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Mindfulness for Parents of OCD-affected Children (MBST)

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ClinicalTrials.gov Identifier: NCT03212703
Recruitment Status : Recruiting
First Posted : July 11, 2017
Last Update Posted : October 11, 2018
Sponsor:
Collaborator:
Michael Smith Foundation for Health Research
Information provided by (Responsible Party):
Evelyn Stewart, University of British Columbia

Tracking Information
First Submitted Date  ICMJE July 4, 2017
First Posted Date  ICMJE July 11, 2017
Last Update Posted Date October 11, 2018
Actual Study Start Date  ICMJE July 2015
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 6, 2017)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03212703 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 6, 2017)
  • 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)
  • 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).
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 6, 2017)
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)
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Mindfulness for Parents of OCD-affected Children
Official Title  ICMJE A Trial of Mindfulness-Based Skills Training Groups Versus a Waiting List Control Period for Parents of Obsessive-Compulsive Disorder (OCD)-Affected Youth
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Obsessive-Compulsive Disorder
Intervention  ICMJE
  • Behavioral: Mindfulness-Based Skills Training (MBST)
    8-week mindfulness skills training sessions based on Mindfulness-Based Cognitive Therapy (MBCT) program by Zindel Segal, Mark Williams and John Teasdale
  • Other: Waitlist control (WLC)
    Observation surveys at baseline, mid-point and end-point of an 8-week period
Study Arms  ICMJE
  • Active Comparator: Waitlist control (WLC)
    Observation surveys over an 8-week period.
    Intervention: Behavioral: Mindfulness-Based Skills Training (MBST)
  • Active Comparator: Mindfulness-Based Skills Training (MBST)
    Attendance at weekly 1.5-hour group sessions and surveys over an 8-week period.
    Intervention: Other: Waitlist control (WLC)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 6, 2017)
45
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2019
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Diana Franco Yamin, MA dfrancoy@bcchr.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03212703
Other Study ID Numbers  ICMJE H14-02099
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Evelyn Stewart, University of British Columbia
Study Sponsor  ICMJE University of British Columbia
Collaborators  ICMJE Michael Smith Foundation for Health Research
Investigators  ICMJE
Principal Investigator: S. Evelyn Stewart, MD University of British Columbia
PRS Account University of British Columbia
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP