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BRAVA: Building Resilience and Attachment in Vulnerable Adolescents (BRAVA)

Primary Purpose

Suicidal Ideation, Suicide and Self-harm

Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Group Intervention
Enhanced Treatment as Usual
Sponsored by
Children's Hospital of Eastern Ontario
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Suicidal Ideation focused on measuring Adolescent, Suicidal ideation, Group therapy, Crisis

Eligibility Criteria

13 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHEO

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Group Intervention

Enhanced Treatment as Usual

Arm Description

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.

Youth and Caregivers will receive a weekly text message reminder of their exit assessment date/time, a mental health tip and crisis resources.

Outcomes

Primary Outcome Measures

Suicidal Ideation
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.

Secondary Outcome Measures

Depression and Anxiety
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.
Attachment
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.
Family Functioning
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.

Full Information

First Posted
February 2, 2021
Last Updated
May 1, 2023
Sponsor
Children's Hospital of Eastern Ontario
Collaborators
Mach Gaensslen Foundation, Children's Hospital of Eastern Ontario Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04751968
Brief Title
BRAVA: Building Resilience and Attachment in Vulnerable Adolescents
Acronym
BRAVA
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 12, 2021 (Actual)
Primary Completion Date
May 25, 2023 (Anticipated)
Study Completion Date
August 25, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Hospital of Eastern Ontario
Collaborators
Mach Gaensslen Foundation, Children's Hospital of Eastern Ontario Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicidal Ideation, Suicide and Self-harm
Keywords
Adolescent, Suicidal ideation, Group therapy, Crisis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
99 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Enhanced Treatment as Usual
Arm Type
Other
Arm Description
Youth and Caregivers will receive a weekly text message reminder of their exit assessment date/time, a mental health tip and crisis resources.
Intervention Type
Other
Intervention Name(s)
Group Intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Treatment as Usual
Intervention Description
Youth and Caregivers will receive a weekly text message reminder of their exit assessment date/time, a mental health tip and crisis resources.
Primary Outcome Measure Information:
Title
Suicidal Ideation
Description
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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Depression and Anxiety
Description
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.
Time Frame
6 weeks
Title
Attachment
Description
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.
Time Frame
6 weeks
Title
Family Functioning
Description
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.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allison Kennedy, PhD
Organizational Affiliation
CHEO
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHEO
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30978144
Citation
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.
Results Reference
background
PubMed Identifier
10937431
Citation
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.
Results Reference
background
Citation
Reynolds, W. M. (1988). Suicidal Ideation Questionnaire Professional Manual (p. 47).
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
19766302
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
22826567
Citation
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.
Results Reference
background
Links:
URL
http://www.cheoresearch.ca
Description
CHEO Research Institute

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BRAVA: Building Resilience and Attachment in Vulnerable Adolescents

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