Mindfulness-Enhanced Pivotal Response Group Treatment on Parenting Stress

NCT ID: NCT05948202

Last Updated: 2023-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-10

Study Completion Date

2020-02-04

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.

Conditions

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Autism Spectrum Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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mPRT

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

Group Type EXPERIMENTAL

Pivotal Response Treatment

Intervention Type BEHAVIORAL

Group-based parent training to teach parents behavioral strategies based on principles of learning to motivate their child.

pPRT

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

Group Type ACTIVE_COMPARATOR

Pivotal Response Treatment

Intervention Type BEHAVIORAL

Group-based parent training to teach parents behavioral strategies based on principles of learning to motivate their child.

Interventions

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Pivotal Response Treatment

Group-based parent training to teach parents behavioral strategies based on principles of learning to motivate their child.

Intervention Type BEHAVIORAL

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)
Minimum Eligible Age

18 Months

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Virginia Polytechnic Institute and State University

OTHER

Sponsor Role lead

Responsible Party

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Angela Scarpa-Friedman

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Virginia Tech Autism Clinic

Blacksburg, Virginia, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 22790429 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18027079 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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17-079

Identifier Type: -

Identifier Source: org_study_id

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