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

NCT03459625 | Completed Results DMC

• 1 other identifier: 5110264
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (4)

• 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-Ages 1.5-5. The Child Behavior Checklist 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). T-scores on the Externalizing Problems sub-scale of the Child Behavior Checklist have a theoretical population mean of 50 and a standard deviation of 10. Higher scores indicating more behavior problems. A t-score between 60 and 63 on the Externalizing Problems sub-scale is considered Borderline and a t-score above 63 is considered Clinical.

  At baseline

• 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-Ages 1.5-5. The Child Behavior Checklist 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). T-scores on the Externalizing Problems sub-scale of the Child Behavior Checklist have a theoretical population mean of 50 and a standard deviation of 10. Higher scores indicating more behavior problems. A t-score between 60 and 63 on the Externalizing Problems sub-scale is considered Borderline and a t-score above 63 is considered Clinical.

  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.

  Assessment will be based on reductions parent ratings on the Externalizing Problems t-score of the Child Behavior Checklist-Ages 1.5-5. The Child Behavior Checklist 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). T-scores on the Externalizing Problems sub-scale of the Child Behavior Checklist have a theoretical population mean of 50 and a standard deviation of 10. Higher scores indicating more behavior problems. A t-score between 60 and 63 on the Externalizing Problems sub-scale is considered Borderline and a t-score above 63 is considered Clinical.

  6-month follow-up visit

• 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-Ages 1.5-5. The Child Behavior Checklist 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). T-scores on the Externalizing Problems sub-scale of the Child Behavior Checklist have a theoretical population mean of 50 and a standard deviation of 10. Higher scores indicating more behavior problems. A t-score between 60 and 63 on the Externalizing Problems sub-scale is considered Borderline and a t-score above 63 is considered Clinical.

  12-month follow-up visit

Secondary Outcomes (4)

• Parenting Stress

  Baseline

• Parenting Stress

  Within 4 weeks of completing last intervention session (session 8)

• Parenting Stress

  6-month follow-up visit

• Parenting Stress

  12-month follow-up visit

Study Arms (2)

Mindfulness-Based Stress Reduction (MSBR)

EXPERIMENTAL

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)

Psychoeducational Support Group (PE)

ACTIVE COMPARATOR

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)

Interventions

Mindfulness-Based Stress Reduction (MSBR) BEHAVIORAL

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.

Mindfulness-Based Stress Reduction (MSBR)

Psychoeducational Support Group (PE) BEHAVIORAL

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.

Psychoeducational Support Group (PE)

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Loma Linda University: lead
• California State University, Fullerton: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Loma Linda University

Loma Linda, California, 92350, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Limitations and Caveats

The onset of the COVID-19 pandemic and associated restrictions on in-person activities changed our procedures mid-study and likely impacted parents' stress levels and experiences in the interventions. Additionally, while the use of an active comparator was a significant strength of the study's design, we did not have a no-intervention control group and therefore we cannot evaluate the benefit of the MSBR of PE interventions relative to normative changes in parenting stress over time.

Results Point of Contact

• Title: Cameron Leigh Neece
• Organization: Loma Linda University

cneece@llu.edu

909 558 4000

Study Officials

• Cameron L Neece, Ph.D.

  Loma Linda University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: February 28, 2018
• First Posted: March 9, 2018
• Study Start: July 21, 2018
• Primary Completion: June 28, 2022
• Study Completion: June 28, 2022
• Last Updated: November 13, 2023
• Results First Posted: November 13, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)