Mindfulness-Enhanced Pivotal Response Group Treatment on Parenting Stress

Study Overview
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Brief Summary
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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
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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.

Official Title
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Impact of Mindfulness-Enhanced Pivotal Response Group Treatment on Parenting Stress: A Randomized Controlled Trial

Conditions
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Autism Spectrum Disorder

Intervention / Treatment
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* Behavioral: Pivotal Response Treatment


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Months
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized controlled trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mPRT<br>mindfulness-enhanced Pivotal Response Treatment: group pivotal response training for parents that is supplemented with mindfulness strategies | Behavioral: Pivotal Response Treatment<br>* Group-based parent training to teach parents behavioral strategies based on principles of learning to motivate their child.<br>|
| Active Comparator: pPRT<br>psychoeducation-enhanced Pivotal Response Treatment: group pivotal response training for parents that is supplemented with psychoeducation about stress and stress reduction | Behavioral: Pivotal Response Treatment<br>* Group-based parent training to teach parents behavioral strategies based on principles of learning to motivate their child.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Therapist fidelity observation | 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) | weekly, from start of treatment through 12 weeks | 
| Child utterances - observation | level or amount of child utterances during a structured laboratory task observation | pre-treatment at intake | 
| Child utterances - observation | level or amount of child utterances during a structured laboratory task observation | mid-treatment, at 6 weeks from start of treatment | 
| Child utterances - observation | level or amount of child utterances during a structured laboratory task observation | weekly, from start of treatment through 12 weeks | 
| Child utterances - observation | level or amount of child utterances during a structured laboratory task observation | post-treatment, at 12 weeks from start of treatment | 
| Child utterances - observation | level or amount of child utterances during a structured laboratory task observation | follow-up, at 3 months after the last treatment session | 
| Parent fidelity observation | 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) | weekly, from start of treatment through 12 weeks | 
| Parenting Stress Index, 4th edition | level of parent-reported stress; | pre-treatment at intake | 
| Parenting Stress Index, 4th edition | level of parent-reported stress | mid-treatment, at 6 weeks from start of treatment | 
| Parenting Stress Index, 4th edition | level of parent-reported stress | post-treatment, at 12 weeks from start of treatment | 
| Parenting Stress Index, 4th edition | level of parent-reported stress | follow-up, at 3 months after last treatment session | 
| Autism Parenting Stress Index | level of parent-reported stress specific for parents of young autistic children | pre-treatment at intake | 
| Autism Parenting Stress Index | level of parent-reported stress specific for parents of young autistic children | mid-treatment, at 6 weeks from start of treatment | 
| Autism Parenting Stress Index | level of parent-reported stress specific for parents of young autistic children | post-treatment, at 12 weeks from start of treatment | 
| Autism Parenting Stress Index | level of parent-reported stress specific for parents of young autistic children | follow-up, at 3 months after last treatment session | 
| Subjective Units of Parenting Stress Scale | level of parent-reported stress immediately following the structured lab observation, with 0 signifying no stress and 100 signifying extreme stress | pre-treatment at intake | 
| Subjective Units of Parenting Stress Scale | level of parent-reported stress immediately following the structured lab observation, with 0 signifying no stress and 100 signifying extreme stress | mid-treatment, at 6 weeks from start of treatment | 
| Subjective Units of Parenting Stress Scale | level of parent-reported stress immediately following the structured lab observation, with 0 signifying no stress and 100 signifying extreme stress | post-treatment, at 12 weeks from start of treatment | 
| Subjective Units of Parenting Stress Scale | level of parent-reported stress immediately following the structured lab observation | follow-up, at 3 months after last treatment session | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parent Feelings Questionnaire | parent-report of positive and negative feelings toward the child; 5 point scale from definitely untrue for me to definitely true for me; higher scores mean higher levels of the feeling | pre-treatment, at intake | 
| Parent Feelings Questionnaire | parent-report of positive and negative feelings toward the child; 5 point scale from definitely untrue for me to definitely true for me; higher scores mean higher levels of the feeling | mid-treatment, at 6 weeks from start of treatment | 
| Parent Feelings Questionnaire | parent-report of positive and negative feelings toward the child; 5 point scale from definitely untrue for me to definitely true for me; higher scores mean higher levels of the feeling | post-treatment, at 12 weeks from start of treatment | 
| Parent Feelings Questionnaire | parent-report of positive and negative feelings toward the child; 5 point scale from definitely untrue for me to definitely true for me; higher scores mean higher levels of the feeling | follow-up, at 3 months after last treatment session | 
| Positive and Negative Affect Schedule | parent-reported positive and negative affect in adults; 5 point scale from very slightly to extremely; higher scores mean higher levels of the feeling | pre-treatment, at intake | 
| Positive and Negative Affect Schedule | parent-reported positive and negative affect in adults; 5 point scale from very slightly to extremely; higher scores mean higher levels of the feeling | mid-treatment, at 6 weeks from start of treatment | 
| Positive and Negative Affect Schedule | parent-reported positive and negative affect in adults; 5 point scale from very slightly to extremely; higher scores mean higher levels of the feeling | post-treatment, at 12 weeks from start of treatment | 
| Positive and Negative Affect Schedule | parent-reported positive and negative affect in adults; 5 point scale from very slightly to extremely; higher scores mean higher levels of the feeling | follow-up, at 3 months after last treatment session | 
| Five Facet Mindfulness Questionnaire | parent-reported propensity toward mindfulness in everyday life; 5 point scale from never true to always true; higher scores mean more mindfulness | pre-treatment, at intake | 
| Five Facet Mindfulness Questionnaire | parent-reported propensity toward mindfulness in everyday life; 5 point scale from never true to always true; higher scores mean more mindfulness | mid-treatment, at 6 weeks from start of treatment | 
| Five Facet Mindfulness Questionnaire | parent-reported propensity toward mindfulness in everyday life; 5 point scale from never true to always true; higher scores mean more mindfulness | post-treatment, at 12 weeks from start of treatment | 
| Five Facet Mindfulness Questionnaire | parent-reported propensity toward mindfulness in everyday life; 5 point scale from never true to always true; higher scores mean more mindfulness | follow-up, at 3 months after last treatment session | 
| Acceptance and Action Questionnaire | parent-reported level of experiential avoidance, on a 7 point scale from never true to always true; higher scores indicate more avoidance | pre-treatment, at intake | 
| Child Behavior Checklist for ages 1.5 to 5 | parent-reported measure of child emotional and behavioral concerns; converted to t-scores; higher scores indicate higher levels of the behavior problem | mid-treatment, at 6 weeks from start of treatment | 
| Child Behavior Checklist for ages 1.5 to 5 | parent-reported measure of child emotional and behavioral concerns; converted to t-scores; higher scores indicate higher levels of the behavior problem | post-treatment, at 12 weeks from start of treatment | 
| Child Behavior Checklist for ages 1.5 to 5 | parent-reported measure of child emotional and behavioral concerns; converted to t-scores; higher scores indicate higher levels of the behavior problem | follow-up, at 3 months after last treatment session |