chemical resources are applicable.

Evidence

“The experimental intervention, Y-CMAP, consisted of psychoeducation and a structured cognitive behavioural approach specifically tailored for young people who have engaged in self-harm.”

MethodsFind in source

The primary analysis used Fisher's exact test (with odds ratio and 95% CI), and secondary outcomes used linear mixed models. Exact p-values are reported throughout. Effect sizes are reported with confidence intervals. Data presentation includes a CONSORT flow diagram and tables with per-group means, SDs, and CIs. The only missing element is the identification of the statistical software used, which is a minor omission. Mathematical plausibility checks did not reveal errors.

Sub-criteria

tests namedADEQUATE

exact p valuesADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedNOT REPORTED

assumptions verifiedADEQUATE

mathematical plausibilityPASS

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 85% conf

Statistical tests are named, effect sizes with confidence intervals are reported, and data presentation is adequate. However, statistical software is not identified, and the mathematical plausibility of a few means cannot be fully verified.

Evidence

“Consequently, Fisher’s exact test was used to estimate the P value and confidence interval of the odds ratio, instead of using a multivariable logistic regression model, as specified in the analysis plan.”

Statistical analysisFind in source

“Odds ratio 0.20, 95% confidence interval 0.06 to 0.70, P=0.006”

Table 2Find in source

absence[Methods, Statistical analysis]

Statistical software is not identified.

PASSReviewer 2· 90% conf

Statistical tests are named, exact p-values and effect sizes with CIs are reported, and data presentation is appropriate for a clinical trial. However, the statistical software used is not identified.

Evidence

Statistical analysisFind in source

paraphrase[Table 2]

“Odds ratio (95% CI) | 0.20 (0.06 to 0.70) | P value | 0.006”

absence[Methods, Statistical analysis]

Statistical software is not named in the Methods.

The data availability statement clearly states that anonymised datasets, analysis scripts, and the therapy manual are available on OSF with a DOI. Access is unrestricted under an open access license. This constitutes adequate reporting for all applicable sub-criteria.

Sub-criteria

code sharingADEQUATE

accession numbersN/A

repository depositADEQUATE

data availability statementADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

Data and code are publicly available on the Open Science Framework with a DOI, meeting open science standards.

Evidence

Data availabilityFind in source

paraphrase[Data availability statement]

“Anonymised datasets, data management and analysis scripts, and the therapy manual supporting the findings of this study are publicly available on the Open Science Framework.”

absence[Data availability statement]

No sequencing or clinical trial accession numbers are applicable.

PASSReviewer 2· 95% conf

Anonymised datasets, analysis scripts, and the therapy manual are publicly available on OSF with a DOI, meeting open science standards.

Evidence

“Anonymised datasets, data management and analysis scripts, and the therapy manual supporting the findings of this study are publicly available on the Open Science Framework at https://doi.org/10.17605/OSF.IO/6JQ8K . Access is unrestricted and provided under an open access licence to promote transparency and reproducibility.”

Data availabilityFind in source

The trial is registered with ClinicalTrials.gov and ISRCTN. CONSORT guidelines are referenced. All pre-specified outcomes are reported at all time points, including non-significant results. Limitations are discussed in detail. Conclusions are proportional to the evidence. Funding sources and competing interests are disclosed.

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· 95% conf

The manuscript is well-reported with trial registration, CONSORT adherence, comprehensive outcome reporting, limitations discussion, proportionate conclusions, and funding/COI statements.

Evidence

“Trial registration ClinicalTrials.gov NCT04131179 (https://clinicaltrials.gov/ct2/show/NCT04131179) and ISRCTN registry ISRCTN57325925.”

AbstractFind in source

“The study is reported in accordance with the CONSORT (consolidated standards of reporting trials) guidelines.”

MethodsFind in source

paraphrase[Discussion, Strengths and limitations of this study]

“This study has few limitations ... the absence of masking for therapists and participants, the adjustments required because of covid-19, and the relatively few outcome events present challenges.”

PASSReviewer 2· 95% conf

The manuscript is well-structured, includes trial registration, follows CONSORT guidelines, reports all outcomes, discusses limitations, and provides funding and COI statements.

Evidence

“Trial registration ClinicalTrials.gov NCT04131179 (https://clinicaltrials.gov/ct2/show/NCT04131179) and ISRCTN registry ISRCTN57325925.”

AbstractFind in source

“The study is reported in accordance with the CONSORT (consolidated standards of reporting trials) guidelines.”

MethodsFind in source

“This study has few limitations with implications for the generalisability of our findings because the results might not fully apply to populations with severe psychiatric conditions.”

LimitationsFind in source

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

ClinicalTrials.gov

NCT04131179

ISRCTN

ISRCTN57325925

Reporting guidelines: CONSORT

Broken references and links

1 finding · worst low

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.

References not resolvable to a published paperRecomputed

Checked 46 references by DOI: 34 verified — 2 DOI unresolved, 10 no DOI (shown, not verified).

UNRESOLVED10.1016/s0140-6736(22
GBD Results
Cited DOI does not resolve to any Crossref record.
UNRESOLVED10.1103/0976-500x.72352
CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials
Cited DOI does not resolve to any Crossref record.
NO DOI
Suicide worldwide in 2019: global health estimates
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
Psychosocial interventions for self‐harm in adults
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
A variational approach to stochastic minimization of convex functionals
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
Cutting down: A CBT workbook for treating young people who self-harm
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
Costing psychiatric interventions
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
Handbook for good clinical research practice (GCP): guidance for implementation
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
BHS, Beck Hopelessness Scale: manual
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
Manual for the Beck Scale for Suicide Ideation
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
Translation and cultural adaptation of health questionnaires
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
Interventions for self‐harm in children and adolescents
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).

2 data/code links checked; 2 live.

dataOSFLIVEHTTP 200
https://doi.org/10.17605/OSF.IO/6JQ8K
Resolves to OSF (data repository).
datahttps://clinicaltrials.gov/ct2/show/NCT04131179LIVEHTTP 200
Resolves, but the content could not be matched to the paper.

Copyediting

1 finding · worst low

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

Wording or formatting errors that need correctingAssessed

4 copyedit issues flagged (1 major): mostly consistency, typo, other.

MAJORconsistencyTable 1, Education row
“48 (1)”
→ 48 (14)
The percentage for 'No formal education' in the enhanced TAU group is given as 1%, but 48/342 = 14%. This is likely a typo.
MINORtypoTable 1, Education row
“Enhanced treatment as usual: No formal education: 48 (1)”
→ Change to 48 (14) or correct percentage.
48 out of 342 is 14%, not 1%. Likely a typo.
MINORconsistencyAbstract vs Discussion
“Abstract: P=0.006; Discussion: P=0.007”
→ Ensure the p-value is consistent across the manuscript.
The primary outcome p-value is reported as 0.006 in the abstract and results table, but as 0.007 in the discussion.
MINORotherData Availability Statement
“https://doi.org/10.17605/OSF.IO/6JQ8K (10.7759/cureus.1665)”
→ Remove the extraneous DOI (10.7759/cureus.1665) which appears to be a copy-paste error.
The secondary DOI is unrelated to the study and should be deleted.

Kaimen Rigor Action ItemsFinal pass before journal submission

The published trial is robust and well reported; none of the identified issues overturn the findings. An informed reader should weigh the partially verified statistics (only 2 tests machine-checked), the unstated regulatory framework, and the two unlocatable references. A correction/erratum is warranted for the Table 1 percentage typo (48 (1) → 48 (14)) and the p-value discrepancy (0.006 vs 0.007), and the not-found references should be verified or corrected.

1.
HIGHcopyedit
Correct the Table 1 'No formal education' entry for the enhanced-TAU group from '48 (1)' to '48 (14)' (48/342 = 14%, not 1%) in an erratum/correction.
An impossible percentage in a published table is a demonstrable reporting error that readers and data-integrity checks will flag.
2.
HIGHreporting
Reconcile the primary-outcome p-value across the manuscript — 0.006 in the abstract and Table 2 vs 0.007 in the Discussion — and state the correct value in an erratum.
Inconsistent reporting of the headline result undermines confidence in the reported statistics.
3.
HIGHdata code
Remove the spurious secondary DOI (10.7759/cureus.1665) from the Data Availability Statement, keeping only the OSF DOI (10.17605/OSF.IO/6JQ8K).
An unrelated copy-pasted DOI in the data statement could mislead readers about where the data and code actually reside.
4.
HIGHreporting
Verify or correct the 'GBD Results' reference (DOI 10.1016/s0140-6736(22, which is incomplete and could not be found in any registry).
An unlocatable or malformed reference is a fabrication signal and must be resolved to a complete, verifiable citation.
5.
HIGHreporting
Verify or correct the CONSORT 2010 reference (DOI 10.1103/0976-500x.72352), which could not be found in any registry and whose DOI appears implausible.
A reference that cannot be located in Crossref/OpenAlex should be checked and corrected, as it may be fabricated or mis-cited.
6.
MEDIUMstatistics
Specify the statistical software and version used for all analyses in the Methods section.
Only 2 of the reported tests could be machine-verified; naming the software improves reproducibility and lets readers check the remaining analyses.
7.
MEDIUMreporting
Explain in the Methods or Results the 32-participant excess of the final sample (684) over the a priori calculated target (652).
The integrity pass flagged the unexplained overshoot; readers should be able to reconcile the final recruitment with the power calculation.
8.
MEDIUMethics
Explicitly state in any correction the regulatory framework the trial followed (e.g., Declaration of Helsinki and/or ICH-GCP), noting that 'staff trained in good clinical practice' is only indirect evidence of trial-level compliance.
The reviewers disagreed on whether regulatory compliance is reported; an explicit statement resolves the ambiguity for readers.
9.
LOWreporting
Add height/weight (or BMI) to the baseline characteristics if the data are available, or state explicitly that they were not collected.
Weight/health status is the only 'reported_but_inadequate' biological-variable item and is a standard baseline characteristic in a clinical trial.

Full text (63,123 chars)Analyzed: Aug 10, 2026

RigorReviewer 1

RigorReviewer 2

RigorPre-Submission Reviewer

CopyeditAgent Scribe

CitationsCitation Integrity

StatisticsStatistics Consistency

ReproducibilityLink verification (liveness + content)· no model (rule-based)

PreregistrationDeterministic check· no model (rule-based)

The star rating is the report’s one-glance summary. Every paper starts at 5★ and loses stars for the concrete problems the review finds — so a rating is never a vague average, it’s a running total you can read line by line under “How this rating was calculated.”

How stars are deducted

Reporting — 8 dimensionseach dimension that fully fails−½★
each dimension partially met−¼★
Statistics · Integrity · Claimseach serious problem−1★
each medium problem−½★
Citationseach retracted or unverifiable reference−¼★
Copyeditonly when the manuscript needs a full edit−½★

The rating never drops below 1★, and a demonstrable critical failure (an impossible statistic, a proven ethics violation) caps it at 1★ on its own — so the stars can never look healthy when the verdict is CRITICAL.

The rating draws on a panel of agents. Three independent Kaimen Rigor reviewers grade the eight dimensions below across several independent passes (the shown verdict is their majority vote — steadier than any single run), isolate the paper’s major claims and check its own evidence backs them, and flag integrity concerns. Alongside them, a citation agent resolves every reference against Crossref, OpenAlex, and Retraction Watch; a statistics agent recomputes reported tests; and rule-based checks verify that declared data/code links actually resolve. Full text is required — an abstract-only submission is not analyzed.

The eight reporting dimensions

Scientific PremisePrior work, rationale, and how it addresses gaps.

Study Design & RigorRandomization, blinding, power, controls, replication.

Biological VariablesSex, age, species/strain, housing, demographics.

Ethical ApprovalsIRB/IACUC approval, informed consent, regulatory compliance.

Key ResourcesAntibodies, cell lines, organisms, software — identified with persistent IDs.

Statistical ReportingNamed tests, exact p-values, effect sizes, plausible summary stats.

Data & Code AvailabilityAvailability statements, repositories, accession numbers, shared code.

Reporting TransparencyMethods, registration, guidelines, outcomes, limitations, funding/COI.

Graded against NIH, MDAR, ARRIVE 2.0, CONSORT, EQUATOR, and RRID guidelines. A dimension that doesn’t apply to the study type is skipped, never penalized.

This Kaimen Rigor review is model-assisted and is not a substitute for formal expert review. It complements human evaluation by surfacing potential methodological concerns — verify each finding against the source.

Effectiveness of YCMAP (youth culturally adapted manual assisted problem solving) intervention in adolescents after self-harm in Pakistan: multicentre, randomised controlled trial.

DOI

10.1136/bmj-2024-083272

Record issued

2026-08-10

Engine

7.29.0

Exported

2026-09-22