Impact of Mindfulness-Enhanced Pivotal Response Group Treatment on Parenting Stress: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 15
- Locations
- 2
- Primary Endpoint
- Therapist fidelity observation
Study Overview
Brief Summary
This project tests the feasibility and preliminary proof of concept for a mindfulness-enhanced adaptation of Pivotal Response Treatment on parenting stress and child communication, using a randomized controlled design.
Detailed Description
One of the core features of Autism Spectrum Disorder (ASD), social communication impairment, presents in a variety of ways, including reduced functional language use and social initiations, which often warrant intensive intervention services. Additionally, parents of children with ASD demonstrate increased levels of parenting stress when compared to parents of typically developing children and children with developmental delays. Elevated parenting stress has been shown to diminish positive treatment outcomes, which lends support to develop methodologies to concomitantly target child and parent behaviors. The current randomized control trial (RCT) uses a dual-pronged approach to directly target both child communication deficits and parenting stress within a group format. This RCT combined an empirically supported behavioral therapy, Pivotal Response Treatment (PRT), with components from Acceptance and Commitment Therapy and Mindful Parenting for reducing parenting stress. Caregivers and their minimally or pre-verbal child with diagnosed or suspected ASD were randomly assigned to one of the following supplemental conditions: mindfulness-enhanced PRT (mPRT) or psychoeducation-enhanced PRT (pPRT) as an active control condition. The current study assessed feasibility and acceptability in addition to demonstrating proof of concept in regard to additive effects of mPRT compared to pPRT.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Months to 6 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •For children: minimally verbal or nonverbal, 1.5 to 6 years old, current or suspected autism spectrum disorder diagnosis, demonstrated ability to make meaningful vocalizations
- •For parents: willingness to attend group treatment sessions, record weekly videos, and share videos in a group setting
Exclusion Criteria
- •For children, no active medical problems (e.g., unstable seizure disorders)
- •For parents, no severe mental health problems (e.g., suicidal intent, psychosis)
Outcomes
Primary Outcomes
Therapist fidelity observation
Time Frame: weekly, from start of treatment through 12 weeks
observation at 30-second intervals; number out of 10 pivotal response therapy components observed for each 30-second interval of the recording and then averaged over the length of the recording (which were 5-10 minutes long)
Child utterances - observation
Time Frame: follow-up, at 3 months after the last treatment session
level or amount of child utterances during a structured laboratory task observation
Parent fidelity observation
Time Frame: weekly, from start of treatment through 12 weeks
observation at 30-second intervals; number out of 10 pivotal response therapy components observed for each 30-second interval of the recording and then averaged over the length of the recording (which were 5-10 minutes long)
Parenting Stress Index, 4th edition
Time Frame: follow-up, at 3 months after last treatment session
level of parent-reported stress
Autism Parenting Stress Index
Time Frame: follow-up, at 3 months after last treatment session
level of parent-reported stress specific for parents of young autistic children
Subjective Units of Parenting Stress Scale
Time Frame: follow-up, at 3 months after last treatment session
level of parent-reported stress immediately following the structured lab observation
Secondary Outcomes
- Parent Feelings Questionnaire(follow-up, at 3 months after last treatment session)
- Five Facet Mindfulness Questionnaire(follow-up, at 3 months after last treatment session)
- Positive and Negative Affect Schedule(follow-up, at 3 months after last treatment session)
- Acceptance and Action Questionnaire(pre-treatment, at intake)
- Child Behavior Checklist for ages 1.5 to 5(follow-up, at 3 months after last treatment session)
Investigators
Angela Scarpa-Friedman
Professor
Virginia Polytechnic Institute and State University