Caregiver BurdenNCT02243761
Evaluating a Peer-Facilitated Skills-Based Intervention for Caregivers of Concurrent Disordered Youth
A study testing DBT Based Skills Groups for Families in people with Caregiver Burden, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Caregiver Burden
- What is being tested?
- DBT Based Skills Groups for Families
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2012to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- has adolescent children participating in the sister youth intervention protocol #069-2011.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Canadian Institutes of Health Research (CIHR) Team in Innovations in Child and Youth Concurrent Disorders: Service Delivery and Treatment Subproject
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.
Read the 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.
- Conditions
- Caregiver Burden
- Being tested
- DBT Based Skills Groups for Families
- Keywords
- Concurrent Disorders, Mental Health, Addictions, Caregiver Burden
- Medical subject headings
- Caregiver Burden, Psychological Well-Being, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DBT Based Skills Groups for FamiliesOther
12 weeks of Dialectical Behaviour Therapy skills training group for families (90-minute once-weekly sessions)
| Study group | Role | What they receive |
|---|---|---|
| DBT Based Skills Groups for Families | Experimental | Family members of youth with concurrent disorder participate in a 12-week DBT based skills group led by therapists and/or peer facilitators. Receives: Other: DBT Based Skills Groups for Families |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, Mid-intervention (4 weeks post-baseline), Post-intervention (12 weeks post baseline), and at 12 weeks follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2014 (estimated)
- Study startAug 2012
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caregiver BurdenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Childrens Centre Thunder Bay
- Responsible party
- Principal investigator, Shelley McMain, Centre for Addiction and Mental Health
- Investigators
- Shelley McMain, PhD, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02243761
- Sponsor's protocol ID
- 129/2012
- Status last verified
- Apr 2015
- First submitted
- 24 Jun 2014
- Last updated
- 6 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Canadian Institutes of Health Research (CIHR) Team in Innovations in Child and Youth Concurrent Disorders: Service Delivery and Treatment Subproject
- ClinicalTrials.gov ID
- NCT02243761
- Acronym / sponsor ID
- 129/2012
- Conditions
- Caregiver Burden
- Keywords
- Concurrent Disorders, Mental Health, Addictions, Caregiver Burden
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Childrens Centre Thunder Bay
- Study start
- Aug 2012
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 18 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DBT Based Skills Groups for Families | Experimental | Other: DBT Based Skills Groups for FamiliesFamily members of youth with concurrent disorder participate in a 12-week DBT based skills group led by therapists and/or peer facilitators. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (1 listed)
- has adolescent children participating in the sister youth intervention protocol #069-2011.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DBT Based Skills Groups for Families12 weeks of Dialectical Behaviour Therapy skills training group for families (90-minute once-weekly sessions) | Other | DBT Based Skills Groups for Families |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2015.
Related trials for Caregiver Burden
Recruiting
Anticipated Patient and Caregiver Burden
Amyotrophic Lateral Sclerosis
Recruiting
The Coma Family Program (COMA-F): A Resilience Program for Caregivers of Patients With Severe Acute Brain Injury
Caregiver Distress, Emotional Distress
Not yet recruiting
Negotiation Training for Family Caregivers of People With Alzheimer's Disease
Alzheimer's Disease (AD), Dementia
RecruitingObservational study
Friends/Family of Individuals at Risk of Suicide Training Program
Caregiver, Caregiver Mental Health
Not yet recruiting
VICA: A Virtual Care Assistant for Dementia Caregivers
Alzheimer Dementia (AD), Caregiver Burden of People With Dementia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shelley McMain, PhD principal investigator
Centre for Addiction and Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DBT Based Skills Groups for Families in people with Caregiver Burden, run by Centre for Addiction and Mental Health at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2015.