Clinical trial NCT04751968: BRAVA: Building Resilience and Attachment in Vulnerable Adolescents
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicidal Ideation
Suicide and Self-harm
Keywords: Adolescent
Suicidal ideation
Group therapy
Crisis
Lead sponsor: Children's Hospital of Eastern Ontario
Sponsor class: OTHER
Collaborators: name: Mach Gaensslen Foundation
name: Children's Hospital of Eastern Ontario Research Institute
First posted: 2021-02-12
Enrollment: 99
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Suicidal Ideation
timeFrame: 6 weeks
Secondary outcomes:
measure: Depression and Anxiety
timeFrame: 6 weeks
measure: Attachment
timeFrame: 6 weeks
measure: Family Functioning
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: CHEO
state: Ontario
Study officials:
affiliation: CHEO
name: Allison Kennedy, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: Reynolds, W. M. (1988). Suicidal Ideation Questionnaire Professional Manual (p. 47).
citation: 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.
citation: 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.
citation: 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.
citation: 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.