- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01925807
Building Resilience and Attachment in Vulnerable Adolescents (BRAVA)
Brief Group Intervention for Adolescents With Mild to Moderate Suicidal Ideation and Their Caregivers: Preliminary Investigation for a Novel Treatment Approach
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Ottawa, Ontario, Canada, K1H8L1
- Children's Hospital of Eastern Ontario
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Mild to moderate suicidal ideation
- Recently presented for services in response to a psycho-social crisis (Emergency Department, MH Urgent Care)
- One or two caregiver(s) committed to attending the majority of sessions
Exclusion Criteria:
- Presence of a suicidal plan and/or recent gesture/attempt
- Psychosis
- Schizophrenia
- Dual diagnosis
- Developmental disability or delay
- "Behavioural problem" as primary concern
- Major substance abuse
- Currently receiving mental health services (once every two weeks or more frequently)
- Inability to commit to majority of sessions (minimum 4 of 6 sessions)
- Children's aid society involvement
- Inability of at least one caregiver to commit to attending the majority of sessions
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group Intervention
The intervention will consist of 6 psycho-educational group sessions for caregivers and 6 psycho-educational group sessions for adolescents.
Adolescent and caregiver sessions will be held separately and will focus on different issues.
For adolescents, the group sessions will focus on coping strategies and emotional regulation.
For caregivers, the group sessions will be focused on attachment, family environment, and validation.
|
The intervention will consist of 6 psycho-educational group sessions for caregivers and 6 psycho-educational group sessions for adolescents.
Adolescent and caregiver sessions will be held separately and will focus on different issues.
For adolescents, the group sessions will focus on coping strategies and emotional regulation.
For caregivers, the group sessions will be focused on attachment, family environment, and validation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Suicidal Ideation
Time Frame: 6 weeks
|
Suicidal ideation will be measured using the Suicidal Ideation Questionnaire Junior (SIQ-JR; Reynolds, 1988). Repeated Measures ANOVA or ANCOVA will be used to compare differences in suicidal ideation within groups (pre-post changes). Further comparisons using clinical cut-off will be conducted via McNemar test for matched pairs. |
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Familial Support
Time Frame: 6 weeks
|
Familial support will be measured using questionnaires for both caregivers and youth. Youth will respond to the Family Environment Scale (Koren, DeChillo, & Friesen, 1992) and the Inventory of Parent and Peer Attachment (Armsden & Greenberg, 1987). Caregivers will respond to the Family Environment Scale and and Relationship Scale Questionnaire (Griffine & Gartholomew, 1994). Repeated Measures ANOVA or ANCOVA will be used to compare differences within groups (pre-post changes). |
6 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Coping Strategies
Time Frame: 6 weeks
|
Youth coping strategies will be measured using the Youth Stress and Coping Questionnaire (Cloutier et al., 2008). Repeated Measures ANOVA or ANCOVA will be used to compare differences within groups (pre-post changes). |
6 weeks
|
|
Depression
Time Frame: 6 weeks
|
Youth depression will be measured using the Children's Depression Inventory-2 Self report (CDI-2; Kovaks, 2010). Repeated Measures ANOVA or ANCOVA will be used to compare differences within groups (pre-post changes). |
6 weeks
|
|
Anxiety
Time Frame: 6 weeks
|
Youth anxiety symptoms will be measured using the Multidimensional Anxiety Scale for Children (MASC-2; March, 1997). Repeated Measures ANOVA or ANCOVA will be used to compare differences within groups (pre-post changes). |
6 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Allison Kennedy, Ph.D., Children's Hospital of Eastern Ontario
Publications and helpful links
General Publications
- Rathus JH, Miller AL. Dialectical behavior therapy adapted for suicidal adolescents. Suicide Life Threat Behav. 2002 Summer;32(2):146-57. doi: 10.1521/suli.32.2.146.24399.
- Diamond GS, Wintersteen MB, Brown GK, Diamond GM, Gallop R, Shelef K, Levy S. Attachment-based family therapy for adolescents with suicidal ideation: a randomized controlled trial. J Am Acad Child Adolesc Psychiatry. 2010 Feb;49(2):122-31. doi: 10.1097/00004583-201002000-00006.
- Armsden GC, Greenberg MT. The inventory of parent and peer attachment: Individual differences and their relationship to psychological well-being in adolescence. J Youth Adolesc. 1987 Oct;16(5):427-54. doi: 10.1007/BF02202939.
- Cloutier, P. F., Kennedy, A., & Glennie, E. (2008, June). Coping behaviors and intensity of non-suicidal self-harm in Canadian adolescents presenting to emergency mental health services. Poster presented at the third annual meeting of the International Society for the Study of Self-Injury (ISSS), Harvard University, Cambridge, MA.
- Kovacs, M. (2010). Children's Depression Inventory Manual. Toronto, ON: Multi-Health Systems Inc.
- March, J.S. (2013). Manual for the Multidimensional Anxiety Scale for Children - 2nd Edition (MASC-2). Toronto, ON: MHS Inc.
- Moos, R. H., & Moos, B. S. (1981). Family environment scale manual
- Reynolds, W. M. (1988). Suicidal Ideation Questionnaire Professional Manual (p. 47).
- Griffine, D. W., & Garthholomew, K. (1994). The metaphysics of measurement: The case of adult attachment. (pp. 17-52).
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHAMO_SI_Group_001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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