Mindfulness for Parents of OCD-affected Children (MBST)

January 15, 2021 updated by: Evelyn Stewart, MD, University of British Columbia

A Trial of Mindfulness-Based Skills Training Groups Versus a Waiting List Control Period for Parents of Obsessive-Compulsive Disorder (OCD)-Affected Youth

The purpose of this study is to investigate the role of a mindfulness-based skills training program for parents of children with obsessive compulsive disorder (OCD). The investigators will explore if parents involved in this group experience any change in their levels of stress, feelings of being an effective parent and family relationships compared to a waiting list control period. The investigators will look at how the family manages OCD in their lives. In particular, if mindfulness skills training will help increase the parents ability to tolerate distress in their child secondary to OCD and as such reduce the family accommodation of OCD. As family accommodation is an important negative prognostic predictor for children with OCD, changes in OCD symptom severity and functional impact in these child will also be measured.

Study Overview

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

Interventional

Enrollment (Actual)

39

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

    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z4H4
        • BC Children's Hospital Research Institute

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Parents (or step-parents or legal guardians) with care-giving role for an OCD-affected youth from our clinic
  2. Participants must be able to converse in English
  3. 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:

  1. Parents who have previously participated in mindfulness skills training.
  2. Parents with active psychosis, mania, mental retardation, autism or current substance misuse.
  3. Parents unwilling to provide consent.
  4. Families who are not attending our program's group-family Cognitive-Behavioral Therapy treatment concurrently.

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: 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.
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:

  1. Self-description - adapted from the Self-Description Questionnaire (Marsh, 1994)
  2. Awareness and attention - adapted from Mindfulness Attention Awareness Scale (Brown and Ryan, 2003)
  3. Self-compassion and time - adapted from the Self-Compassion Scale (Raes et al., 2011) and Adolescent Time Inventory (Mellow and Worrell, 2007; Mello et al., 2013)
  4. Self reflection and insight scale (SRIS) ((Grant, Fraknlin and Langford, 2002)
Baseline (first week of P-MBST), and Post-treatment (within one week of completing 8-week P-MBST sessions).

Collaborators and Investigators

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

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.

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 (ACTUAL)

July 1, 2015

Primary Completion (ACTUAL)

September 1, 2020

Study Completion (ACTUAL)

September 1, 2020

Study Registration Dates

First Submitted

July 4, 2017

First Submitted That Met QC Criteria

July 6, 2017

First Posted (ACTUAL)

July 11, 2017

Study Record Updates

Last Update Posted (ACTUAL)

January 19, 2021

Last Update Submitted That Met QC Criteria

January 15, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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