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Clinical Trials/NCT02243761
NCT02243761CompletedNot Applicable

Canadian Institutes of Health Research (CIHR) Team in Innovations in Child and Youth Concurrent Disorders: Service Delivery and Treatment Subproject

Centre for Addiction and Mental Health2 sites in 1 country100 target enrollmentStarted: August 2012Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
100
Locations
2
Primary Endpoint
Family member burden & psychological stress as measured by the Burden Assessment Scale

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Outcomes

Primary Outcomes

Family member burden & psychological stress as measured by the Burden Assessment Scale

Time Frame: Baseline, Mid-intervention (4 weeks post-baseline), Post-intervention (12 weeks post baseline), and at 12 weeks follow-up

The primary outcome measure will examine change in family member burden and stress from baseline on standardized assessment instruments

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Shelley McMain

Head, Borderline Personality Disorder Clinic

Centre for Addiction and Mental Health

Study Sites (2)

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