Building Resilience and Attachment in Vulnerable Adolescents (BRAVA)

August 10, 2017 updated by: Allison Kennedy

Brief Group Intervention for Adolescents With Mild to Moderate Suicidal Ideation and Their Caregivers: Preliminary Investigation for a Novel Treatment Approach

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ontario
      • Ottawa, Ontario, Canada, K1H8L1
        • Children's Hospital of Eastern Ontario

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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. 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Suicidal Ideation
Time Frame: 6 weeks

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.

6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Familial Support
Time Frame: 6 weeks

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).

6 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Coping Strategies
Time Frame: 6 weeks

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).

6 weeks
Depression
Time Frame: 6 weeks

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).

6 weeks
Anxiety
Time Frame: 6 weeks

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).

6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Allison Kennedy, Ph.D., Children's Hospital of Eastern Ontario

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

August 14, 2013

First Submitted That Met QC Criteria

August 16, 2013

First Posted (Estimate)

August 20, 2013

Study Record Updates

Last Update Posted (Actual)

August 14, 2017

Last Update Submitted That Met QC Criteria

August 10, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • CHAMO_SI_Group_001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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