- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03459625
Mindfulness for Parents of Children With Autism Spectrum Disorder Autism Spectrum Disorder (ASD)
Mindfulness and Parent Stress Reduction: Improving Outcomes for Children With Autism Spectrum Disorder
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Families of children with Autism Spectrum Disorder (ASD) experience heightened risk due to elevated rates of clinically-significant parenting stress and child externalizing behavior problems. Parenting stress is a robust predictor of subsequent externalizing challenges in children with ASD. Nonetheless, few evidenced-based treatments exist for reducing parenting stress in these families. The mechanisms through which parenting stress influence child externalizing problems are also unclear, although preliminary evidence suggests the potential role of negative parenting behaviors. This study comprehensively addresses these considerations by testing the efficacy of Mindfulness-Based Stress Reduction (MBSR) as an intervention to reduce parenting stress, lessen parental reactivity and negativity, and decrease child externalizing behaviors.
MBSR is particularly well-suited for parents of children with ASD given the intervention emphasis on teaching participants to manage reactivity in the context of persistent stress. However, the efficacy of MBSR has yet to be established for this population. The present investigation extends preliminary investigations of mindfulness approaches by: 1) conducting a stringent test of MSBR using an active psychoeducational (PE) control, 2) developing population-specific content and testing the efficacy of MSBR for parents of children with ASD, 3) utilizing a highly diverse, underserved community-based sample, 4) examining the mechanisms underlying observed treatment effects, and 5) employing multi-method longitudinal measurement from multiple sources in order to examine immediate and long-term treatment effects.
The current study is a randomized controlled trial of 138 families of preschool-aged children with ASD. Parents will be randomized to MBSR or to a PE support group matched for clinical contact and dosage. Families will participate in laboratory assessments at baseline and immediately post-treatment, as well as at 6 months and 12 months post-treatment. Measures include standardized and validated parent and teacher questionnaires, gold-standard psychological assessments, and observational and interview ratings.
The MBSR intervention includes eight weekly 2.5-hour group sessions, a day-long (6hr) meditation retreat on the weekend during week six, 45 minutes of daily home practice guided by instructional audio CDs (portable CD players will be provided when necessary), and an MBSR parent workbook. Formal mindfulness exercises aim to increase the capacity for mindfulness (present-moment awareness with a compassionate, non-judgmental stance) and include a body scan, mindful yoga, and sitting meditation. Participants are also taught to practice mindfulness informally in everyday activities. In session, didactic instruction on stress physiology and using mindfulness for coping with stress in daily life is provided. Participants practice formal mindfulness exercises, break into dyads to discuss their daily homework practice, and meet as a larger group to ask questions related to the practice of mindfulness in everyday life.
In order to provide a rigorous test of the contributions of mindfulness techniques, the current investigation will control for therapeutic effects associated with clinician contact and group support by comparing MBSR to a PE support condition matched for dosage. The PE condition also consists of 8-weekly 2.5-hour sessions, a day-long (6hr) Family Resource Fair during week six (wherein families will attend talks by professionals, explore available local resources, and meet with service providers), daily homework that includes monitoring progress on goals identified at the end of each session, and a workbook for parents of children with special needs that provides parents with information regarding their child's development, disability, and associated considerations.
Establishing an efficacious stress reduction intervention to target mechanisms linking parenting stress, negative parenting behaviors, and child externalizing problems will advance clinical science and optimize outcomes for children with ASD and their families.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Loma Linda, California, United States, 92350
- Loma Linda University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Child community diagnosis of ASD confirmed by study administered assessments
- Age 3 to 5 years
- Elevated parenting stress as indexed by a total score above the recommended cutoff at the 85th percentile on the Parenting Stress Index-4 (Abidin, 1995)
- Abbreviated Battery IQ (ABIQ) score above 35 on the Stanford-Binet Intelligence Scales 5th Edition ABIQ to ensure task validity (SB5 ABIQ; Roid, 2003)
Exclusion Criteria:
- Positive screen for active parental psychosis, substance abuse, or suicidality according to the associated modules of the Structured Clinical Interview for DSM Disorders, SCID, Research Version Non-Patient Edition (First, Spitzer, Gibbon, & Williams, 2002)
- Parent participation in an auxiliary mental health treatment or support group
- < 3 years or > 5 years of age
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Mindfulness-Based Stress Reduction (MSBR)
MSBR (Kabat-Zinn, 1990), 8-week group-based intervention where participants learn mindfulness skills to help alleviate parenting stress among parents of young children with Autism Spectrum Disorder.
|
MBSR includes eight weekly 2.5-hour group sessions, a day-long (6hr) meditation retreat on the weekend during week six, 45 minutes of daily home practice guided by instructional audio CDs, and an MBSR parent workbook.
Formal mindfulness exercises aim to increase the capacity for mindfulness and include a body scan, mindful yoga, and sitting meditation.
Participants are also taught to practice mindfulness informally in everyday activities.
In session, didactic instruction on stress physiology and using mindfulness for coping with stress in daily life is provided.
Participants practice formal mindfulness exercises, break into dyads to discuss their daily homework practice, and meet as a larger group to ask questions related to the practice of mindfulness in everyday life.
|
Active Comparator: Psychoeducational Support Group (PE)
PE is a 8-week group-based intervention to provide psychosocial support and resources for parents of young children with Autism Spectrum Disorder.
|
The PE consists of 8-weekly 2.5-hour sessions, a day-long (6hr) Family Resource Fair during week six, daily homework that includes monitoring progress on goals identified at the end of each session, and a workbook for parents of children with special needs that provides parents with information regarding their child's development, disability, and associated considerations.
Weekly topics for discussion include Preparing for Individualized Education Plan (IEP) meetings, Communicating with Teachers, Advocacy, Sibling Issues, and Community Resources.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Child externalizing behavior problems as evidenced by reductions in the Externalizing scores on a standardized parent-report questionnaire.
Time Frame: At baseline
|
Assessment will be based on reductions parent ratings on the Externalizing Problems t-score of the Child Behavior Checklist (CBCL)-Ages 1.5-5.
The CBCL has 99 items that assess the degree or frequency of child behavior problems.
Each item is rated on a scale of 0 (not true), 1 (somewhat or sometimes true), or 2 (very true or often true).
|
At baseline
|
Child externalizing behavior problems as evidenced by reductions in the Externalizing score on a standardized parent-report questionnaire.
Time Frame: Within 4 weeks of completing last intervention session (session 8)
|
Assessment will be based on reductions parent ratings on the Externalizing Problems t-score of the Child Behavior Checklist (CBCL)-Ages 1.5-5.
The CBCL has 99 items that assess the degree or frequency of child behavior problems.
Each item is rated on a scale of 0 (not true), 1 (somewhat or sometimes true), or 2 (very true or often true).
|
Within 4 weeks of completing last intervention session (session 8)
|
Child externalizing behavior problems as evidenced by reductions in the Externalizing score on a standardized parent-report questionnaire.
Time Frame: 6-month follow-up visit
|
Assessment will be based on reductions parent ratings on the Externalizing Problems t-score of the Child Behavior Checklist (CBCL)-Ages 1.5-5.
The CBCL has 99 items that assess the degree or frequency of child behavior problems.
Each item is rated on a scale of 0 (not true), 1 (somewhat or sometimes true), or 2 (very true or often true).
|
6-month follow-up visit
|
Child externalizing behavior problems as evidenced by reductions in the Externalizing score on a standardized parent-report questionnaire.
Time Frame: 12-month follow-up visit
|
Assessment will be based on reductions parent ratings on the Externalizing Problems t-score of the Child Behavior Checklist (CBCL)-Ages 1.5-5.
The CBCL has 99 items that assess the degree or frequency of child behavior problems.
Each item is rated on a scale of 0 (not true), 1 (somewhat or sometimes true), or 2 (very true or often true).
|
12-month follow-up visit
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Parenting Stress
Time Frame: Baseline
|
Assessment will be based in parent participant reports on the Parental Distress subscale of the Parenting Stress Index-Fourth Edition, Short Form.
The PSI includes 36 items that are rated on a five-point scale that ranges from 1 (strongly agree) to 5 (strongly disagree).
|
Baseline
|
Parenting Stress
Time Frame: Within 4 weeks of completing last intervention session (session 8)
|
Assessment will be based in parent participant reports on the Parental Distress subscale of the Parenting Stress Index-Fourth Edition, Short Form.
The PSI includes 36 items that are rated on a five-point scale that ranges from 1 (strongly agree) to 5 (strongly disagree).
|
Within 4 weeks of completing last intervention session (session 8)
|
Parenting Stress
Time Frame: 6-month follow-up visit
|
Assessment will be based in parent participant reports on the Parental Distress subscale of the Parenting Stress Index-Fourth Edition, Short Form.
The PSI includes 36 items that are rated on a five-point scale that ranges from 1 (strongly agree) to 5 (strongly disagree).
|
6-month follow-up visit
|
Parenting Stress
Time Frame: 12-month follow-up visit
|
Assessment will be based in parent participant reports on the Parental Distress subscale of the Parenting Stress Index-Fourth Edition, Short Form.
The PSI includes 36 items that are rated on a five-point scale that ranges from 1 (strongly agree) to 5 (strongly disagree).
|
12-month follow-up visit
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Cameron L Neece, Ph.D., Loma Linda University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5110264
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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