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Mindfulness for Parents of Children With Autism Spectrum Disorder Autism Spectrum Disorder (ASD)

Primary Purpose

Autism Spectrum Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness-Based Stress Reduction (MSBR)
Psychoeducational Support Group (PE)
Sponsored by
Loma Linda University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder

Eligibility Criteria

3 Years - 5 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Loma Linda University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mindfulness-Based Stress Reduction (MSBR)

Psychoeducational Support Group (PE)

Arm Description

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.

PE is a 8-week group-based intervention to provide psychosocial support and resources for parents of young children with Autism Spectrum Disorder.

Outcomes

Primary Outcome Measures

Child externalizing behavior problems as evidenced by reductions in the Externalizing scores on a standardized parent-report questionnaire.
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).
Child externalizing behavior problems as evidenced by reductions in the Externalizing score on a standardized parent-report questionnaire.
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).
Child externalizing behavior problems as evidenced by reductions in the Externalizing score on a standardized parent-report questionnaire.
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).
Child externalizing behavior problems as evidenced by reductions in the Externalizing score on a standardized parent-report questionnaire.
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).

Secondary Outcome Measures

Parenting Stress
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).
Parenting Stress
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).
Parenting Stress
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).
Parenting Stress
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).

Full Information

First Posted
February 28, 2018
Last Updated
May 18, 2023
Sponsor
Loma Linda University
Collaborators
California State University, Fullerton
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1. Study Identification

Unique Protocol Identification Number
NCT03459625
Brief Title
Mindfulness for Parents of Children With Autism Spectrum Disorder Autism Spectrum Disorder
Acronym
ASD
Official Title
Mindfulness and Parent Stress Reduction: Improving Outcomes for Children With Autism Spectrum Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
July 21, 2018 (Actual)
Primary Completion Date
June 28, 2022 (Actual)
Study Completion Date
June 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Loma Linda University
Collaborators
California State University, Fullerton

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The current study examines the efficacy of Mindfulness-Based Stress Reduction (MBSR) to reduce parenting stress, lessen parental reactivity and negativity, and decrease child externalizing behaviors among families of children with Autism Spectrum Disorder (ASD). The design is a randomized controlled trial of 138 families of preschool-aged children with ASD. Parents of children with ASD will be randomized to MBSR or to a Psychoeducational (PE) support control group matched for clinical contact and dosage (see details on interventions below). 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The proposed study is a randomized controlled trial of 138 families that will be conducted in three cohorts. Each cohort will involve a recruitment phase of 46 participants. Within each cohort parents will be randomly assigned to the MBSR (N=23) or PE group (N=23), and the groups will run concurrently.
Masking
Outcomes Assessor
Masking Description
Participants 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. All assessors for laboratory assessments will remain blind to treatment group assignment for the duration of the project. Teachers will also be blind to treatment group assignment. Research assistants involved in observational coding will be blind to both treatment condition and visit time point.
Allocation
Randomized
Enrollment
117 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness-Based Stress Reduction (MSBR)
Arm Type
Experimental
Arm Description
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.
Arm Title
Psychoeducational Support Group (PE)
Arm Type
Active Comparator
Arm Description
PE is a 8-week group-based intervention to provide psychosocial support and resources for parents of young children with Autism Spectrum Disorder.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-Based Stress Reduction (MSBR)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducational Support Group (PE)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Child externalizing behavior problems as evidenced by reductions in the Externalizing scores on a standardized parent-report questionnaire.
Description
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).
Time Frame
At baseline
Title
Child externalizing behavior problems as evidenced by reductions in the Externalizing score on a standardized parent-report questionnaire.
Description
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).
Time Frame
Within 4 weeks of completing last intervention session (session 8)
Title
Child externalizing behavior problems as evidenced by reductions in the Externalizing score on a standardized parent-report questionnaire.
Description
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).
Time Frame
6-month follow-up visit
Title
Child externalizing behavior problems as evidenced by reductions in the Externalizing score on a standardized parent-report questionnaire.
Description
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).
Time Frame
12-month follow-up visit
Secondary Outcome Measure Information:
Title
Parenting Stress
Description
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).
Time Frame
Baseline
Title
Parenting Stress
Description
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).
Time Frame
Within 4 weeks of completing last intervention session (session 8)
Title
Parenting Stress
Description
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).
Time Frame
6-month follow-up visit
Title
Parenting Stress
Description
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).
Time Frame
12-month follow-up visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cameron L Neece, Ph.D.
Organizational Affiliation
Loma Linda University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loma Linda University
City
Loma Linda
State/Province
California
ZIP/Postal Code
92350
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Mindfulness for Parents of Children With Autism Spectrum Disorder Autism Spectrum Disorder

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