Clinical trial NCT05948202: Mindfulness-Enhanced Pivotal Response Group Treatment on Parenting Stress
Official title: Impact of Mindfulness-Enhanced Pivotal Response Group Treatment on Parenting Stress: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Lead sponsor: Virginia Polytechnic Institute and State University
Sponsor class: OTHER
First posted: 2023-07-17
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Therapist fidelity observation
timeFrame: weekly, from start of treatment through 12 weeks
measure: Child utterances - observation
timeFrame: pre-treatment at intake
measure: Child utterances - observation
timeFrame: mid-treatment, at 6 weeks from start of treatment
measure: Child utterances - observation
timeFrame: weekly, from start of treatment through 12 weeks
measure: Child utterances - observation
timeFrame: post-treatment, at 12 weeks from start of treatment
measure: Child utterances - observation
timeFrame: follow-up, at 3 months after the last treatment session
measure: Parent fidelity observation
timeFrame: weekly, from start of treatment through 12 weeks
measure: Parenting Stress Index, 4th edition
timeFrame: pre-treatment at intake
measure: Parenting Stress Index, 4th edition
timeFrame: mid-treatment, at 6 weeks from start of treatment
measure: Parenting Stress Index, 4th edition
timeFrame: post-treatment, at 12 weeks from start of treatment
measure: Parenting Stress Index, 4th edition
timeFrame: follow-up, at 3 months after last treatment session
measure: Autism Parenting Stress Index
timeFrame: pre-treatment at intake
measure: Autism Parenting Stress Index
timeFrame: mid-treatment, at 6 weeks from start of treatment
measure: Autism Parenting Stress Index
timeFrame: post-treatment, at 12 weeks from start of treatment
measure: Autism Parenting Stress Index
timeFrame: follow-up, at 3 months after last treatment session
measure: Subjective Units of Parenting Stress Scale
timeFrame: pre-treatment at intake
measure: Subjective Units of Parenting Stress Scale
timeFrame: mid-treatment, at 6 weeks from start of treatment
measure: Subjective Units of Parenting Stress Scale
timeFrame: post-treatment, at 12 weeks from start of treatment
measure: Subjective Units of Parenting Stress Scale
timeFrame: follow-up, at 3 months after last treatment session
Secondary outcomes:
measure: Parent Feelings Questionnaire
timeFrame: pre-treatment, at intake
measure: Parent Feelings Questionnaire
timeFrame: mid-treatment, at 6 weeks from start of treatment
measure: Parent Feelings Questionnaire
timeFrame: post-treatment, at 12 weeks from start of treatment
measure: Parent Feelings Questionnaire
timeFrame: follow-up, at 3 months after last treatment session
measure: Positive and Negative Affect Schedule
timeFrame: pre-treatment, at intake
measure: Positive and Negative Affect Schedule
timeFrame: mid-treatment, at 6 weeks from start of treatment
measure: Positive and Negative Affect Schedule
timeFrame: post-treatment, at 12 weeks from start of treatment
measure: Positive and Negative Affect Schedule
timeFrame: follow-up, at 3 months after last treatment session
measure: Five Facet Mindfulness Questionnaire
timeFrame: pre-treatment, at intake
measure: Five Facet Mindfulness Questionnaire
timeFrame: mid-treatment, at 6 weeks from start of treatment
measure: Five Facet Mindfulness Questionnaire
timeFrame: post-treatment, at 12 weeks from start of treatment
measure: Five Facet Mindfulness Questionnaire
timeFrame: follow-up, at 3 months after last treatment session
measure: Acceptance and Action Questionnaire
timeFrame: pre-treatment, at intake
measure: Child Behavior Checklist for ages 1.5 to 5
timeFrame: mid-treatment, at 6 weeks from start of treatment
measure: Child Behavior Checklist for ages 1.5 to 5
timeFrame: post-treatment, at 12 weeks from start of treatment
measure: Child Behavior Checklist for ages 1.5 to 5
timeFrame: follow-up, at 3 months after last treatment session
Other outcomes:
measure: Parent Treatment Satisfaction Questionnaire
timeFrame: post-treatment, at 12 weeks from start of treatment
Locations:
city: Blacksburg
country: United States
facility: Virginia Tech Autism Clinic
state: Virginia
Study officials:
References:
citation: Hayes SA, Watson SL. The impact of parenting stress: a meta-analysis of studies comparing the experience of parenting stress in parents of children with and without autism spectrum disorder. J Autism Dev Disord. 2013 Mar;43(3):629-42. doi: 10.1007/s10803-012-1604-y.
citation: Osborne LA, McHugh L, Saunders J, Reed P. Parenting stress reduces the effectiveness of early teaching interventions for autistic spectrum disorders. J Autism Dev Disord. 2008 Jul;38(6):1092-103. doi: 10.1007/s10803-007-0497-7. Epub 2007 Nov 20.