NCT03212703

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

July 4, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 11, 2017

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

January 19, 2021

Status Verified

January 1, 2021

Enrollment Period

5.2 years

First QC Date

July 4, 2017

Last Update Submit

January 15, 2021

Conditions

Keywords

Mindfulness trainingParents and familiesPediatric OCD

Outcome Measures

Primary Outcomes (2)

  • 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.

    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).

    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 Outcomes (4)

  • Change in ability to resist family accommodation of the child's OCD symptoms compared to waiting list control (WLC).

    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).

    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).

    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).

    Baseline (first week of P-MBST), and Post-treatment (within one week of completing 8-week P-MBST sessions).

Other Outcomes (1)

  • Change in mindfulness compared to waiting list control (WLC).

    Baseline (first week of P-MBST), and Post-treatment (within one week of completing 8-week P-MBST sessions).

Study Arms (2)

Waitlist control (WLC)

ACTIVE COMPARATOR

Observation surveys over an 8-week period.

Behavioral: Mindfulness-Based Skills Training (MBST)

Mindfulness-Based Skills Training (MBST)

ACTIVE COMPARATOR

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

Other: Waitlist control (WLC)

Interventions

8-week mindfulness skills training sessions based on Mindfulness-Based Cognitive Therapy (MBCT) program by Zindel Segal, Mark Williams and John Teasdale

Waitlist control (WLC)

Observation surveys at baseline, mid-point and end-point of an 8-week period

Mindfulness-Based Skills Training (MBST)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BC Children's Hospital Research Institute

Vancouver, British Columbia, V5Z4H4, Canada

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Study Officials

  • S. Evelyn Stewart, MD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 4, 2017

First Posted

July 11, 2017

Study Start

July 1, 2015

Primary Completion

September 1, 2020

Study Completion

September 1, 2020

Last Updated

January 19, 2021

Record last verified: 2021-01

Locations