BRAVA: Building Resilience and Attachment in Vulnerable Adolescents

Sponsor
Children's Hospital of Eastern Ontario (Other)
Overall Status
Recruiting
CT.gov ID
NCT04751968
Collaborator
Mach Gaensslen Foundation (Other), Children's Hospital of Eastern Ontario Research Institute (Other)
98
1
2
21.7
4.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Group Intervention
  • Behavioral: Enhanced Treatment as Usual
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
98 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Apr 12, 2021
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Feb 1, 2023

Arms and Interventions

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.

Other: 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.

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.

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

  1. Suicidal Ideation [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.

Secondary Outcome Measures

  1. Depression and Anxiety [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.

  2. Attachment [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.

  3. Family Functioning [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
13 Years to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHEO Ottawa Ontario Canada K1H 8L1

Sponsors and Collaborators

  • Children's Hospital of Eastern Ontario
  • Mach Gaensslen Foundation
  • Children's Hospital of Eastern Ontario Research Institute

Investigators

  • Principal Investigator: Allison Kennedy, PhD, CHEO

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Allison Kennedy, Principal Investigator, Children's Hospital of Eastern Ontario
ClinicalTrials.gov Identifier:
NCT04751968
Other Study ID Numbers:
  • 1922_SI_Group
First Posted:
Feb 12, 2021
Last Update Posted:
Jul 26, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Allison Kennedy, Principal Investigator, Children's Hospital of Eastern Ontario
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 26, 2022