Mindfulness for Parents of OCD-affected Children

Obsessive-Compulsive Disorder Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03212703
• Other study ID #: H14-02099
• Status: Completed
• Phase: N/A
• Start date: July 2015
• Est. completion date: September 2020

Study information

• Verified date: January 2021
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: September 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Obsessive-Compulsive Disorder

Intervention

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

Locations

Country	Name	City	State
Canada	BC Children's Hospital Research Institute	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	Michael Smith Foundation for Health Research

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in mindfulness compared to waiting list control (WLC).	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)	Baseline (first week of P-MBST), and Post-treatment (within one week of completing 8-week P-MBST sessions).
Primary	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)
Primary	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	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)	Baseline (first week of P-MBST), and Post-treatment (within one week of completing 8-week P-MBST sessions).
Secondary	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).	Baseline (first week of P-MBST), and Post-treatment (within one week of completing 8-week P-MBST sessions).
Secondary	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.	Baseline (first week of P-MBST), and Post-treatment (within one week of completing 8-week P-MBST sessions).
Secondary	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.	Baseline (first week of P-MBST), and Post-treatment (within one week of completing 8-week P-MBST sessions).