Ignite Creation Date:
2024-07-17 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06474221
Status:
RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-06-18
Brief Title:
Efficacy of EBPSI on Future Suicide Risk Among Adolescent Suicide Attempters
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
A Multi-centric Trial to Evaluate the Efficacy of Electronic-Based Psychosocial Interventions on Future Suicide Risk Among Adolescent Suicide Attempters
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 MINI KID 60 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 Childrens 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 11 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 interventioncoping 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 Childrens 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 13 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
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 MINI KID 60 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 Childrens 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 11 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 interventioncoping 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 Childrens 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 13 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| D43TW009114 | NIH | None | None |