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

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ClinicalTrials.gov Identifier: NCT03459625
Recruitment Status : Recruiting
First Posted : March 9, 2018
Last Update Posted : August 7, 2018
Sponsor:
Collaborator:
California State University, Fullerton
Information provided by (Responsible Party):
Cameron Neece, Loma Linda University

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.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Behavioral: Mindfulness-Based Stress Reduction (MSBR) Behavioral: Psychoeducational Support Group (PE) Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 138 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Single (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.
Primary Purpose: Treatment
Official Title: Mindfulness and Parent Stress Reduction: Improving Outcomes for Children With Autism Spectrum Disorder
Actual Study Start Date : July 21, 2018
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


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.
Behavioral: Mindfulness-Based Stress Reduction (MSBR)
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.
Behavioral: Psychoeducational Support Group (PE)
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 Measures :
  1. 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).

  2. 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).

  3. 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).

  4. 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).


Secondary Outcome Measures :
  1. 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).

  2. 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).

  3. 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).

  4. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03459625


Contacts
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Contact: Cameron L Neece, Ph.D. 510-453-4274 cneece@llu.edu

Locations
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United States, California
Loma Linda University Recruiting
Loma Linda, California, United States, 92350
Contact: Cameron Neece, Ph.D.    510-453-4274    cneece@llu.edu   
Contact: David Vermeersch, Ph.D.    9093277896    dvermeersch@llu.edu   
Sponsors and Collaborators
Loma Linda University
California State University, Fullerton
Investigators
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Principal Investigator: Cameron L Neece, Ph.D. Loma Linda University

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Responsible Party: Cameron Neece, Associate Professor, Loma Linda University
ClinicalTrials.gov Identifier: NCT03459625     History of Changes
Other Study ID Numbers: 5110264
First Posted: March 9, 2018    Key Record Dates
Last Update Posted: August 7, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Disease
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Pathologic Processes
Neurodevelopmental Disorders
Mental Disorders