Clinical trial NCT03212703: Mindfulness for Parents of OCD-affected Children
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
Overall status: COMPLETED
Phase: NA
Conditions: Obsessive-Compulsive Disorder
Keywords: Mindfulness training
Parents and families
Pediatric OCD
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Michael Smith Foundation for Health Research
First posted: 2017-07-11
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in parental stress levels compared to waiting list control (WLC).
timeFrame: 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)
measure: Change in ability to tolerate OCD-related distress compared to waiting list control (WLC).
timeFrame: 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:
measure: Change in ability to resist family accommodation of the child's OCD symptoms compared to waiting list control (WLC).
timeFrame: Baseline (first week of P-MBST), and Post-treatment (within one week of completing 8-week P-MBST sessions).
measure: Change in family functioning compared to the waiting list control (WLC).
timeFrame: Baseline (first week of P-MBST), and Post-treatment (within one week of completing 8-week P-MBST sessions).
measure: Change in OCD severity compared to waiting list control (WLC).
timeFrame: Baseline (first week of P-MBST), and Post-treatment (within one week of completing 8-week P-MBST sessions).
measure: Change in OCD-associated coercive and disruptive symptoms compared to waiting list control (WLC).
timeFrame: Baseline (first week of P-MBST), and Post-treatment (within one week of completing 8-week P-MBST sessions).
Other outcomes:
measure: Change in mindfulness compared to waiting list control (WLC).
timeFrame: Baseline (first week of P-MBST), and Post-treatment (within one week of completing 8-week P-MBST sessions).
Locations:
city: Vancouver
country: Canada
facility: BC Children's Hospital Research Institute
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: S. Evelyn Stewart, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.