Mindfulness-Enhanced Pivotal Response Group Treatment on Parenting Stress

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

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.

Study Overview

• Status: Completed
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Behavioral: Pivotal Response Treatment

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 Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Blacksburg, Virginia, United States, 24060
      • Virginia Tech Autism Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: mPRT; mindfulness-enhanced Pivotal Response Treatment: group pivotal response training for parents that is supplemented with mindfulness strategies	Behavioral: Pivotal Response Treatment; Group-based parent training to teach parents behavioral strategies based on principles of learning to motivate their child.
Active Comparator: pPRT; 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; Group-based parent training to teach parents behavioral strategies based on principles of learning to motivate their child.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parent Treatment Satisfaction Questionnaire	Parent-reported satisfaction with the treatment protocol on a 5 point scale from would not recommend to strongly recommend; not at all helpful to very helpful; not at all difficult to very difficult; and too few sessions to too many sessions.	post-treatment, at 12 weeks from start of treatment

Collaborators and Investigators

• Sponsor: Virginia Polytechnic Institute and State University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2017
• Primary Completion (Actual): February 4, 2020
• Study Completion (Actual): February 4, 2020

Study Registration Dates

• First Submitted: June 1, 2023
• First Submitted That Met QC Criteria: July 7, 2023
• First Posted (Actual): July 17, 2023

Study Record Updates

• Last Update Posted (Actual): July 17, 2023
• Last Update Submitted That Met QC Criteria: July 7, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder
• Other Study ID Numbers: 17-079

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The de-identified data are shared with other members of the research team.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No