Efficacy of EBPSI on Future Suicide Risk Among Adolescent Suicide Attempters

NCT06474221 | Recruiting

• 2 other identifiers: STUDY230100015D43TW009114-10
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Suicide, Attempted

Keywords

Suicide attempt; Electronic Based Psychosocal Intervention(EBPSI)

Outcome Measures

Primary Outcomes (2)

• Persistent Suicide Ideation

  Change in intervention arm as compared to TAU on persistent suicidal ideation using the Columbia Suicide Severity Rating Scale (C-SSRS). the ideation ranges from 0-5 on this scale.

  At baseline and 1,3, 6 and 12 months after the baseline intervention.

• Suicide attempts

  Change in intervention arm as compared to TAU on number of suicide attempts. Minimum attempts can be 0 and maximum can be infinity.

  At baseline and 1,3, 6 and 12 months after the baseline intervention.

Secondary Outcomes (5)

• Depression

  At baseline and 1,3, 6 and 12 months after the baseline intervention.

• Acceptability of Intervention Measure (AIM)

  At baseline and 1,3, 6 and 12 months after the baseline intervention.

• Feasibility of Intervention Measure (FIM)

  At baseline and 1,3, 6 and 12 months after the baseline intervention.

• Attribution Style

  At baseline and 1,3, 6 and 12 months after the baseline intervention.

• Coping Mechanism

  At baseline and 1,3, 6 and 12 months after the baseline intervention.

Study Arms (2)

Electronic Based Psychosocial Intervention (EBPSI)

EXPERIMENTAL

Electronic Based Psychosocial 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.

Behavioral: Electronic Based Psychosocial Intervention (EBPSI)

Treatment as Usual

ACTIVE COMPARATOR

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 session shall include a reminder for the next planned follow up session and a general query for overall wellbeing.

Behavioral: Electronic Based Psychosocial Intervention (EBPSI)

Interventions

Electronic Based Psychosocial Intervention (EBPSI) BEHAVIORAL

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.

Electronic Based Psychosocial Intervention (EBPSI); Treatment as Usual

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• All adolescents who have attempted suicide within the last thirty days and presented to the study site
• Between ages of 12-18 years
• Participants of all gender will be included
• Medically stable patients who have stable blood pressure, breathing rates without fever, and intact orientation to time, place, and person

You may not qualify if:

• A current or a lifetime diagnosis of psychosis. We will confirm the same using a detailed clinical interview according to ICD-10 diagnostic guidelines.
• A history of mental retardation and any neurological condition causing cognitive impairment.
• A diagnosis of substance dependence as confirmed by M.I.N.I. KID 6.0 over the last six months. We will include those with tobacco dependence.
• A diagnosis of serious medical illness like end-stage cancer, AIDS, less than a month following acute cardiovascular and cerebrovascular events.

Sponsors & Collaborators

• Fogarty International Center of the National Institute of Health: collaborator
• University of Pittsburgh: lead
• St.John's Medical College and Hospital: collaborator

Study Sites (2)

St John's Medical College and Hospital

Bengaluru, Karnataka, 560034, India

RECRUITING

Kalinga Institute of Medical Sciences (KIMS),

Bhubaneswar, Odisha, 751024, India

RECRUITING

MeSH Terms

Conditions

Suicide, Attempted

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Vishwajit L Nimgaonkar, MD, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vishwajit L Nimgaonkar, MD, PhD

CONTACT

4127265164; vishwajitnl@upmc.edu

Triptish Triptish, PhD

CONTACT

+919910107210; trb16@pitt.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The rater will be blind to the group status of the participant.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This is a multicentric, parallel arm, interventional randomized control trial. A total of 84 at each site will be enrolled, N = 168 would be adequate for both sites together.

Study Record Dates

• First Submitted: June 18, 2024
• First Posted: June 25, 2024
• Study Start: August 31, 2024
• Primary Completion: March 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: One year after publication of the results of the study.
• Access Criteria: For individual participant data, meta-analysis.

Locations

IN (2)