Evaluating a Peer-Facilitated Skills-Based Intervention for Caregivers of Concurrent Disordered Youth
Primary Purpose
Caregiver Burden
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
DBT Based Skills Groups for Families
Sponsored by
About this trial
This is an interventional treatment trial for Caregiver Burden focused on measuring Concurrent Disorders, Mental Health, Addictions, Caregiver Burden
Eligibility Criteria
Inclusion Criteria:
- 18 years of age or older,
- literacy in English,
- are family members of an adolescent scoring in the clinical range on at least one subscale of the Child Behavior Checklist (CBCL)
Exclusion Criteria:
- has adolescent children participating in the sister youth intervention protocol #069-2011.
Sites / Locations
- Centre for Addiction and Mental Health
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
DBT Based Skills Groups for Families
Arm Description
Family members of youth with concurrent disorder participate in a 12-week DBT based skills group led by therapists and/or peer facilitators.
Outcomes
Primary Outcome Measures
Family member burden & psychological stress as measured by the Burden Assessment Scale
The primary outcome measure will examine change in family member burden and stress from baseline on standardized assessment instruments
Secondary Outcome Measures
Full Information
NCT ID
NCT02243761
First Posted
June 24, 2014
Last Updated
April 2, 2015
Sponsor
Centre for Addiction and Mental Health
Collaborators
Canadian Institutes of Health Research (CIHR), Childrens Centre Thunder Bay
1. Study Identification
Unique Protocol Identification Number
NCT02243761
Brief Title
Evaluating a Peer-Facilitated Skills-Based Intervention for Caregivers of Concurrent Disordered Youth
Official Title
Canadian Institutes of Health Research (CIHR) Team in Innovations in Child and Youth Concurrent Disorders: Service Delivery and Treatment Subproject
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre for Addiction and Mental Health
Collaborators
Canadian Institutes of Health Research (CIHR), Childrens Centre Thunder Bay
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Families of adolescents struggling with comorbid mental illness and addiction problems typically experience considerable emotional, financial and social burdens. Concurrent disorders (CDs) within families contribute to added stress and interpersonal conflict, as well as disrupt normal routines such as social and occupational activities. Despite the difficulties associated with being a family member of youth with CD, current mental health and addictions practices neglect to address this population. The overall purpose of this project is to assess the feasibility and clinical effectiveness of a Dialectical Behaviour Therapy skills (DBT) based training group for families of youth with CDs. The following main hypothesis will be examined: Family members of youth with concurrent disorders who participate in a 12-week skills group led by therapists and/or peer facilitators will show reduced caregiver burden and parenting stress from pre to post treatment.
Detailed Description
This study is designed to assess whether a 12-week skills based intervention is feasible and effective in addressing issues experienced by families of youth with concurrent mental health and addiction problems. Eligible subjects will be invited to participate in the following intervention:
The intervention is based on a DBT skills training model for families, the Family Connections© model. This model was originally developed for families of individuals with Borderline Personality Disorder (BPD) and later adapted for this study for CD.The Family Connections model is a 12-week (90-minute once-weekly sessions) skills training group designed to be led by therapists and/or peer support facilitators. The family groups in this study will be facilitated by two family members with experience being part of a family group and training and they will work with or without a professional therapist. Groups will consist of a maximum of 16 family members. Family members will receive a manual which describes the skills to be covered.
The skills-training will be delivered in two cities in collaboration with two organizations: CAMH, Toronto and the Children's Centre Thunder Bay. Participants will be recruited through advertisements posted on flyers and relevant websites.
The family intervention will evaluate change over time and use a mixed between/within subject, pre/post and follow-up design. Assessments will occur at baseline, mid-skills training (4 weeks), after 12-week skills training (post intervention), and at 12-week post intervention follow-up.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caregiver Burden
Keywords
Concurrent Disorders, Mental Health, Addictions, Caregiver Burden
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DBT Based Skills Groups for Families
Arm Type
Experimental
Arm Description
Family members of youth with concurrent disorder participate in a 12-week DBT based skills group led by therapists and/or peer facilitators.
Intervention Type
Other
Intervention Name(s)
DBT Based Skills Groups for Families
Intervention Description
12 weeks of Dialectical Behaviour Therapy skills training group for families (90-minute once-weekly sessions)
Primary Outcome Measure Information:
Title
Family member burden & psychological stress as measured by the Burden Assessment Scale
Description
The primary outcome measure will examine change in family member burden and stress from baseline on standardized assessment instruments
Time Frame
Baseline, Mid-intervention (4 weeks post-baseline), Post-intervention (12 weeks post baseline), and at 12 weeks follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
18 years of age or older,
literacy in English,
are family members of an adolescent scoring in the clinical range on at least one subscale of the Child Behavior Checklist (CBCL)
Exclusion Criteria:
has adolescent children participating in the sister youth intervention protocol #069-2011.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shelley McMain, PhD
Organizational Affiliation
Centre for Addiction and Mental Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Addiction and Mental Health
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5S 2S1
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Evaluating a Peer-Facilitated Skills-Based Intervention for Caregivers of Concurrent Disordered Youth
We'll reach out to this number within 24 hrs