Mindfulness-Enhanced Pivotal Response Group Treatment on Parenting Stress
Impact of Mindfulness-Enhanced Pivotal Response Group Treatment on Parenting Stress: A Randomized Controlled Trial
1 other identifier
interventional
15
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 10, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 4, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 4, 2020
CompletedFirst Submitted
Initial submission to the registry
June 1, 2023
CompletedFirst Posted
Study publicly available on registry
July 17, 2023
CompletedJuly 17, 2023
July 1, 2023
2.8 years
June 1, 2023
July 7, 2023
Conditions
Outcome Measures
Primary Outcomes (19)
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 Outcomes (16)
Parent Feelings Questionnaire
pre-treatment, at intake
Parent Feelings Questionnaire
mid-treatment, at 6 weeks from start of treatment
Parent Feelings Questionnaire
post-treatment, at 12 weeks from start of treatment
Parent Feelings Questionnaire
follow-up, at 3 months after last treatment session
Positive and Negative Affect Schedule
pre-treatment, at intake
- +11 more secondary outcomes
Other Outcomes (1)
Parent Treatment Satisfaction Questionnaire
post-treatment, at 12 weeks from start of treatment
Study Arms (2)
mPRT
EXPERIMENTALmindfulness-enhanced Pivotal Response Treatment: group pivotal response training for parents that is supplemented with mindfulness strategies
pPRT
ACTIVE COMPARATORpsychoeducation-enhanced Pivotal Response Treatment: group pivotal response training for parents that is supplemented with psychoeducation about stress and stress reduction
Interventions
Group-based parent training to teach parents behavioral strategies based on principles of learning to motivate their child.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- For children, no active medical problems (e.g., unstable seizure disorders)
- For parents, no severe mental health problems (e.g., suicidal intent, psychosis)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Virginia Tech Autism Clinic
Blacksburg, Virginia, 24060, United States
Related 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.
PMID: 22790429BACKGROUNDOsborne 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.
PMID: 18027079BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 1, 2023
First Posted
July 17, 2023
Study Start
April 10, 2017
Primary Completion
February 4, 2020
Study Completion
February 4, 2020
Last Updated
July 17, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
The de-identified data are shared with other members of the research team.