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Suicidal IdeationBRAVANCT04751968

BRAVA: Building Resilience and Attachment in Vulnerable Adolescents

A study testing Group Intervention and Enhanced Treatment as Usual in people with Suicidal Ideation and Suicide and Self-harm, run by Children's Hospital of Eastern Ontario at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 13 to 17 years
Conditions the study is for
Suicidal Ideation, Suicide and Self-harm
What is being tested?
Group Intervention and Enhanced Treatment as Usual
Could I receive a placebo?
No, everyone receives an active treatment
How many people
99 participants
Where
1 siteCanada
Study dates
12 Apr 2021to 25 Aug 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • CHEO

    Ottawa, Ontario, K1H 8L1

Other trials in Canada

About this study

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

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.

Being tested
Group Intervention, Enhanced Treatment as Usual
Keywords
Adolescent, Suicidal ideation, Group therapy, Crisis
Medical subject headings
Suicidal Ideation, Suicide, Self-Injurious Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Group InterventionOther

    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 UsualBehavioural

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

Study groups in NCT04751968
Study groupRoleWhat they receive
Group InterventionExperimentalThe 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.
Receives: Other: Group Intervention
Enhanced Treatment as UsualOtherYouth and Caregivers will receive a weekly text message reminder of their exit assessment date/time, a mental health tip and crisis resources.
Receives: Behavioral: Enhanced Treatment as Usual

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 weeks

Secondary outcomes (3)

  1. 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.

    Measured: 6 weeks

  2. 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.

    Measured: 6 weeks

  3. 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.

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2021
  2. Study start12 Apr 2021
  3. Primary completion25 May 2023
  4. Study completion25 Aug 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
99 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04751968
Sponsor's protocol ID
1922_SI_Group
Acronym
BRAVA
Status last verified
May 2024
First submitted
2 Feb 2021
Last updated
6 May 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 30978144

  • 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.

    PubMed 10937431

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

  • 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.

  • 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.

    PubMed 19766302

  • 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.

  • 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.

    PubMed 22826567

  • 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.

    PubMed 40671103

Questions about this trial

What is this clinical trial studying?

A study testing Group Intervention and Enhanced Treatment as Usual in people with Suicidal Ideation and Suicide and Self-harm, run by Children's Hospital of Eastern Ontario at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Suicidal Ideation (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04751968, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2024; AzTrials last refreshed its copy on 6 Nov 2026.

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