Mindfulness-Enhanced Pivotal Response Group Treatment on Parenting Stress

Autism Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05948202
• Other study ID #: 17-079
• Status: Completed
• Phase: N/A
• Start date: April 10, 2017
• Est. completion date: February 4, 2020

Study information

• Verified date: July 2023
• Source: Virginia Polytechnic Institute and State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: February 4, 2020
• Est. primary completion date: February 4, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Months to 6 Years

Eligibility

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)

Related Conditions & MeSH terms

• Autism Spectrum Disorder

Intervention

Behavioral:
• Pivotal Response Treatment
Group-based parent training to teach parents behavioral strategies based on principles of learning to motivate their child.

Locations

Country	Name	City	State
United States	Virginia Tech Autism Clinic	Blacksburg	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Polytechnic Institute and State University

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Primary	Child utterances - observation	level or amount of child utterances during a structured laboratory task observation	pre-treatment at intake
Primary	Child utterances - observation	level or amount of child utterances during a structured laboratory task observation	mid-treatment, at 6 weeks from start of treatment
Primary	Child utterances - observation	level or amount of child utterances during a structured laboratory task observation	weekly, from start of treatment through 12 weeks
Primary	Child utterances - observation	level or amount of child utterances during a structured laboratory task observation	post-treatment, at 12 weeks from start of treatment
Primary	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
Primary	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
Primary	Parenting Stress Index, 4th edition	level of parent-reported stress;	pre-treatment at intake
Primary	Parenting Stress Index, 4th edition	level of parent-reported stress	mid-treatment, at 6 weeks from start of treatment
Primary	Parenting Stress Index, 4th edition	level of parent-reported stress	post-treatment, at 12 weeks from start of treatment
Primary	Parenting Stress Index, 4th edition	level of parent-reported stress	follow-up, at 3 months after last treatment session
Primary	Autism Parenting Stress Index	level of parent-reported stress specific for parents of young autistic children	pre-treatment at intake
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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