Tag: Clinical trial

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A Smartphone-Based Acoustic Machine Learning Pipeline for Detecting Suicidal Ideation: Case-Control Model Development and Validation Study

Background: Suicidal ideation (SI) among university students is a growing public health concern. Self-report screening can be limited by concealment and delayed disclosure. We evaluated a leakage-resistant, proof-of-concept pipeline to detect SI from standardized smartphone-recorded speech. Objective: This study aimed to extract acoustic markers from brief smartphone-based reading tasks and develop machine learning models for suicide risk prediction in university students, enabling low-cost, scalable early screening to support campus mental health services. Methods: Questionnaire data and speech recordings were collected via a WeChat mini program. After screening and clinical confirmation, 96 participants (n=48, 50% with SI; n=48, 50% controls) were included. Age and sex were evaluated as potential confounders. Each participant read 16 standardized sentences. Acoustic features were extracted using openSMILE (version 3.0.2), yielding a 570D feature vector per utterance. To prevent leakage from multiple recordings per speaker, we used participant-level 5-fold cross-validation, assigning all recordings from each participant to a single fold. Seven machine learning algorithms were evaluated using area under the curve (AUC), accuracy, and -score. Results: Acoustic-based models discriminated participants with SI from control participants. The SI group was significantly older than the control group (=.001). Random forest achieved an AUC of 0.813 (accuracy=0.748), and naive Bayes achieved an AUC of 0.806 (accuracy=0.757). Feature families related to pitch, mel-frequency cepstral coefficients, and harmonicity contributed to model performance. Conclusions: Standardized read speech captured via smartphones shows preliminary feasibility for SI discrimination under a leakage-aware evaluation design. External validation and testing with more naturalistic speech are warranted. Trial Registration: Chinese Clinical Trial Registry ChiCTR2500106625; https://www.chictr.org.cn/showproj.html?proj=276927
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Improving family functioning and wellbeing among families of children with disabilities in Rwanda: an application of the SAFE child protection model

BackgroundFamilies of children with disabilities in low-resource settings face heightened challenges to family functioning and wellbeing. Improving a child and caregiver’s environment in these settings requires a broader understanding of the family ecosystem. This study aims to investigate factors that should be considered to enhance family functioning and inform family-centered interventions.MethodologyWe conducted 34 in-depth interviews with 30 caregivers of children with disabilities aged 6–8 years enrolled in a larger cluster randomized trial of the Sugira Muryango parenting intervention. Additionally, six focus group discussions were conducted with 36 community workers, and 6 Early Childhood Developmental (ECD) advocates participants. Guided by the SAFE Model for child protection, content analysis was used to understand threats to child protection and caregivers’ well-being among caregivers of children with disabilities enrolled in Sugira Muryango.ResultsConsistent with the domains outlined in the SAFE Model, our analysis revealed the following threats to child safety: 1) Safety/Freedom from harm, including father’s mental health and substance abuse, abandonment and stigma related to a child’s disability; 2) Access to basic physiological needs and healthcare, including lack of basic necessities (food, utilities and housing), additional needs related to caring for a child with disabilities, caregiver mental health needs, limited access to health insurance and mother illness; 3) Family and connection to others, including the single-parent dilemma, lack of support from family and community, and father abandonment; and 4) Education and economic security, including additional expenses due to the child’s disability and financial stress related to health care costs.ConclusionImproving family functioning and wellbeing among caregivers of children with disabilities in limited resources requires a deep understanding of socioecological forces operating on the family system. These findings provide further evidence of how the threats to child safety highlighted by the SAFE Model can inform how researchers, and policy makers design and implement family-centered interventions tailored to children with disabilities in low-resource settings.
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Ketogenic therapy as a potential novel treatment approach for PTSD: an integrative review and proposed mechanistic model

BackgroundBrain and body metabolic disruptions have been suggested in several studies as a mechanism underlying posttraumatic stress disorder (PTSD). Therapies targeting metabolic pathways might provide new treatment options. This review explores the potential of ketogenic therapies, such as the ketogenic diet and ketone supplementation, as novel metabolic treatments for PTSD.MethodsAn integrative review was conducted. We searched PubMed, Scopus, PsycINFO, PsycArticles, PSYNDEX, MEDLINE, ClinicalTrials.gov, International Clinical Trials Registry Platform, and EU Clinical Trials Register for clinical, preclinical, observational, mechanistic, and review studies that reported outcomes or mechanisms on the intersection of ketogenic therapy and PTSD. Methodological quality of included studies was assessed independently by two reviewers based on predefined criteria.ResultsSixteen articles (9 human, 4 animal studies, 3 reviews) were eligible and included in the present review. Several metabolic and signaling pathways through which ketogenic therapies could impact PTSD pathophysiology were identified. Preclinical data suggestive of potential efficacy were identified, while only minimal reliable information is available from human studies.DiscussionImportantly, the absence of larger clinical trials and the reliance on low-level evidence substantially limit current interpretations. High-quality randomized and adequately powered clinical trials are required to examine the potential role of ketogenic therapies in treating PTSD.
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Remotely Supervised, Home-Based Transcranial Direct Current Stimulation for Major Depressive Disorder: Systematic Review and Meta-Analysis

Background: Major depressive disorder affects over 280 million people worldwide, and access to effective treatment remains limited. Transcranial direct current stimulation (tDCS) is a noninvasive option, and portable devices now allow for home-based delivery under varying degrees of remote supervision. Objective: This study aimed to systematically review and meta-analyze the efficacy, safety, feasibility, and acceptability of home-based and remotely supervised tDCS for depressive disorders. Methods: Following the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) 2020 and PRISMA-S (Preferred Reporting Items for Systematic Reviews and Meta-Analyses literature search extension) guidelines, we searched MEDLINE, Embase, Web of Science, the Cochrane databases, ClinicalTrials.gov, and the World Health Organization International Clinical Trials Registry Platform up to July 2025, with backward and forward citation searching. Two reviewers independently screened records, extracted data, and assessed risk of bias (version 2 of the Cochrane risk-of-bias tool for randomized trials, Newcastle-Ottawa Scale for observational studies, and Critical Appraisal Skills Programme for qualitative studies) and certainty of evidence (Grading of Recommendations Assessment, Development, and Evaluation; GRADE). Results: This review included 12 distinct studies (16 reports), of which 6 (50%) were randomized sham-controlled trials forming the meta-analytic pool. Active home-based tDCS produced a small, statistically significant improvement over sham (pooled Hedges =0.36, 95% CI 0.06-0.66; =.03; =34.3%). The effect was not robust to removal of the single largest positive trial (omitting the one study from 2025: =0.39, 95% CI −0.12 to 0.91), and trial-level results were mixed: the 2 largest trials (one unsupervised [n=210] and one self-administered [n=141]) were negative on their primary depression outcomes, whereas the largest real-time supervised trial (n=174) was positive (between-group 95% CI 0.51‐4.01; =.01). This estimate was concordant in direction with an independent peer-reviewed meta-analysis of overlapping trials, which reported a pooled Montgomery-Åsberg Depression Rating Scale reduction (weighted mean difference −2.74, 95% CI −4.19 to −1.29) and Hamilton Depression Rating Scale reduction (weighted mean difference −2.24, 95% CI −4.16 to −1.49), attenuating to nonsignificance (>.05) in major depressive disorder without comorbid cognitive impairment. The pooled effect fell at or near the minimal clinically important difference. GRADE certainty was moderate. Adverse events were predominantly mild: one pilot study was terminated early for skin lesions, and one nonfatal suicide attempt occurred in an unsupervised trial. Conclusions: Home-based and remotely supervised tDCS produces a small, statistically significant but clinically modest antidepressant effect that is sensitive to the inclusion of the largest positive trial, with the 2 largest trials being negative. The available controlled evidence does not establish supervision intensity as a determinant of efficacy. Current data are insufficient to recommend routine clinical adoption; adequately powered trials with standardized supervision and longer follow-up are needed. Trial Registration: PROSPERO registration number CRD420251109275; https://www.crd.york.ac.uk/PROSPERO/view/CRD420251109275
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3-Dimensional Optical Scanning to Assess and Monitor Malnutrition in Eating Disorders (3D-ED) Study

Conditions: Anorexia in Adolescence; Anorexia Nervosa; Anorexia Nervosa, Atypical; Anorexia Nervosa, Binge Eating/Purging Type; Anorexia Nervosa Restricting Type; Anorexia Nervosa With Significantly Low Body Weight; Body Composition Changes; Growth & Development; Malnutrition Severe; Malnutrition, Calorie

Sponsors: University of California, San Francisco; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Denver Health and Hospital Authority; University of Hawaii

Not yet recruiting
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INTEGRATING EXPOSURE AND RESPONSE PREVENTION AND HABIT REVERSAL TECHNIQUES TO TREAT A TOURETTIC SUBTYPE OF OBSESSIVE-COMPULSIVE DISORDER (TOURETTIC OCD).

Conditions: Obsessive – Compulsive Disorder; Tic Disorder, Chronic Motor or Vocal; Tic Disorders; Tic Disorder, Combined Vocal and Multiple Motor; Tourette Disease; Tourette Disorder; Tourettes Syndrome; Gilles de la Tourette Syndrome

Interventions: Behavioral: Exposure and Response Prevention (ERP); Behavioral: Habit Reversal Training (HbRT; Behavioral: Psychoeducation and Supportive Intervention

Sponsors: University College London Hospitals

Recruiting