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Mindfulness-Enhanced Pivotal Response Group Treatment on Parenting Stress

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05948202
Enrollment
15
Registered
2023-07-17
Start date
2017-04-10
Completion date
2020-02-04
Last updated
2023-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorder

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.

Interventions

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

Sponsors

Virginia Polytechnic Institute and State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Intervention model description

randomized controlled trial

Eligibility

Sex/Gender
ALL
Age
18 Months to 6 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Subjective Units of Parenting Stress Scalepre-treatment at intakelevel of parent-reported stress immediately following the structured lab observation, with 0 signifying no stress and 100 signifying extreme stress
Therapist fidelity observationweekly, from start of treatment through 12 weeksobservation 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 - observationpre-treatment at intakelevel or amount of child utterances during a structured laboratory task observation
Parent fidelity observationweekly, from start of treatment through 12 weeksobservation 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 editionpre-treatment at intakelevel of parent-reported stress;
Autism Parenting Stress Indexpre-treatment at intakelevel of parent-reported stress specific for parents of young autistic children

Secondary

MeasureTime frameDescription
Parent Feelings Questionnairepre-treatment, at intakeparent-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 Schedulepre-treatment, at intakeparent-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 Questionnairepre-treatment, at intakeparent-reported propensity toward mindfulness in everyday life; 5 point scale from never true to always true; higher scores mean more mindfulness
Acceptance and Action Questionnairepre-treatment, at intakeparent-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 5mid-treatment, at 6 weeks from start of treatmentparent-reported measure of child emotional and behavioral concerns; converted to t-scores; higher scores indicate higher levels of the behavior problem

Other

MeasureTime frameDescription
Parent Treatment Satisfaction Questionnairepost-treatment, at 12 weeks from start of treatmentParent-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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026