- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04751968
BRAVA: Building Resilience and Attachment in Vulnerable Adolescents (BRAVA)
May 1, 2023 updated by: Allison Kennedy, Children's Hospital of Eastern Ontario
Building Resilience and Attachment in Vulnerable Adolescents (BRAVA): A Randomized Controlled Trial of a Brief Group Intervention for Adolescents With Mild to Moderate Suicidal Ideation and Their Caregivers
The prevalence of suicidal ideation (SI) among adolescents in North America is high, making it critical to develop evidence-based brief interventions for adolescents with SI that target healthy coping skills and relationships.
BRAVA is a novel brief group intervention for adolescents with mild to moderate SI and their caregivers; youth are taught skills for coping and relating more effectively with others.
Caregivers learn about adolescent development, effective parenting and the importance of connection.
The goal of the randomized controlled trial is to assess the efficacy of a virtually-delivered, brief group intervention for adolescents with mild to moderate SI and their caregivers in reducing SI.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
99
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Allison Kennedy, PhD
- Phone Number: 613-737-7600
- Email: akennedy@cheo.on.ca
Study Locations
-
-
Ontario
-
Ottawa, Ontario, Canada, K1H 8L1
- CHEO
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years to 17 years (Child)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Adolescents 13 years old to 17.5 years old
- Mild to moderate suicidal ideation (SI without plan or gesture; 1 on the HEADS-ED) (Cappelli, et al., 2012)
- Interested in study participation
- Access to an electronic device with internet and email capabilities, and a functioning camera and microphone
Exclusion Criteria:
- SI with plan or gesture (2 on HEADS ED; indicated plan or gesture)
- Comorbid disorders (psychosis, schizophrenia, developmental disabilities, major substance abuse, and severe eating disorders).
- Referring clinician has identified an externalizing disorder as a primary diagnosis or primary concern (e.g. Conduct Disorder)
- Currently participating in regular psychotherapy at least one time per week
- Currently under Children's Aid Society care
- Currently in the CHEO ED on a Form 1 or Form 2, or placed on a Section 17.
- Express difficulty with reading and writing
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel 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.
Adolescents are taught skills for coping and relating more effectively with others.
Caregivers learn about adolescent development, effective parenting and the importance of connection.
The groups consist of 6 stand-alone modules permitting rolling entry and prompt access.
Youth and Caregivers will receive a weekly text message reminder of their exit assessment date/time, homework from that week's intervention group and crisis resources.
|
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.
Adolescents are taught skills for coping and relating more effectively with others.
Caregivers learn about adolescent development, effective parenting and the importance of connection.
The groups consist of 6 stand-alone modules permitting rolling entry and prompt access.
Youth and Caregivers will receive a weekly text message reminder of their exit assessment date/time, homework from that week's intervention group and crisis resources.
|
Other: Enhanced Treatment as Usual
Youth and Caregivers will receive a weekly text message reminder of their exit assessment date/time, a mental health tip and crisis resources.
|
Youth and Caregivers will receive a weekly text message reminder of their exit assessment date/time, a mental health tip and crisis resources.
|
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 (Reynolds, 1988).
A decreased score in suicidal ideation over 6-weeks will indicate a positive outcome.
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Depression and Anxiety
Time Frame: 6 weeks
|
We will be assessing youth depression and anxiety with the youth version of the Revised Child Anxiety and Depression Scale (Chorpita et al., 2000).
A decreased score in depression and anxiety over 6-weeks will indicate a positive outcome.
|
6 weeks
|
Attachment
Time Frame: 6 weeks
|
We will be assessing caregiver attachment with the adolescent version of the Adolescent Attachment Anxiety & Avoidance Inventory (Morretti & Obsuth, 2009).
A decreased score in attachment between the adolescent and caregiver over 6-weeks will indicate a positive outcome.
|
6 weeks
|
Family Functioning
Time Frame: 6 weeks
|
Family functioning using the Family Assessment Device (Epstein, Baldwin, & Bishop, 1983).
A decreased score in family functioning over 6-weeks will indicate a positive outcome.
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Chorpita BF, Yim L, Moffitt C, Umemoto LA, Francis SE. Assessment of symptoms of DSM-IV anxiety and depression in children: a revised child anxiety and depression scale. Behav Res Ther. 2000 Aug;38(8):835-55. doi: 10.1016/s0005-7967(99)00130-8.
- Cappelli M, Gray C, Zemek R, Cloutier P, Kennedy A, Glennie E, Doucet G, Lyons JS. The HEADS-ED: a rapid mental health screening tool for pediatric patients in the emergency department. Pediatrics. 2012 Aug;130(2):e321-7. doi: 10.1542/peds.2011-3798. Epub 2012 Jul 23.
- Epstein, N. B., Baldwin, L. M., & Bishop, D. S. (1983). The McMaster Family Assessment Device. Journal of Marital and Family Therapy, 9(2), 171-180.
- Reynolds, W. M. (1988). Suicidal Ideation Questionnaire Professional Manual (p. 47).
- Georgiades K, Boylan K, Duncan L, Wang L, Colman I, Rhodes AE, Bennett K, Comeau J, Manion I, Boyle MH; 2014 Ontario Child Health Study Team. Prevalence and Correlates of Youth Suicidal Ideation and Attempts: Evidence from the 2014 Ontario Child Health Study. Can J Psychiatry. 2019 Apr;64(4):265-274. doi: 10.1177/0706743719830031.
- Cloutier, P., Glennie, E., Kennedy, A., & Gray, C. (2009). Coping Behaviours and Non-Suicidal Self-Harm in Youth. In Canadian Psychological Association's 70th Annual Convention. Montreal, Quebec.
- Moretti MM, Obsuth I. Effectiveness of an attachment-focused manualized intervention for parents of teens at risk for aggressive behaviour: The Connect Program. J Adolesc. 2009 Dec;32(6):1347-57. doi: 10.1016/j.adolescence.2009.07.013. Epub 2009 Sep 18.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 12, 2021
Primary Completion (Anticipated)
May 25, 2023
Study Completion (Anticipated)
August 25, 2023
Study Registration Dates
First Submitted
February 2, 2021
First Submitted That Met QC Criteria
February 10, 2021
First Posted (Actual)
February 12, 2021
Study Record Updates
Last Update Posted (Actual)
May 3, 2023
Last Update Submitted That Met QC Criteria
May 1, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1922_SI_Group
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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