BRAVA: Building Resilience and Attachment in Vulnerable Adolescents

NCT ID: NCT04751968

Last Updated: 2024-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-12

Study Completion Date

2023-08-25

Brief Summary

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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.

Detailed Description

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Conditions

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Suicidal Ideation Suicide and Self-harm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Group Intervention

Intervention Type 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

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

Group Type OTHER

Enhanced Treatment as Usual

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

13 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mach Gaensslen Foundation

OTHER

Sponsor Role collaborator

Children's Hospital of Eastern Ontario Research Institute

OTHER

Sponsor Role collaborator

Children's Hospital of Eastern Ontario

OTHER

Sponsor Role lead

Responsible Party

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Allison Kennedy

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Allison Kennedy, PhD

Role: PRINCIPAL_INVESTIGATOR

CHEO

Locations

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CHEO

Ottawa, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type BACKGROUND
PMID: 30978144 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10937431 (View on PubMed)

Reynolds, W. M. (1988). Suicidal Ideation Questionnaire Professional Manual (p. 47).

Reference Type 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.

Reference Type 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.

Reference Type BACKGROUND
PMID: 19766302 (View on PubMed)

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.

Reference Type 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.

Reference Type BACKGROUND
PMID: 22826567 (View on PubMed)

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.

Reference Type DERIVED
PMID: 40671103 (View on PubMed)

Related Links

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http://www.cheoresearch.ca

CHEO Research Institute

Other Identifiers

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1922_SI_Group

Identifier Type: -

Identifier Source: org_study_id

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