Obsessive-Compulsive DisorderMBSTNCT03212703
Mindfulness for Parents of OCD-affected Children
A study testing Mindfulness-Based Skills Training (MBST) in people with Obsessive-Compulsive Disorder, run by University of British Columbia at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- Mindfulness-Based Skills Training (MBST)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2015to Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
BC Children's Hospital Research Institute
Vancouver, British Columbia, V5Z4H4
About this study
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
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.
Read the 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.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- Mindfulness-Based Skills Training (MBST), Waitlist control (WLC)
- Keywords
- Mindfulness training, Parents and families, Pediatric OCD
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Skills Training (MBST)Behavioural
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)Other
Observation surveys at baseline, mid-point and end-point of an 8-week period
| Study group | Role | What they receive |
|---|---|---|
| Waitlist control (WLC) | Active comparator | Observation surveys over an 8-week period. Receives: 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. Receives: Other: Waitlist control (WLC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Family accommodation is measured by the Family Accommodation Scale (FAS)
Measured: 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).
Family functioning in relation to the impact of OCD on the family is measured by the OCD Family Functioning Scale (OFF).
Measured: 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).
OCD symptom severity is measured with the Children's Yale Brown Obsessive-Compulsive Scale (CY-BOCS), rated by the parent.
Measured: 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).
Coercive and disruptive behaviours is measured using the Coercive and Disruptive behaviours in Pediatric OCD (CD-POC) scale.
Measured: Baseline (first week of P-MBST), and Post-treatment (within one week of completing 8-week P-MBST sessions).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study startJul 2015
- Primary completionSep 2020
- Study completionSep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Michael Smith Foundation for Health Research
- Responsible party
- Principal investigator, Evelyn Stewart, MD, University of British Columbia
- Investigators
- S. Evelyn Stewart, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03212703
- Sponsor's protocol ID
- H14-02099
- Acronym
- MBST
- Status last verified
- Jan 2021
- First submitted
- 4 Jul 2017
- Last updated
- 19 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32379640
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03212703
- Acronym / sponsor ID
- MBST / H14-02099
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- Mindfulness training, Parents and families, Pediatric OCD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Michael Smith Foundation for Health Research
- Study start
- Jul 2015 (actual)
- Primary completion
- Sep 2020 (actual)
- Study completion
- Sep 2020 (actual)
- First posted
- 11 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Waitlist control (WLC) | Active comparator | Behavioral: Mindfulness-Based Skills Training (MBST)Observation surveys over an 8-week period. |
| Mindfulness-Based Skills Training (MBST) | Active comparator | Other: Waitlist control (WLC)Attendance at weekly 1.5-hour group sessions and surveys over an 8-week period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Behavioural | Waitlist control (WLC) |
| Waitlist control (WLC)Observation surveys at baseline, mid-point and end-point of an 8-week period | Other | Mindfulness-Based Skills Training (MBST) |
Primary outcome
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.
4 secondary outcomes
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).
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).
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).
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2021.
- Derived from this study: PubMed 32379640Belschner 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
S. Evelyn Stewart, MD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Skills Training (MBST) in people with Obsessive-Compulsive Disorder, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03212703, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2021.