An interventional study of Pivotal Response Treatment in Autism Spectrum Disorder, sponsored by Virginia Polytechnic Institute and State University. Completed at 1 site in United States. Open to participants aged 18 Months to 6 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-17.
Sponsored by Virginia Polytechnic Institute and State University · Not applicable, Interventional, and Treatment
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.
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.
1,727 studies on the registry are indexed under Autism Spectrum Disorder; 504 are open to participants now.
This study's enrollment of 15 is below the median of 52 across 1,370 interventional studies indexed under Autism Spectrum Disorder.
Browse Autism Spectrum Disorder studies →Virginia Polytechnic Institute and State University is the lead sponsor of 124 studies on the registry; 27 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
mindfulness-enhanced Pivotal Response Treatment: group pivotal response training for parents that is supplemented with mindfulness strategies
Behavioral: Pivotal Response Treatment
psychoeducation-enhanced Pivotal Response Treatment: group pivotal response training for parents that is supplemented with psychoeducation about stress and stress reduction
Behavioral: Pivotal Response Treatment
Group-based parent training to teach parents behavioral strategies based on principles of learning to motivate their child.
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)
Time frame: weekly, from start of treatment through 12 weeks
Child utterances - observation
level or amount of child utterances during a structured laboratory task observation
Time frame: pre-treatment at intake
Child utterances - observation
level or amount of child utterances during a structured laboratory task observation
Time frame: mid-treatment, at 6 weeks from start of treatment
Child utterances - observation
level or amount of child utterances during a structured laboratory task observation
Time frame: weekly, from start of treatment through 12 weeks
Child utterances - observation
level or amount of child utterances during a structured laboratory task observation
Time frame: post-treatment, at 12 weeks from start of treatment
Child utterances - observation
level or amount of child utterances during a structured laboratory task observation
Time frame: 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)
Time frame: weekly, from start of treatment through 12 weeks
Parenting Stress Index, 4th edition
level of parent-reported stress;
Time frame: pre-treatment at intake
Parenting Stress Index, 4th edition
level of parent-reported stress
Time frame: mid-treatment, at 6 weeks from start of treatment
Parenting Stress Index, 4th edition
level of parent-reported stress
Time frame: post-treatment, at 12 weeks from start of treatment
Parenting Stress Index, 4th edition
level of parent-reported stress
Time frame: 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
Time frame: pre-treatment at intake
Autism Parenting Stress Index
level of parent-reported stress specific for parents of young autistic children
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: follow-up, at 3 months after last treatment session
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
Time frame: pre-treatment, at intake
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
Time frame: mid-treatment, at 6 weeks from start of treatment
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
Time frame: post-treatment, at 12 weeks from start of treatment
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
Time frame: follow-up, at 3 months after last treatment session
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
Time frame: pre-treatment, at intake
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
Time frame: mid-treatment, at 6 weeks from start of treatment
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
Time frame: post-treatment, at 12 weeks from start of treatment
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
Time frame: follow-up, at 3 months after last treatment session
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
Time frame: pre-treatment, at intake
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
Time frame: mid-treatment, at 6 weeks from start of treatment
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
Time frame: post-treatment, at 12 weeks from start of treatment
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
Time frame: follow-up, at 3 months after last treatment session
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
Time frame: pre-treatment, at intake
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
Time frame: mid-treatment, at 6 weeks from start of treatment
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
Time frame: post-treatment, at 12 weeks from start of treatment
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
Time frame: follow-up, at 3 months after last treatment session
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.
Time frame: post-treatment, at 12 weeks from start of treatment
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — The de-identified data are shared with other members of the research team.
Supporting information: Study protocol, Sap
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Virginia Polytechnic Institute and State University