Clinical trial NCT03459625: Mindfulness for Parents of Children With Autism Spectrum Disorder Autism Spectrum Disorder
Official title: Mindfulness and Parent Stress Reduction: Improving Outcomes for Children With Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Lead sponsor: Loma Linda University
Sponsor class: OTHER
Collaborators: name: California State University, Fullerton
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2018-03-09
Enrollment: 118
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Child Externalizing Behavior Problems as Evidenced by Reductions in the Externalizing Scores on a Standardized Parent-report Questionnaire.
timeFrame: At baseline
measure: Child Externalizing Behavior Problems as Evidenced by Reductions in the Externalizing Score on a Standardized Parent-report Questionnaire.
timeFrame: Within 4 weeks of completing last intervention session (session 8)
measure: Child Externalizing Behavior Problems as Evidenced by Reductions in the Externalizing Score on a Standardized Parent-report Questionnaire.
timeFrame: 6-month follow-up visit
measure: Child Externalizing Behavior Problems as Evidenced by Reductions in the Externalizing Score on a Standardized Parent-report Questionnaire.
timeFrame: 12-month follow-up visit
Secondary outcomes:
measure: Parenting Stress
timeFrame: Baseline
measure: Parenting Stress
timeFrame: Within 4 weeks of completing last intervention session (session 8)
measure: Parenting Stress
timeFrame: 6-month follow-up visit
measure: Parenting Stress
timeFrame: 12-month follow-up visit
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University
state: California
Study officials:
affiliation: Loma Linda University
name: Cameron L Neece, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: