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

Autism Spectrum Disorder Clinical Trial

— ASD  

Official title:

Mindfulness and Parent Stress Reduction: Improving Outcomes for Children With Autism Spectrum Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03459625
• Other study ID #: 5110264
• Status: Completed
• Phase: N/A
• Start date: July 21, 2018
• Est. completion date: June 28, 2022

Study information

• Verified date: November 2023
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: June 28, 2022
• Est. primary completion date: June 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Loma Linda University	Loma Linda	California

Sponsors (3)

Lead Sponsor	Collaborator
Loma Linda University	California State University, Fullerton, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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)
Primary	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
Primary	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	Parenting Stress	Assessment will be based in parent participant reports on the Parental Distress sub-scale of the Parenting Stress Index-Fourth Edition, Short Form. The Parenting Stress Index includes 36 items that are rated on a five-point scale that ranges from 1 (strongly agree) to 5 (strongly disagree). Scores on the Parental Distress sub-scale of the Parenting Stress Index-Fourth Edition, Short Form range from 12 to 60, with higher scores indicating more parental distress.	Baseline
Secondary	Parenting Stress	Assessment will be based in parent participant reports on the Parental Distress sub-scale of the Parenting Stress Index-Fourth Edition, Short Form. The Parenting Stress Index includes 36 items that are rated on a five-point scale that ranges from 1 (strongly agree) to 5 (strongly disagree). Scores on the Parental Distress sub-scale of the Parenting Stress Index-Fourth Edition, Short Form range from 12 to 60, with higher scores indicating more parental distress.	Within 4 weeks of completing last intervention session (session 8)
Secondary	Parenting Stress	Assessment will be based in parent participant reports on the Parental Distress sub-scale of the Parenting Stress Index-Fourth Edition, Short Form. The Parenting Stress Index includes 36 items that are rated on a five-point scale that ranges from 1 (strongly agree) to 5 (strongly disagree). Scores on the Parental Distress sub-scale of the Parenting Stress Index-Fourth Edition, Short Form range from 12 to 60, with higher scores indicating more parental distress.	6-month follow-up visit
Secondary	Parenting Stress	Assessment will be based in parent participant reports on the Parental Distress sub-scale of the Parenting Stress Index-Fourth Edition, Short Form. The Parenting Stress Index includes 36 items that are rated on a five-point scale that ranges from 1 (strongly agree) to 5 (strongly disagree). Scores on the Parental Distress sub-scale of the Parenting Stress Index-Fourth Edition, Short Form range from 12 to 60, with higher scores indicating more parental distress.	12-month follow-up visit