NCT04751968

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 12, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

April 12, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 25, 2023

Completed
Last Updated

May 6, 2024

Status Verified

May 1, 2024

Enrollment Period

2.1 years

First QC Date

February 2, 2021

Last Update Submit

May 3, 2024

Conditions

Keywords

AdolescentSuicidal ideationGroup therapyCrisis

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 weeks

Secondary Outcomes (3)

  • Depression and Anxiety

    6 weeks

  • Attachment

    6 weeks

  • Family Functioning

    6 weeks

Study Arms (2)

Group Intervention

EXPERIMENTAL

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

Enhanced Treatment as Usual

OTHER

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

Interventions

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.

Group Intervention

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

Enhanced Treatment as Usual

Eligibility Criteria

Age13 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHEO

Ottawa, Ontario, K1H 8L1, Canada

Location

Related Publications (8)

  • 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.

    PMID: 30978144BACKGROUND
  • 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.

    PMID: 10937431BACKGROUND
  • Reynolds, W. M. (1988). Suicidal Ideation Questionnaire Professional Manual (p. 47).

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 19766302BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 22826567BACKGROUND
  • Kennedy A, Gray C, Sheridan N, Dunn L, Stewart J, Drouin S, Elliott H, Adeponle A, Barrowman N, Sucha E, Cappelli M, Norris ML, Jabbour M, Cloutier P. BRAVA: A randomized controlled trial of a brief group intervention for youth with suicidal ideation and their caregivers. Child Adolesc Psychiatry Ment Health. 2025 Jul 16;19(1):78. doi: 10.1186/s13034-025-00941-1.

Related Links

MeSH Terms

Conditions

Suicidal IdeationSuicideSelf-Injurious Behavior

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Allison Kennedy, PhD

    CHEO

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 2, 2021

First Posted

February 12, 2021

Study Start

April 12, 2021

Primary Completion

May 25, 2023

Study Completion

August 25, 2023

Last Updated

May 6, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations