search
Back to results

Mindfulness for Parents of OCD-affected Children (MBST)

Primary Purpose

Obsessive-Compulsive Disorder

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Mindfulness-Based Skills Training (MBST)
Waitlist control (WLC)
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obsessive-Compulsive Disorder focused on measuring Mindfulness training, Parents and families, Pediatric OCD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • BC Children's Hospital Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Waitlist control (WLC)

Mindfulness-Based Skills Training (MBST)

Arm Description

Observation surveys over an 8-week period.

Attendance at weekly 1.5-hour group sessions and surveys over an 8-week period.

Outcomes

Primary Outcome Measures

Change in parental stress levels compared to waiting list control (WLC).
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.
Change in ability to tolerate OCD-related distress compared to waiting list control (WLC).
The ability to tolerate OCD-related distress is measured using the Parental Tolerance of Child Distress (PT-OCD) scale.

Secondary Outcome Measures

Change in ability to resist family accommodation of the child's OCD symptoms compared to waiting list control (WLC).
Family accommodation is measured by the Family Accommodation Scale (FAS)
Change in family functioning compared to the waiting list control (WLC).
Family functioning in relation to the impact of OCD on the family is measured by the OCD Family Functioning Scale (OFF).
Change in OCD severity compared to waiting list control (WLC).
OCD symptom severity is measured with the Children's Yale Brown Obsessive-Compulsive Scale (CY-BOCS), rated by the parent.
Change in OCD-associated coercive and disruptive symptoms compared to waiting list control (WLC).
Coercive and disruptive behaviours is measured using the Coercive and Disruptive behaviours in Pediatric OCD (CD-POC) scale.

Full Information

First Posted
July 4, 2017
Last Updated
January 15, 2021
Sponsor
University of British Columbia
Collaborators
Michael Smith Foundation for Health Research
search

1. Study Identification

Unique Protocol Identification Number
NCT03212703
Brief Title
Mindfulness for Parents of OCD-affected Children
Acronym
MBST
Official Title
A Trial of Mindfulness-Based Skills Training Groups Versus a Waiting List Control Period for Parents of Obsessive-Compulsive Disorder (OCD)-Affected Youth
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
July 2015 (Actual)
Primary Completion Date
September 2020 (Actual)
Study Completion Date
September 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
Collaborators
Michael Smith Foundation for Health Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-Compulsive Disorder
Keywords
Mindfulness training, Parents and families, Pediatric OCD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Waitlist control (WLC)
Arm Type
Active Comparator
Arm Description
Observation surveys over an 8-week period.
Arm Title
Mindfulness-Based Skills Training (MBST)
Arm Type
Active Comparator
Arm Description
Attendance at weekly 1.5-hour group sessions and surveys over an 8-week period.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-Based Skills Training (MBST)
Intervention Description
8-week mindfulness skills training sessions based on Mindfulness-Based Cognitive Therapy (MBCT) program by Zindel Segal, Mark Williams and John Teasdale
Intervention Type
Other
Intervention Name(s)
Waitlist control (WLC)
Intervention Description
Observation surveys at baseline, mid-point and end-point of an 8-week period
Primary Outcome Measure Information:
Title
Change in parental stress levels compared to waiting list control (WLC).
Description
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.
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)
Title
Change in ability to tolerate OCD-related distress compared to waiting list control (WLC).
Description
The ability to tolerate OCD-related distress is measured using the Parental Tolerance of Child Distress (PT-OCD) scale.
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)
Secondary Outcome Measure Information:
Title
Change in ability to resist family accommodation of the child's OCD symptoms compared to waiting list control (WLC).
Description
Family accommodation is measured by the Family Accommodation Scale (FAS)
Time Frame
Baseline (first week of P-MBST), and Post-treatment (within one week of completing 8-week P-MBST sessions).
Title
Change in family functioning compared to the waiting list control (WLC).
Description
Family functioning in relation to the impact of OCD on the family is measured by the OCD Family Functioning Scale (OFF).
Time Frame
Baseline (first week of P-MBST), and Post-treatment (within one week of completing 8-week P-MBST sessions).
Title
Change in OCD severity compared to waiting list control (WLC).
Description
OCD symptom severity is measured with the Children's Yale Brown Obsessive-Compulsive Scale (CY-BOCS), rated by the parent.
Time Frame
Baseline (first week of P-MBST), and Post-treatment (within one week of completing 8-week P-MBST sessions).
Title
Change in OCD-associated coercive and disruptive symptoms compared to waiting list control (WLC).
Description
Coercive and disruptive behaviours is measured using the Coercive and Disruptive behaviours in Pediatric OCD (CD-POC) scale.
Time Frame
Baseline (first week of P-MBST), and Post-treatment (within one week of completing 8-week P-MBST sessions).
Other Pre-specified Outcome Measures:
Title
Change in mindfulness compared to waiting list control (WLC).
Description
The Mindfulness Personality Profile (MPP) will be used to assess Mindfulness over the following four domains: Self-description - adapted from the Self-Description Questionnaire (Marsh, 1994) Awareness and attention - adapted from Mindfulness Attention Awareness Scale (Brown and Ryan, 2003) 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) Self reflection and insight scale (SRIS) ((Grant, Fraknlin and Langford, 2002)
Time Frame
Baseline (first week of P-MBST), and Post-treatment (within one week of completing 8-week P-MBST sessions).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
S. Evelyn Stewart, MD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
BC Children's Hospital Research Institute
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z4H4
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
32379640
Citation
Belschner L, Lin SY, Yamin DF, Best JR, Edalati K, McDermid J, Stewart SE. Mindfulness-based skills training group for parents of obsessive-compulsive disorder-affected children: A caregiver-focused intervention. Complement Ther Clin Pract. 2020 May;39:101098. doi: 10.1016/j.ctcp.2020.101098. Epub 2020 Jan 17.
Results Reference
derived

Learn more about this trial

Mindfulness for Parents of OCD-affected Children

We'll reach out to this number within 24 hrs