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Suicide, AttemptedNCT06474221

Efficacy of EBPSI on Future Suicide Risk Among Adolescent Suicide Attempters

A study testing Electronic Based Psychosocial Intervention (EBPSI) in people with Suicide, Attempted, run by University of Pittsburgh at 2 sites in India.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 12 to 18 years
Conditions the study is for
Suicide, Attempted
What is being tested?
Electronic Based Psychosocial Intervention (EBPSI)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
168 participants
Where
2 sitesIndia
Study dates
31 Aug 2024to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Vishwajit L Nimgaonkar, MD, PhD contact

4127265164

vishwajitnl@upmc.edu

Triptish Triptish, PhD contact

+919910107210

trb16@pitt.edu

India2 sites, 2 recruiting
  • St John's Medical College and Hospital

    Bengaluru, Karnataka, 560034

    Suhas Chandran, MD, +919916455073, suhaschandran90@gmail.com

    Priya Sreedaran, MD, +919916043454, drpriyasreedaran@gmail.com

    Recruiting
  • Kalinga Institute of Medical Sciences (KIMS),

    Bhubaneswar, Odisha, 751024

    Jigyansa I Pattnaik, MD, +918093515161, drjigyansaipsita@gmail.com

    Priya Sreedaran, MD, +919916043454, drpriyasreedaran@gmail.com

    Recruiting

Other trials in India

About this study

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

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.

Read the 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.
  1. 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.
  1. 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).
  2. 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.
  3. 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..
  1. 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.

Being tested
Electronic Based Psychosocial Intervention (EBPSI)
Keywords
Suicide attempt, Electronic Based Psychosocal Intervention(EBPSI)
Medical subject headings
Suicide, Attempted

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Electronic Based Psychosocial Intervention (EBPSI)Behavioural

    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.

Study groups in NCT06474221
Study groupRoleWhat they receive
Electronic Based Psychosocial Intervention (EBPSI)ExperimentalElectronic 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.
Receives: Behavioral: Electronic Based Psychosocial Intervention (EBPSI)
Treatment as UsualActive comparatorThe 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.
Receives: Behavioral: Electronic Based Psychosocial Intervention (EBPSI)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

Secondary outcomes (5)
  1. Depression

    Change in depression in intervention group as compared to TAU using Beck Depression Inventory (BDI). The minimum score is 0 and maximum is 63.

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

  2. Acceptability of Intervention Measure (AIM)

    To assess the acceptability of EBPSI By using acceptability of Intervention Measure and Intervention Appropriateness Measure (IAM). The minimum score is 0 and maximum is 16.

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

  3. Feasibility of Intervention Measure (FIM)

    To assess the feasibility of intervention by using Feasibility of Intervention Measure (FIM). The minimum score is 0 and maximum is 16.

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

  4. Attribution Style

    To compare change in attribution styles of intervention and TAU group using Children's Attributional Style Questionnaire (Minimum score 5 and maximum score is 35).

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

  5. Coping Mechanism

    To study the change in coping mechanism in intervention group as compared to TAU using BRIEF - COPE - Brief Coping Questionnaire. Each strategy is scored separately and minimum score is 1 and maximum score is 8.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2024
  2. Study start31 Aug 2024
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
168 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06474221
Sponsor's protocol ID
STUDY23010001
Other IDs
5D43TW009114-10
Status last verified
Apr 2026
First submitted
18 Jun 2024
Last updated
7 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data that underlie the results reported in the article, after deidentification (text, tables, figures, and appendices).

Questions about this trial

What is this clinical trial studying?

A study testing Electronic Based Psychosocial Intervention (EBPSI) in people with Suicide, Attempted, run by University of Pittsburgh at 2 sites in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Vishwajit L Nimgaonkar, MD, PhD (4127265164, vishwajitnl@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Persistent Suicide Ideation (time frame: At baseline and 1,3, 6 and 12 months after the baseline intervention.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.

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