NCT06474221

Efficacy of EBPSI on Future Suicide Risk Among Adolescent Suicide Attempters

A Multi-centric Trial to Evaluate the Efficacy of Electronic-Based Psychosocial Interventions on Future Suicide Risk Among Adolescent Suicide Attempters

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 168 (estimated)
• Sponsor: University of Pittsburgh · Academic / Other
• Sex: All
• Age: 12 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

Our study is designed to study the efficacy of an Electronic based psycho-social intervention targeting healthy coping and problem solving skills to mitigate suicidal behaviour. This would integrate existing systems and bridge the gap in accessibility to care for suicidal behaviour.

Detailed description

The investigators shall be performing the following Research Activities: 1. Screening to establish eligibility for the study 2. Obtaining Consent 3. Baseline Assessment 4. Randomisation 5. Intervention 6. Follow up and Assessments Detailed description of each activity: 1. Screening to establish eligibility for the study * All adolescents with an episode of Deliberate Self Harm within the last one month: who present to the hospital in the Emergency / Casualty; Pediatric Out patient (OPD) / Pediatric in Patient (IPD), Medicine Out patient (OPD) / Medicine in Patient (IPD), Psychiatric in-patient/ Psychiatric Out-Patient units; shall be screened for the eligibility into the study. * The adolescents who screen positive for Psychosis (as per the criteria for any psychotic disorder under ICD-10- F20 to F29) shall be excluded. * The adolescents who screen positive for substance dependence (as per the M.I.N.I. KID 6.0) for any substance except nicotine shall be excluded from the study. 2. Obtaining Consent • The eligible adolescents and their parents shall be provided with detailed information about the study as described in the patient information sheet, followed by provision of adequate time and oppurtunity for clarification and handed over a copy of the same for reference. Thereafter, verbal and written assent from the adolescent and informed consent from the parnets shall be obtained. 3. Baseline Assessment After assessing for eligibility and obtaining valid informed consent, baseline assessment shall be performed based on the pre-designed semi-structured questionnaire and the tools as stated above (which includes Beck Depression Inventory (BDI), Presumptive stressful life event scale (PSSI), Columbia Suicide Severity Rating Scale (C-SSRS), Children's Attributional Style Questionnaire, BRIEF - COPE - Brief Coping Questionnaire). 4. Randomizsation The investigators will allocate participants to either Electronic based Psycho-social Intervention (EBPSI) or Treatment As Usual (TAU) in 1:1 ratio using simple computerized block randomization in blocks of ten performed separately at each site. The randomization sequence will be performed by a study personnel who will not be involved either in delivery or evaluation of EBPSI and TAU. Investigators will remind participants during the evaluation process not to divulge contents of their phone conversations to prevent unblinding. 5. Intervention: The participants shall be divided into two groups after randomization. • One arm shall receive an Electronic based Psycho-social Intervention (EBPSI) described as video based telepsychiatry sessions targeted on brief intervention and coping skills; with a total of 5 sessions on days 10, 30, 45, 60 and 90 after baseline intervention. The video-based telepsychiatry consultations shall include a total of 5 sessions on days 10, 30, 45, 60 and 90 after baseline intervention. The content would focus on brief interventions and coping skills. These are already discussed with mentors, study team at Pittsburgh. One typical session shall include three parts: the first is an introduction/ recap for initial 5 to 10 mins, followed by a discussion on brief intervention/coping skills for the next 15 to 20 minutes and conclude by summarizing for 5 to 10 minutes. • The Treatment as Usual (TAU) arm shall be a telephonic regular contact: with a total of 5 reminder calls on days 10, 30, 45, 60 and 90 after baseline intervention (the same frequency as the Intervention-Arm including video-based sessions). The session shall include a reminder for the next planned follow-up session and a general query for overall wellbeing. The sessions will be based on the Supportive psychotherapy framework primarily focusing on providing emotional support, encouragement, and validation during difficult life circumstances or psychological challenges.. 6. Follow up and Assessments The Rater shall be blind to participant allocation and follow up assessements (which includes Beck Depression Inventory (BDI), Presumptive stressful life event scale (PSSI), Columbia Suicide Severity Rating Scale (C-SSRS), Children's Attributional Style Questionnaire, BRIEF - COPE - Brief Coping Questionnaire, Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), Feasibility of Intervention Measure (FIM)) shall happen at 1,3, 6 and 12 months after the baseline intervention. Study team at Pittsburgh will keep checking online the number of recruitment, keep discussing the progress and challenges during following the protocol. They will also keep asking regarding consent forms and whether they are signed by them. The deidentified data will be shared with Pitt team and they will check whether administration of scales and data entry and collection are appropriately carried out.

Conditions

• Suicide, Attempted

Interventions

Type	Name	Description
BEHAVIORAL	Electronic Based Psychosocial Intervention (EBPSI)	Electronic based Psycho-social Intervention (EBPSI) described as video based telepsychiatry sessions targeted on brief intervention and coping skills; with a total of 5 sessions on days 10, 30, 45, 60 and 90 after baseline intervention.

Timeline

• Start date: 2024-08-31
• Primary completion: 2026-09-30
• Completion: 2026-12-31
• First posted: 2024-06-25
• Last updated: 2026-04-07

Locations

2 sites across 1 country: India