search
Back to results

Building Resilience and Attachment in Vulnerable Adolescents (BRAVA)

Primary Purpose

Suicidal Ideation

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Group Intervention
Sponsored by
Allison Kennedy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Suicidal Ideation focused on measuring Adolescent, Suicidal Ideation, Emergency Department, Crisis, Attachment, Coping

Eligibility Criteria

13 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Mild to moderate suicidal ideation
  • Recently presented for services in response to a psycho-social crisis (Emergency Department, MH Urgent Care)
  • One or two caregiver(s) committed to attending the majority of sessions

Exclusion Criteria:

  • Presence of a suicidal plan and/or recent gesture/attempt
  • Psychosis
  • Schizophrenia
  • Dual diagnosis
  • Developmental disability or delay
  • "Behavioural problem" as primary concern
  • Major substance abuse
  • Currently receiving mental health services (once every two weeks or more frequently)
  • Inability to commit to majority of sessions (minimum 4 of 6 sessions)
  • Children's aid society involvement
  • Inability of at least one caregiver to commit to attending the majority of sessions

Sites / Locations

  • Children's Hospital of Eastern Ontario

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Group Intervention

Arm Description

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. For adolescents, the group sessions will focus on coping strategies and emotional regulation. For caregivers, the group sessions will be focused on attachment, family environment, and validation.

Outcomes

Primary Outcome Measures

Suicidal Ideation
Suicidal ideation will be measured using the Suicidal Ideation Questionnaire Junior (SIQ-JR; Reynolds, 1988). Repeated Measures ANOVA or ANCOVA will be used to compare differences in suicidal ideation within groups (pre-post changes). Further comparisons using clinical cut-off will be conducted via McNemar test for matched pairs.

Secondary Outcome Measures

Familial Support
Familial support will be measured using questionnaires for both caregivers and youth. Youth will respond to the Family Environment Scale (Koren, DeChillo, & Friesen, 1992) and the Inventory of Parent and Peer Attachment (Armsden & Greenberg, 1987). Caregivers will respond to the Family Environment Scale and and Relationship Scale Questionnaire (Griffine & Gartholomew, 1994). Repeated Measures ANOVA or ANCOVA will be used to compare differences within groups (pre-post changes).

Full Information

First Posted
August 14, 2013
Last Updated
August 10, 2017
Sponsor
Allison Kennedy
Collaborators
Mach Gaensslen Foundation, AFP Innovation Fund
search

1. Study Identification

Unique Protocol Identification Number
NCT01925807
Brief Title
Building Resilience and Attachment in Vulnerable Adolescents
Acronym
BRAVA
Official Title
Brief Group Intervention for Adolescents With Mild to Moderate Suicidal Ideation and Their Caregivers: Preliminary Investigation for a Novel Treatment Approach
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Allison Kennedy
Collaborators
Mach Gaensslen Foundation, AFP Innovation Fund

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Suicide is the second leading cause of mortality for Canadian adolescents. Mental health complaints are one of the leading reasons for an emergency department visit at the Children's Hospital of Eastern Ontario and 60% of adolescents report suicidal ideation. The goal of the present investigation is to test the efficacy of a brief group intervention for adolescents with passive suicidal ideation and their caregivers that will focus on coping, familial support, and emotional regulation. The investigators hypothesize that a brief group intervention, delivered in the weeks following presentation for crisis services, will reduce suicidal ideation and improve coping and familial support.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicidal Ideation
Keywords
Adolescent, Suicidal Ideation, Emergency Department, Crisis, Attachment, Coping

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group Intervention
Arm Type
Experimental
Arm Description
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. For adolescents, the group sessions will focus on coping strategies and emotional regulation. For caregivers, the group sessions will be focused on attachment, family environment, and validation.
Intervention Type
Behavioral
Intervention Name(s)
Group Intervention
Intervention Description
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. For adolescents, the group sessions will focus on coping strategies and emotional regulation. For caregivers, the group sessions will be focused on attachment, family environment, and validation.
Primary Outcome Measure Information:
Title
Suicidal Ideation
Description
Suicidal ideation will be measured using the Suicidal Ideation Questionnaire Junior (SIQ-JR; Reynolds, 1988). Repeated Measures ANOVA or ANCOVA will be used to compare differences in suicidal ideation within groups (pre-post changes). Further comparisons using clinical cut-off will be conducted via McNemar test for matched pairs.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Familial Support
Description
Familial support will be measured using questionnaires for both caregivers and youth. Youth will respond to the Family Environment Scale (Koren, DeChillo, & Friesen, 1992) and the Inventory of Parent and Peer Attachment (Armsden & Greenberg, 1987). Caregivers will respond to the Family Environment Scale and and Relationship Scale Questionnaire (Griffine & Gartholomew, 1994). Repeated Measures ANOVA or ANCOVA will be used to compare differences within groups (pre-post changes).
Time Frame
6 weeks
Other Pre-specified Outcome Measures:
Title
Coping Strategies
Description
Youth coping strategies will be measured using the Youth Stress and Coping Questionnaire (Cloutier et al., 2008). Repeated Measures ANOVA or ANCOVA will be used to compare differences within groups (pre-post changes).
Time Frame
6 weeks
Title
Depression
Description
Youth depression will be measured using the Children's Depression Inventory-2 Self report (CDI-2; Kovaks, 2010). Repeated Measures ANOVA or ANCOVA will be used to compare differences within groups (pre-post changes).
Time Frame
6 weeks
Title
Anxiety
Description
Youth anxiety symptoms will be measured using the Multidimensional Anxiety Scale for Children (MASC-2; March, 1997). Repeated Measures ANOVA or ANCOVA will be used to compare differences within groups (pre-post changes).
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Mild to moderate suicidal ideation Recently presented for services in response to a psycho-social crisis (Emergency Department, MH Urgent Care) One or two caregiver(s) committed to attending the majority of sessions Exclusion Criteria: Presence of a suicidal plan and/or recent gesture/attempt Psychosis Schizophrenia Dual diagnosis Developmental disability or delay "Behavioural problem" as primary concern Major substance abuse Currently receiving mental health services (once every two weeks or more frequently) Inability to commit to majority of sessions (minimum 4 of 6 sessions) Children's aid society involvement Inability of at least one caregiver to commit to attending the majority of sessions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allison Kennedy, Ph.D.
Organizational Affiliation
Children's Hospital of Eastern Ontario
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Eastern Ontario
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H8L1
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
20215934
Citation
Diamond GS, Wintersteen MB, Brown GK, Diamond GM, Gallop R, Shelef K, Levy S. Attachment-based family therapy for adolescents with suicidal ideation: a randomized controlled trial. J Am Acad Child Adolesc Psychiatry. 2010 Feb;49(2):122-31. doi: 10.1097/00004583-201002000-00006.
Results Reference
background
PubMed Identifier
12079031
Citation
Rathus JH, Miller AL. Dialectical behavior therapy adapted for suicidal adolescents. Suicide Life Threat Behav. 2002 Summer;32(2):146-57. doi: 10.1521/suli.32.2.146.24399.
Results Reference
background
PubMed Identifier
24277469
Citation
Armsden GC, Greenberg MT. The inventory of parent and peer attachment: Individual differences and their relationship to psychological well-being in adolescence. J Youth Adolesc. 1987 Oct;16(5):427-54. doi: 10.1007/BF02202939.
Results Reference
background
Citation
Cloutier, P. F., Kennedy, A., & Glennie, E. (2008, June). Coping behaviors and intensity of non-suicidal self-harm in Canadian adolescents presenting to emergency mental health services. Poster presented at the third annual meeting of the International Society for the Study of Self-Injury (ISSS), Harvard University, Cambridge, MA.
Results Reference
background
Citation
Kovacs, M. (2010). Children's Depression Inventory Manual. Toronto, ON: Multi-Health Systems Inc.
Results Reference
background
Citation
March, J.S. (2013). Manual for the Multidimensional Anxiety Scale for Children - 2nd Edition (MASC-2). Toronto, ON: MHS Inc.
Results Reference
background
Citation
Moos, R. H., & Moos, B. S. (1981). Family environment scale manual
Results Reference
background
Citation
Reynolds, W. M. (1988). Suicidal Ideation Questionnaire Professional Manual (p. 47).
Results Reference
background
Citation
Griffine, D. W., & Garthholomew, K. (1994). The metaphysics of measurement: The case of adult attachment. (pp. 17-52).
Results Reference
background

Learn more about this trial

Building Resilience and Attachment in Vulnerable Adolescents

We'll reach out to this number within 24 hrs