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Mindfulness-Enhanced Pivotal Response Group Treatment on Parenting Stress

Primary Purpose

Autism Spectrum Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pivotal Response Treatment
Sponsored by
Virginia Polytechnic Institute and State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder

Eligibility Criteria

18 Months - 6 Years (Child)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Virginia Tech Autism Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

mPRT

pPRT

Arm Description

mindfulness-enhanced Pivotal Response Treatment: group pivotal response training for parents that is supplemented with mindfulness strategies

psychoeducation-enhanced Pivotal Response Treatment: group pivotal response training for parents that is supplemented with psychoeducation about stress and stress reduction

Outcomes

Primary Outcome Measures

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)
Child utterances - observation
level or amount of child utterances during a structured laboratory task observation
Child utterances - observation
level or amount of child utterances during a structured laboratory task observation
Child utterances - observation
level or amount of child utterances during a structured laboratory task observation
Child utterances - observation
level or amount of child utterances during a structured laboratory task observation
Child utterances - observation
level or amount of child utterances during a structured laboratory task observation
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)
Parenting Stress Index, 4th edition
level of parent-reported stress;
Parenting Stress Index, 4th edition
level of parent-reported stress
Parenting Stress Index, 4th edition
level of parent-reported stress
Parenting Stress Index, 4th edition
level of parent-reported stress
Autism Parenting Stress Index
level of parent-reported stress specific for parents of young autistic children
Autism Parenting Stress Index
level of parent-reported stress specific for parents of young autistic children
Autism Parenting Stress Index
level of parent-reported stress specific for parents of young autistic children
Autism Parenting Stress Index
level of parent-reported stress specific for parents of young autistic children
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
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
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
Subjective Units of Parenting Stress Scale
level of parent-reported stress immediately following the structured lab observation

Secondary Outcome Measures

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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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

Full Information

First Posted
June 1, 2023
Last Updated
July 7, 2023
Sponsor
Virginia Polytechnic Institute and State University
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1. Study Identification

Unique Protocol Identification Number
NCT05948202
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
April 10, 2017 (Actual)
Primary Completion Date
February 4, 2020 (Actual)
Study Completion Date
February 4, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Virginia Polytechnic Institute and State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized controlled trial
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
mPRT
Arm Type
Experimental
Arm Description
mindfulness-enhanced Pivotal Response Treatment: group pivotal response training for parents that is supplemented with mindfulness strategies
Arm Title
pPRT
Arm Type
Active Comparator
Arm Description
psychoeducation-enhanced Pivotal Response Treatment: group pivotal response training for parents that is supplemented with psychoeducation about stress and stress reduction
Intervention Type
Behavioral
Intervention Name(s)
Pivotal Response Treatment
Intervention Description
Group-based parent training to teach parents behavioral strategies based on principles of learning to motivate their child.
Primary Outcome Measure Information:
Title
Therapist fidelity observation
Description
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)
Time Frame
weekly, from start of treatment through 12 weeks
Title
Child utterances - observation
Description
level or amount of child utterances during a structured laboratory task observation
Time Frame
pre-treatment at intake
Title
Child utterances - observation
Description
level or amount of child utterances during a structured laboratory task observation
Time Frame
mid-treatment, at 6 weeks from start of treatment
Title
Child utterances - observation
Description
level or amount of child utterances during a structured laboratory task observation
Time Frame
weekly, from start of treatment through 12 weeks
Title
Child utterances - observation
Description
level or amount of child utterances during a structured laboratory task observation
Time Frame
post-treatment, at 12 weeks from start of treatment
Title
Child utterances - observation
Description
level or amount of child utterances during a structured laboratory task observation
Time Frame
follow-up, at 3 months after the last treatment session
Title
Parent fidelity observation
Description
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)
Time Frame
weekly, from start of treatment through 12 weeks
Title
Parenting Stress Index, 4th edition
Description
level of parent-reported stress;
Time Frame
pre-treatment at intake
Title
Parenting Stress Index, 4th edition
Description
level of parent-reported stress
Time Frame
mid-treatment, at 6 weeks from start of treatment
Title
Parenting Stress Index, 4th edition
Description
level of parent-reported stress
Time Frame
post-treatment, at 12 weeks from start of treatment
Title
Parenting Stress Index, 4th edition
Description
level of parent-reported stress
Time Frame
follow-up, at 3 months after last treatment session
Title
Autism Parenting Stress Index
Description
level of parent-reported stress specific for parents of young autistic children
Time Frame
pre-treatment at intake
Title
Autism Parenting Stress Index
Description
level of parent-reported stress specific for parents of young autistic children
Time Frame
mid-treatment, at 6 weeks from start of treatment
Title
Autism Parenting Stress Index
Description
level of parent-reported stress specific for parents of young autistic children
Time Frame
post-treatment, at 12 weeks from start of treatment
Title
Autism Parenting Stress Index
Description
level of parent-reported stress specific for parents of young autistic children
Time Frame
follow-up, at 3 months after last treatment session
Title
Subjective Units of Parenting Stress Scale
Description
level of parent-reported stress immediately following the structured lab observation, with 0 signifying no stress and 100 signifying extreme stress
Time Frame
pre-treatment at intake
Title
Subjective Units of Parenting Stress Scale
Description
level of parent-reported stress immediately following the structured lab observation, with 0 signifying no stress and 100 signifying extreme stress
Time Frame
mid-treatment, at 6 weeks from start of treatment
Title
Subjective Units of Parenting Stress Scale
Description
level of parent-reported stress immediately following the structured lab observation, with 0 signifying no stress and 100 signifying extreme stress
Time Frame
post-treatment, at 12 weeks from start of treatment
Title
Subjective Units of Parenting Stress Scale
Description
level of parent-reported stress immediately following the structured lab observation
Time Frame
follow-up, at 3 months after last treatment session
Secondary Outcome Measure Information:
Title
Parent Feelings Questionnaire
Description
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
Time Frame
pre-treatment, at intake
Title
Parent Feelings Questionnaire
Description
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
Time Frame
mid-treatment, at 6 weeks from start of treatment
Title
Parent Feelings Questionnaire
Description
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
Time Frame
post-treatment, at 12 weeks from start of treatment
Title
Parent Feelings Questionnaire
Description
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
Time Frame
follow-up, at 3 months after last treatment session
Title
Positive and Negative Affect Schedule
Description
parent-reported positive and negative affect in adults; 5 point scale from very slightly to extremely; higher scores mean higher levels of the feeling
Time Frame
pre-treatment, at intake
Title
Positive and Negative Affect Schedule
Description
parent-reported positive and negative affect in adults; 5 point scale from very slightly to extremely; higher scores mean higher levels of the feeling
Time Frame
mid-treatment, at 6 weeks from start of treatment
Title
Positive and Negative Affect Schedule
Description
parent-reported positive and negative affect in adults; 5 point scale from very slightly to extremely; higher scores mean higher levels of the feeling
Time Frame
post-treatment, at 12 weeks from start of treatment
Title
Positive and Negative Affect Schedule
Description
parent-reported positive and negative affect in adults; 5 point scale from very slightly to extremely; higher scores mean higher levels of the feeling
Time Frame
follow-up, at 3 months after last treatment session
Title
Five Facet Mindfulness Questionnaire
Description
parent-reported propensity toward mindfulness in everyday life; 5 point scale from never true to always true; higher scores mean more mindfulness
Time Frame
pre-treatment, at intake
Title
Five Facet Mindfulness Questionnaire
Description
parent-reported propensity toward mindfulness in everyday life; 5 point scale from never true to always true; higher scores mean more mindfulness
Time Frame
mid-treatment, at 6 weeks from start of treatment
Title
Five Facet Mindfulness Questionnaire
Description
parent-reported propensity toward mindfulness in everyday life; 5 point scale from never true to always true; higher scores mean more mindfulness
Time Frame
post-treatment, at 12 weeks from start of treatment
Title
Five Facet Mindfulness Questionnaire
Description
parent-reported propensity toward mindfulness in everyday life; 5 point scale from never true to always true; higher scores mean more mindfulness
Time Frame
follow-up, at 3 months after last treatment session
Title
Acceptance and Action Questionnaire
Description
parent-reported level of experiential avoidance, on a 7 point scale from never true to always true; higher scores indicate more avoidance
Time Frame
pre-treatment, at intake
Title
Child Behavior Checklist for ages 1.5 to 5
Description
parent-reported measure of child emotional and behavioral concerns; converted to t-scores; higher scores indicate higher levels of the behavior problem
Time Frame
mid-treatment, at 6 weeks from start of treatment
Title
Child Behavior Checklist for ages 1.5 to 5
Description
parent-reported measure of child emotional and behavioral concerns; converted to t-scores; higher scores indicate higher levels of the behavior problem
Time Frame
post-treatment, at 12 weeks from start of treatment
Title
Child Behavior Checklist for ages 1.5 to 5
Description
parent-reported measure of child emotional and behavioral concerns; converted to t-scores; higher scores indicate higher levels of the behavior problem
Time Frame
follow-up, at 3 months after last treatment session
Other Pre-specified Outcome Measures:
Title
Parent Treatment Satisfaction Questionnaire
Description
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.
Time Frame
post-treatment, at 12 weeks from start of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Months
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Facility Information:
Facility Name
Virginia Tech Autism Clinic
City
Blacksburg
State/Province
Virginia
ZIP/Postal Code
24060
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The de-identified data are shared with other members of the research team.
Citations:
PubMed Identifier
22790429
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.
Results Reference
background
PubMed Identifier
18027079
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.
Results Reference
background

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Mindfulness-Enhanced Pivotal Response Group Treatment on Parenting Stress

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