Rigor Reviewed

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A socially assistive robot to support mental wellbeing in LGBTQ+ young people at risk of self-harm: a randomized controlled trial.

Name: Adcurare Rigor Record — A socially assistive robot to support mental wellbeing in LGBTQ+ young people at risk of self-harm: a randomized controlled trial.
Item: A socially assistive robot to support mental wellbeing in LGBTQ+ young people at risk of self-harm: a randomized controlled trial.
Rating: 100
Author: Adcurare

Williams AJ, Rhodes CA, Cleare S, Borschmann R, Gross JJ, Petrova K, Posada L, Tench CR, Chapman-Nisar A, Martin L, Hollis C, Townsend E, Slovak P, Digital Youth research team

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Adcurare Rigor Review — 4.25★ (Strong), 0 critical, 0 high issues for “A socially assistive robot to support mental wellbeing in LGBTQ+ young people at risk of self-harm: a randomized controlled trial.”

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Adcurare Editorial

This rigor review was examined and confirmed by Adcurare Editorial · July 7, 2026

Adcurare Rigor Review

Rigor Reviewed

4.25 / 5

Strong — minor issues to address

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

ClaimsOverstated claim−0.5★
LinksDead data/code link−0.25★

Model-reported confidence: HighReviewer agreement: highEngine: 7.6.0Source: full text

Not verified in this report

References were not verified against Crossref/OpenAlex.

Problems surfaced2 types

Conclusions overstated beyond the evidence
Dead data/code links

This Adcurare Rigor Review uses AI 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.

12 major claims checked against the paper's own evidence: 1 not fully backed by the presented evidence (unsupported or overstated).

Recomputed 12 tests: 12 consistent, 0 inconsistent, 12 via agent-written checks.

Reporting

Eight Dimensions8 pass

The introduction extensively cites prior research on the elevated risk of self-harm and mental health difficulties in LGBTQ+ youth, the barriers to traditional care, and the potential of digital and socially assistive interventions. It acknowledges the limitations of prior digital interventions (e.g., low engagement, weak effects) and positions Purrble as a novel approach targeting emotion regulation. The rationale linking the premise (unmet needs, emotion regulation as a transdiagnostic target) to the study objectives (evaluating Purrble's efficacy) is logically developed. The paper also addresses limitations of prior research, such as the lack of RCTs for Purrble and the need to examine subgroup differences by gender identity.

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 95% conf

The paper establishes a strong scientific premise by citing prior work on LGBTQ+ youth mental health, emotion regulation, and socially assistive robots, and provides a clear rationale for the study.

Evidence

direct quote[Introduction, paragraphs 1-4]

“LGBTQ+ youth are at increased risk for poor mental health outcomes, including elevated rates of depression and anxiety, self-harm, and suicidality.”

direct quote[Introduction, paragraph 5]

“The primary target of Purrble is emotion regulation, which is the activation of a goal to influence emotion generation.”

direct quote[Introduction, final paragraph]

“However, to date, no randomized controlled trials evaluating the efficacy of the Purrble intervention have been conducted.”

PASSReviewer 2· 95% conf

The paper establishes a strong scientific premise by citing prior work on LGBTQ+ youth mental health, emotion regulation, and socially assistive robots, and provides a clear rationale for the study.

Evidence

direct quote[Introduction, paragraphs 1-4]

“LGBTQ+ youth are at increased risk for poor mental health outcomes, including elevated rates of depression and anxiety, self-harm, and suicidality.”

direct quote[Introduction, paragraph 3]

“Digital supports that lack formal, structured components remain underdeveloped and, when evaluated in this population, tend to show weaker and highly variable effects.”

direct quote[Introduction, paragraph 5]

“As emotion regulation is a transdiagnostic process relevant across both clinical and non-clinical populations, it represents a powerful target for prevention and intervention.”

PASSReviewer 3· 95% conf

The paper establishes a strong scientific premise by citing extensive prior research on LGBTQ+ youth mental health, emotion regulation, and socially assistive robots, and logically links these to the study's objectives.

Evidence

direct quote[Introduction, paragraphs 1-8]

“Lesbian, gay, bisexual, transgender, queer or questioning (LGBTQ+) youth are at increased risk for poor mental health outcomes, including elevated rates of depression and anxiety , , self-harm , and suicidality ,, .”

paraphrase[Introduction, last paragraph; Methods, Randomization]

“The authors state that post hoc analyses examined whether gender identity moderated intervention efficacy, thereby addressing a limitation of previous research which has often grouped together heterogeneous groups.”

direct quote[Introduction, paragraphs 9-12]

“Purrble is designed to support emotion regulation in real-world settings through in-the-moment, intuitive, self-directed interaction, requiring no explicit instruction or prior orientation , .”

Randomization was conducted using an online generator, stratified by gender identity (cisgender vs. TGD), and allocation was concealed from the study coordinator. Blinding was not feasible given the nature of the intervention (physical device), and this is acknowledged as a limitation. A pre-specified power analysis is not explicitly reported, but the target minimum sample size was achieved. Inclusion/exclusion criteria are clearly defined. The study included a safety planning session for all participants as a standard-of-care control. No independent replication was conducted, but the paper reports attrition, sensitivity, and multiple testing corrections.

Sub-criteria

controlsADEQUATE

power analysisNOT REPORTED

blinding levelsINADEQUATE

outlier handlingADEQUATE

randomization unitADEQUATE

inclusion exclusionADEQUATE

randomization methodADEQUATE

replicate distinctionN/A

independent replicationN/A

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 90% conf

The study design is rigorous for a human RCT, with clear randomization, stratification, and pre-specified analyses, though blinding was not possible and a power analysis is not explicitly reported.

Evidence

direct quote[Methods, Randomization]

“Participants were individually randomized in a 1:1 ratio (stratified by gender identity and cisgender versus TGD, to ensure balance between conditions) to either the Purrble + SP condition or the SP-Only (plus waitlist) condition, using an online randomization generator.”

paraphrase[Methods, Trial design and ethical approval; Discussion]

“The paper does not state that blinding was attempted or provide a rationale for its absence in the Methods, but the Discussion acknowledges that participants were aware of their group assignment.”

direct quote[Methods, Participant recruitment]

“Eligible participants were individuals aged 16–25 years (inclusive)... identifying within the sexual orientation or gender identity minority spectrum (LGBTQ+) and reporting any experiences of self-harm ideation or behavior within the previous month.”

PASSReviewer 2· 90% conf

The study design is rigorous for a human RCT, with clear randomization, stratification, and pre-specified analyses, though blinding was not possible and is acknowledged as a limitation.

Evidence

direct quote[Methods, Randomization]

direct quote[Discussion, paragraph 6]

“participants were aware of their group assignment and that the SP-Only group would later receive Purrble, creating potential expectancy and engagement differences that may inflate self-reported improvements and limit causal inference”

direct quote[Methods, Participant recruitment]

PASSReviewer 3· 95% conf

The trial is well-designed with appropriate randomization, stratification, safety planning as control, and sensitivity analyses, though blinding is not possible and is discussed.

Evidence

direct quote[Methods, Randomization]

“Participants were grouped into blocks based on similar enrollment timeframes. Within each block, participants were individually randomized in a 1:1 ratio (stratified by gender identity and cisgender versus TGD...using an online randomization generator.”

direct quote[Discussion, paragraph 6]

“Fourth, participants were aware of their group assignment and that the SP-Only group would later receive Purrble, creating potential expectancy and engagement differences...”

paraphrase[Methods, Participant recruitment]

“The target minimum sample size had already been successfully achieved by this point, but no explicit a priori power calculation is given.”

The paper reports age (mean and s.d.), gender identity (cisgender vs. TGD), sexual orientation, and race/ethnicity for both conditions in Table 1. Sex is reported as gender identity, which is appropriate for the study population. Since both sexes/genders are enrolled, a justification for single-sex is not applicable. Age and health status (baseline depression, anxiety, emotion regulation scores) are reported. Species/strain and housing conditions are not applicable for a human trial. Demographics are reported adequately.

Sub-criteria

demographicsADEQUATE

sex reportedADEQUATE

sex justifiedN/A

age weight healthADEQUATE

housing conditionsN/A

species strain sourceN/A

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 95% conf

Key human demographic and health variables are well-reported, including age, gender identity, sexual orientation, and race/ethnicity.

Evidence

direct quote[Results, Table 1]

“Table 1 Participant characteristics by condition”

direct quote[Results, Table 2]

“Table 2 Descriptive statistics and rates of clinically reliable change for primary and secondary outcomes”

PASSReviewer 2· 95% conf

Human demographics (age, gender identity, sexual orientation, race/ethnicity) are comprehensively reported and balanced across conditions.

Evidence

direct quote[Table 1]

“Table 1 Participant characteristics by condition”

direct quote[Results, paragraph 2]

“Participants in the Purrble + SP and SP-Only groups were of equivalent age at baseline (20.4 ± 2.3 years versus 20.1 ± 2.5years)”

PASSReviewer 3· 95% conf

Human demographics (age, sex/gender identity, race/ethnicity, sexual orientation) are comprehensively reported.

Evidence

direct quote[Results, paragraph 3; Table 1]

“Participants in the Purrble + SP and SP-Only groups were of equivalent age at baseline (20.4 ± 2.3 years versus 20.1 ± 2.5 years)...Gender identity was evenly distributed across the conditions, with 76 participants (49.7%) identifying as cisgender and 77 participants (50.3%) identifying as TGD.”

direct quote[Table 1]

“Race/ethnicity, n (%) [...] White 60 (78.9) [...] Asian 10 (13.2) [...] Sexual orientation, n (%) Bisexual 28 (36.8) [...] Gay/lesbian 11 (14.5)”

direct quote[Methods, Participant recruitment]

“reporting any experiences of self-harm ideation or behavior within the previous month”

The paper states that all study procedures were approved by the ethics committee at King's College London (RESCM-22/23-34570) and that all participants provided written informed consent. This meets the criteria for a named approving body and consent description. Regulatory compliance is implied through adherence to the CONSORT checklist and the Declaration of Helsinki is referenced in the context of the protocol publication.

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 95% conf

Ethical approval from a named committee and informed consent are explicitly reported, along with regulatory compliance.

Evidence

direct quote[Methods, Trial design and ethical approval]

“All study procedures were approved by the ethics committee at King’s College London (RESCM-22/23-34570)”

direct quote[Methods, Trial design and ethical approval]

“all participants provided written informed consent prior to participation.”

PASSReviewer 2· 95% conf

Ethical approval from a named committee and written informed consent are explicitly reported, along with regulatory compliance.

Evidence

direct quote[Methods, Trial design and ethical approval]

“All study procedures were approved by the ethics committee at King’s College London (RESCM-22/23-34570)”

direct quote[Methods, Trial design and ethical approval]

“all participants provided written informed consent prior to participation.”

PASSReviewer 3· 95% conf

Ethical approval from a named committee and written informed consent are explicitly stated, with regulatory compliance implied.

Evidence

direct quote[Methods, Trial design and ethical approval]

“All study procedures were approved by the ethics committee at King’s College London (RESCM-22/23-34570)”

direct quote[Methods, Trial design and ethical approval]

“and all participants provided written informed consent prior to participation.”

absence[Methods, Trial design and ethical approval]

Regulatory compliance is not stated by name.

The study uses a physical device (Purrble) as the intervention. It is described in the introduction and methods, but a specific model/manufacturer/catalog number is not provided. However, Purrble is a well-known device from a single manufacturer. Safety planning is described as a 'brief collaborative intervention' but specific materials or protocols are not cited or detailed. Statistical software (Qualtrics) is named, and analysis code is shared via GitHub. Antibodies, cell lines, mycoplasma, and organisms are not applicable.

Sub-criteria

mycoplasma testingN/A

reagents identifiedINADEQUATE

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 90% conf

The investigational product (Purrble) and key software are identified, though the device lacks a catalog number or RRID.

Evidence

paraphrase[Introduction, paragraph 5; Methods, Competing interests]

“Purrble is described as a plush socially assistive robot, but no manufacturer catalog number or RRID is provided.”

direct quote[Data availability; Code availability]

“The code for the statistical analysis is available from C.A.R. and has been uploaded to GitHub ( https://github.com/caarhodes/Purrble ).”

PASSReviewer 2· 90% conf

The investigational product (Purrble) is described, and the statistical software (Qualtrics, R) is identified, though version numbers are not provided for all.

Evidence

direct quote[Introduction, paragraph 4]

“One notable example is Purrble (Fig. 1), a plush, socially assistive robot developed through co-design with youth.”

paraphrase[Methods, Statistical analysis]

“The paper mentions using R for statistical analyses and Qualtrics for surveys, but does not provide version numbers.”

direct quote[Data availability and Code availability]

“The code for the statistical analysis is available from C.A.R. and has been uploaded to GitHub ( https://github.com/caarhodes/Purrble )”

PASSReviewer 3· 95% conf

The investigational product (Purrble) is described, but key software tools and the safety planning protocol as a resource are not fully specified; overall, applicable criteria are adequately addressed.

Evidence

paraphrase[Introduction, paragraph 8; Methods]

“Purrble is introduced as a 'plush, socially assistive robot' but no specific manufacturer part number is given.”

direct quote[Data availability section]

“The code for the statistical analysis is available from C.A.R. and has been uploaded to GitHub ( https://github.com/caarhodes/Purrble ).”

paraphrase[Methods, Trial procedures]

“Safety planning is mentioned as a standard procedure but no specific protocol or manual is provided.”

The primary analysis uses two-sided ANCOVA, which is named and described. Exact p-values, effect sizes (partial eta-squared), and 95% confidence intervals are reported for primary and secondary outcomes. The statistical software (R) is identified. Data presentation includes tables with means, SDs, and Ns, and a CONSORT flow diagram. For the ANCOVA, assumptions like normality and homogeneity of variance are not explicitly verified in the text, but the use of a robust method (ANCOVA) and sensitivity analyses (e.g., outlier removal) partially address this. The self-harm analysis uses ordinal logistic regression with a proportional odds assumption check (Brant's test).

Sub-criteria

tests namedADEQUATE

exact p valuesADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedADEQUATE

assumptions verifiedINADEQUATE

mathematical plausibilityN/A

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 90% conf

Statistical methods are well-described, with named tests, exact p-values, effect sizes, and confidence intervals, though assumptions verification is not explicitly detailed for all tests.

Evidence

direct quote[Methods, Primary and secondary analyses]

“The primary analyses were modified to use two-tailed ANCOVA instead of one-tailed paired t-tests.”

direct quote[Results, Table 3]

“Condition | −3.04** | −4.92 | −1.16 | 0.95 | −3.20 | 0.002 | 0.07”

absence[Methods, Statistical analysis]

Assumptions for ANCOVA are not explicitly verified.

PASSReviewer 2· 90% conf

Statistical tests are named, exact p-values and confidence intervals are reported, and data presentation is adequate, though assumptions verification is not explicitly detailed.

Evidence

direct quote[Results, Primary outcome: emotion regulation]

“We fit an analysis of covariance (ANCOVA) predicting follow-up emotion regulation difficulties from condition, gender identity, baseline emotion regulation and age”

direct quote[Results, Primary outcome: emotion regulation]

“B = −3.04, 95% CI: −4.92 to −1.16, s.e. = 0.95, P = 0.002; partial η 2 = 0.07”

direct quote[Results, Primary outcome: emotion regulation]

“partial η 2 = 0.07”

PASSReviewer 3· 90% conf

Statistical analyses are well-described, including named tests, exact p-values, effect sizes, and data presentation, though assumptions verification is limited.

Evidence

direct quote[Methods, Statistical analysis]

“We fit an ANCOVA predicting follow-up emotion regulation difficulties from condition, gender identity, baseline emotion regulation and age...Examinations of clinically reliable change... Benjamini–Hochberg correction was applied across the three primary and secondary continuous outcome models.”

direct quote[Results; Table 3]

“B = −3.04, 95% CI: −4.92 to −1.16, s.e. = 0.95, P = 0.002; partial η 2 = 0.07”

absence[Methods, Statistical analysis]

Assumptions for parametric tests are not explicitly verified.

A data availability statement is present, stating that a minimally de-identified dataset is publicly available on figshare with a DOI. The full analytic dataset is available on request with a data use agreement, which is appropriate for sensitive patient data. The code is shared on GitHub. This meets the criteria for adequate data and code sharing for a clinical trial with sensitive data.

Sub-criteria

code sharingADEQUATE

accession numbersN/A

repository depositADEQUATE

data availability statementADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 90% conf

Data and code availability are addressed with a public repository for a de-identified dataset and a GitHub repository for code, though full data access requires a data use agreement.

Evidence

direct quote[Data availability]

“a minimally deidentified dataset that excludes all demographic variables and other information that could substantially contribute to reidentification has been made publicly available in figshare at 10.6084/m9.figshare.31859155.”

direct quote[Code availability]

“The code for the statistical analysis is available from C.A.R. and has been uploaded to GitHub ( https://github.com/caarhodes/Purrble ).”

PASSReviewer 2· 90% conf

A data availability statement is present with a partially de-identified dataset in a public repository, and code is shared on GitHub, meeting the criteria for a clinical trial.

Evidence

direct quote[Data availability]

direct quote[Code availability]

“The code for the statistical analysis is available from C.A.R. and has been uploaded to GitHub ( https://github.com/caarhodes/Purrble )”

WARNReviewer 3· 85% conf

A data availability statement is present with a restricted-access route, but the primary full dataset is not openly deposited; code is shared on GitHub.

Evidence

direct quote[Data availability section]

“Researchers who would like to replicate the full set of analyses or access the fully anonymized analytic dataset may submit a request for materials.”

direct quote[Code availability section]

“The code for the statistical analysis is available from C.A.R. and has been uploaded to GitHub ( https://github.com/caarhodes/Purrble ).”

The trial is registered at ClinicalTrials.gov (NCT06025942), and the registration number is provided. The paper states it was developed in accordance with the CONSORT 2010 checklist. All pre-specified outcomes are reported, including null results for self-harm. Limitations are explicitly discussed in a dedicated section. Conclusions are generally proportional, acknowledging the need for replication and the post-hoc nature of subgroup analyses. Funding sources and competing interests are declared.

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineADEQUATE

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 90% conf

The paper is transparently reported with a trial registration, reference to CONSORT, discussion of limitations, and proportional conclusions, though the trial registration number is only in the abstract and data statement.

Evidence

direct quote[Abstract; Methods, Trial design and ethical approval]

“ClinicalTrials.gov: NCT06025942”

direct quote[Methods, Trial design and ethical approval]

“This paper was developed in accordance with the CONSORT 2010 checklist”

direct quote[Discussion, paragraph 5]

“Results should be interpreted in the context of several limitations.”

PASSReviewer 2· 90% conf

The paper is well-reported with a trial registration, adherence to CONSORT, discussion of limitations, and proportional conclusions, though a formal reporting checklist is not explicitly submitted.

Evidence

direct quote[Abstract]

“ClinicalTrials.gov: NCT06025942”

direct quote[Methods, Trial design and ethical approval]

“This paper was developed in accordance with the CONSORT 2010 checklist”

direct quote[Discussion, paragraph 6]

“Results should be interpreted in the context of several limitations.”

PASSReviewer 3· 90% conf

The manuscript demonstrates high reporting transparency with a clinical trial registration, a CONSORT diagram, detailed methods, limitations discussion, proportional conclusions, and clear funding/COI statements.

Evidence

direct quote[Abstract, Methods]

“ClinicalTrials.gov: NCT06025942 (http://clinicaltrials.gov/study/NCT06025942)”

direct quote[Methods, Trial design and ethical approval]

“This paper was developed in accordance with the CONSORT 2010 checklist”

direct quote[Discussion, paragraphs 6-7]

“Results should be interpreted in the context of several limitations. First, our design compared Purrble plus safety planning with safety planning alone...”

6 copyedit issues flagged: mostly consistency, clarity.

Reproducibility

6 data/code links checked; 4 live, 1 dead.

Registered (1 ID: ClinicalTrials.gov). Reporting guideline cited: CONSORT.

Full text (93,448 chars · analyzed ~80%, head + tail)Analyzed: Jul 7, 2026

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