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OpenTrials
Completed

NCT Number: NCT04751968

BRAVA: Building Resilience and Attachment in Vulnerable Adolescents

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.

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Key information

Conditions

Suicidal Ideation Behavior Behavioral Symptoms Self-Injurious Behavior Suicide Suicide and Self-harm

Age range

13 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHEO

Ottawa, Ontario, K1H 8L1, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Group Intervention

Other

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.

Enhanced Treatment as Usual

Behavioral

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Children's Hospital of Eastern Ontario

Other

Collaborators

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

Registry information

Official study 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

Acronym: BRAVA

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 12, 2021
Registry last updated
May 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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