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.
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)
- Type of treatment
- Lifestyle or therapy programme
- 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.
India2 sites, 2 recruiting
- 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
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:
- Screening to establish eligibility for the study
- Obtaining Consent
- Baseline Assessment
- Randomisation
- Intervention
- Follow up and Assessments
Detailed description of each activity:
- 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.
- 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.
- 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).
- 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.
- 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..
- 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
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Electronic Based Psychosocial Intervention (EBPSI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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)
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.
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.
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.
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.
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.
- First posted25 Jun 2024
- Study start31 Aug 2024
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicide, AttemptedStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health, St.John's Medical College and Hospital
- Responsible party
- Principal investigator, Vishwajit Nimgaonkar, MD PhD, University of Pittsburgh
- Investigators
- Vishwajit L Nimgaonkar, MD, PhD, Principal investigator, University of Pittsburgh
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).
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centric Trial to Evaluate the Efficacy of Electronic-Based Psychosocial Interventions on Future Suicide Risk Among Adolescent Suicide Attempters
- ClinicalTrials.gov ID
- NCT06474221
- Acronym / sponsor ID
- STUDY23010001
- Conditions
- Suicide, Attempted
- Keywords
- Suicide attempt, Electronic Based Psychosocal Intervention(EBPSI)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health, St.John's Medical College and Hospital
- Study start
- 31 Aug 2024 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 25 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Screening to establish eligibility for the study
- Obtaining Consent
- Baseline Assessment
- Randomisation
- Intervention
- Follow up and Assessments
Detailed description of each activity:
- 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.
- 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.
- 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).
- 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.
- 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..
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Electronic Based Psychosocial Intervention (EBPSI) | Experimental | Behavioral: Electronic Based Psychosocial Intervention (EBPSI)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. |
| Treatment as Usual | Active comparator | Behavioral: Electronic Based Psychosocial Intervention (EBPSI)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. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Electronic Based Psychosocial Intervention (EBPSI), Treatment as Usual |
Primary outcome
Persistent Suicide Ideation
Time frame: At baseline and 1,3, 6 and 12 months after the baseline intervention.
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.
Suicide attempts
Time frame: At baseline and 1,3, 6 and 12 months after the baseline intervention.
Change in intervention arm as compared to TAU on number of suicide attempts. Minimum attempts can be 0 and maximum can be infinity.
5 secondary outcomes
Depression
Time frame: At baseline and 1,3, 6 and 12 months after the baseline intervention.
Acceptability of Intervention Measure (AIM)
Time frame: At baseline and 1,3, 6 and 12 months after the baseline intervention.
Feasibility of Intervention Measure (FIM)
Time frame: At baseline and 1,3, 6 and 12 months after the baseline intervention.
Attribution Style
Time frame: At baseline and 1,3, 6 and 12 months after the baseline intervention.
Coping Mechanism
Time frame: At baseline and 1,3, 6 and 12 months after the baseline intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in the article, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vishwajit L Nimgaonkar, MD, PhD principal investigator
University of Pittsburgh
2 sites in 1 country: see every site and its status.
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.