- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03212703
Mindfulness for Parents of OCD-affected Children (MBST)
A Trial of Mindfulness-Based Skills Training Groups Versus a Waiting List Control Period for Parents of Obsessive-Compulsive Disorder (OCD)-Affected Youth
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Obsessive-compulsive disorder (OCD) is a debilitating psychiatric illness that frequently begins in childhood. It is characterized by obsessions and/or compulsions that are distressing, time consuming and significantly impairing. OCD is distinct in the extent to which it disrupts family functioning, in that there is intense parental pressure to become involved in rituals and to change home environments and schedules to avoid triggers, thus accommodating the OCD. It is also well known that OCD severity tends to worsen in the context of stressful environments and situations. While effective treatment approaches for pediatric OCD have been identified, partial response and treatment refusal are all too common, leading to chronicity of both the illness itself and of its deleterious familial effects.
The investigators plan to study a novel approach to help manage the stress of parenting a child with OCD, thus facilitating more effective resistance to OCD family accommodation and supporting the child in fighting this difficult illness. The investigators will explore the role of group-based mindfulness-based skills training (P-MBST) in supporting parents of OCD-affected youth, in particular investigating the possibility that increased distress tolerance as a result of mindfulness practice may help parents reduce OCD accommodation.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
British Columbia
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Vancouver, British Columbia, Canada, V5Z4H4
- BC Children's Hospital Research Institute
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Parents (or step-parents or legal guardians) with care-giving role for an OCD-affected youth from our clinic
- Participants must be able to converse in English
- Participants willing to attend 8 sessions of a weekly 1.5 hour group, in addition to complete questionnaires at multiple time points during the group and waiting list period.
Exclusion Criteria:
- Parents who have previously participated in mindfulness skills training.
- Parents with active psychosis, mania, mental retardation, autism or current substance misuse.
- Parents unwilling to provide consent.
- Families who are not attending our program's group-family Cognitive-Behavioral Therapy treatment concurrently.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Waitlist control (WLC)
Observation surveys over an 8-week period.
|
8-week mindfulness skills training sessions based on Mindfulness-Based Cognitive Therapy (MBCT) program by Zindel Segal, Mark Williams and John Teasdale
|
ACTIVE_COMPARATOR: Mindfulness-Based Skills Training (MBST)
Attendance at weekly 1.5-hour group sessions and surveys over an 8-week period.
|
Observation surveys at baseline, mid-point and end-point of an 8-week period
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in parental stress levels compared to waiting list control (WLC).
Time Frame: Baseline (first week of P-MBST), Mid-treatment (fifth week of P-MBST), Post-treatment (within one week of completing 8-week P-MBST sessions) and follow-up (one month following P-MBST)
|
Parental stress levels is measured using the Parenting Stress Index - Short Form (PSI-SF) for parents with children under 13 years of age and the Stress Index for Parents of Adolescents - Short Form (SIPA-SF) for parents with children who are 13 years and older.
The PSI-SF and SIPA-SF are both measures of parental stress, but with a difference in age cut-off.
|
Baseline (first week of P-MBST), Mid-treatment (fifth week of P-MBST), Post-treatment (within one week of completing 8-week P-MBST sessions) and follow-up (one month following P-MBST)
|
Change in ability to tolerate OCD-related distress compared to waiting list control (WLC).
Time Frame: Baseline (first week of P-MBST), Mid-treatment (fifth week of P-MBST), Post-treatment (within one week of completing 8-week P-MBST sessions) and follow-up (one month following P-MBST)
|
The ability to tolerate OCD-related distress is measured using the Parental Tolerance of Child Distress (PT-OCD) scale.
|
Baseline (first week of P-MBST), Mid-treatment (fifth week of P-MBST), Post-treatment (within one week of completing 8-week P-MBST sessions) and follow-up (one month following P-MBST)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in ability to resist family accommodation of the child's OCD symptoms compared to waiting list control (WLC).
Time Frame: Baseline (first week of P-MBST), and Post-treatment (within one week of completing 8-week P-MBST sessions).
|
Family accommodation is measured by the Family Accommodation Scale (FAS)
|
Baseline (first week of P-MBST), and Post-treatment (within one week of completing 8-week P-MBST sessions).
|
Change in family functioning compared to the waiting list control (WLC).
Time Frame: Baseline (first week of P-MBST), and Post-treatment (within one week of completing 8-week P-MBST sessions).
|
Family functioning in relation to the impact of OCD on the family is measured by the OCD Family Functioning Scale (OFF).
|
Baseline (first week of P-MBST), and Post-treatment (within one week of completing 8-week P-MBST sessions).
|
Change in OCD severity compared to waiting list control (WLC).
Time Frame: Baseline (first week of P-MBST), and Post-treatment (within one week of completing 8-week P-MBST sessions).
|
OCD symptom severity is measured with the Children's Yale Brown Obsessive-Compulsive Scale (CY-BOCS), rated by the parent.
|
Baseline (first week of P-MBST), and Post-treatment (within one week of completing 8-week P-MBST sessions).
|
Change in OCD-associated coercive and disruptive symptoms compared to waiting list control (WLC).
Time Frame: Baseline (first week of P-MBST), and Post-treatment (within one week of completing 8-week P-MBST sessions).
|
Coercive and disruptive behaviours is measured using the Coercive and Disruptive behaviours in Pediatric OCD (CD-POC) scale.
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Baseline (first week of P-MBST), and Post-treatment (within one week of completing 8-week P-MBST sessions).
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in mindfulness compared to waiting list control (WLC).
Time Frame: Baseline (first week of P-MBST), and Post-treatment (within one week of completing 8-week P-MBST sessions).
|
The Mindfulness Personality Profile (MPP) will be used to assess Mindfulness over the following four domains:
|
Baseline (first week of P-MBST), and Post-treatment (within one week of completing 8-week P-MBST sessions).
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H14-02099
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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