Mindfulness-Enhanced Pivotal Response Group Treatment on Parenting Stress

July 7, 2023 updated by: Angela Scarpa-Friedman, Virginia Polytechnic Institute and State University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Blacksburg, Virginia, United States, 24060
        • Virginia Tech Autism Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: mPRT
mindfulness-enhanced Pivotal Response Treatment: group pivotal response training for parents that is supplemented with mindfulness strategies
Behavioral: Pivotal Response Treatment
Group-based parent training to teach parents behavioral strategies based on principles of learning to motivate their child.
Active Comparator: pPRT
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Therapist fidelity observation
Time Frame: weekly, from start of treatment through 12 weeks
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
Time Frame: pre-treatment at intake
level or amount of child utterances during a structured laboratory task observation
pre-treatment at intake
Child utterances - observation
Time Frame: mid-treatment, at 6 weeks from start of treatment
level or amount of child utterances during a structured laboratory task observation
mid-treatment, at 6 weeks from start of treatment
Child utterances - observation
Time Frame: weekly, from start of treatment through 12 weeks
level or amount of child utterances during a structured laboratory task observation
weekly, from start of treatment through 12 weeks
Child utterances - observation
Time Frame: post-treatment, at 12 weeks from start of treatment
level or amount of child utterances during a structured laboratory task observation
post-treatment, at 12 weeks from start of treatment
Child utterances - observation
Time Frame: follow-up, at 3 months after the last treatment session
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
Time Frame: weekly, from start of treatment through 12 weeks
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
Time Frame: pre-treatment at intake
level of parent-reported stress;
pre-treatment at intake
Parenting Stress Index, 4th edition
Time Frame: mid-treatment, at 6 weeks from start of treatment
level of parent-reported stress
mid-treatment, at 6 weeks from start of treatment
Parenting Stress Index, 4th edition
Time Frame: post-treatment, at 12 weeks from start of treatment
level of parent-reported stress
post-treatment, at 12 weeks from start of treatment
Parenting Stress Index, 4th edition
Time Frame: follow-up, at 3 months after last treatment session
level of parent-reported stress
follow-up, at 3 months after last treatment session
Autism Parenting Stress Index
Time Frame: pre-treatment at intake
level of parent-reported stress specific for parents of young autistic children
pre-treatment at intake
Autism Parenting Stress Index
Time Frame: mid-treatment, at 6 weeks from start of treatment
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
Time Frame: post-treatment, at 12 weeks from start of treatment
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
Time Frame: follow-up, at 3 months after last treatment session
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
Time Frame: pre-treatment at intake
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
Time Frame: mid-treatment, at 6 weeks from start of treatment
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
Time Frame: post-treatment, at 12 weeks from start of treatment
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
Time Frame: follow-up, at 3 months after last treatment session
level of parent-reported stress immediately following the structured lab observation
follow-up, at 3 months after last treatment session

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Parent Feelings Questionnaire
Time Frame: pre-treatment, at intake
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
pre-treatment, at intake
Parent Feelings Questionnaire
Time Frame: mid-treatment, at 6 weeks from start of treatment
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
mid-treatment, at 6 weeks from start of treatment
Parent Feelings Questionnaire
Time Frame: post-treatment, at 12 weeks from start of treatment
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
post-treatment, at 12 weeks from start of treatment
Parent Feelings Questionnaire
Time Frame: follow-up, at 3 months after last treatment session
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
follow-up, at 3 months after last treatment session
Positive and Negative Affect Schedule
Time Frame: pre-treatment, at intake
parent-reported positive and negative affect in adults; 5 point scale from very slightly to extremely; higher scores mean higher levels of the feeling
pre-treatment, at intake
Positive and Negative Affect Schedule
Time Frame: mid-treatment, at 6 weeks from start of treatment
parent-reported positive and negative affect in adults; 5 point scale from very slightly to extremely; higher scores mean higher levels of the feeling
mid-treatment, at 6 weeks from start of treatment
Positive and Negative Affect Schedule
Time Frame: post-treatment, at 12 weeks from start of treatment
parent-reported positive and negative affect in adults; 5 point scale from very slightly to extremely; higher scores mean higher levels of the feeling
post-treatment, at 12 weeks from start of treatment
Positive and Negative Affect Schedule
Time Frame: follow-up, at 3 months after last treatment session
parent-reported positive and negative affect in adults; 5 point scale from very slightly to extremely; higher scores mean higher levels of the feeling
follow-up, at 3 months after last treatment session
Five Facet Mindfulness Questionnaire
Time Frame: pre-treatment, at intake
parent-reported propensity toward mindfulness in everyday life; 5 point scale from never true to always true; higher scores mean more mindfulness
pre-treatment, at intake
Five Facet Mindfulness Questionnaire
Time Frame: mid-treatment, at 6 weeks from start of treatment
parent-reported propensity toward mindfulness in everyday life; 5 point scale from never true to always true; higher scores mean more mindfulness
mid-treatment, at 6 weeks from start of treatment
Five Facet Mindfulness Questionnaire
Time Frame: post-treatment, at 12 weeks from start of treatment
parent-reported propensity toward mindfulness in everyday life; 5 point scale from never true to always true; higher scores mean more mindfulness
post-treatment, at 12 weeks from start of treatment
Five Facet Mindfulness Questionnaire
Time Frame: follow-up, at 3 months after last treatment session
parent-reported propensity toward mindfulness in everyday life; 5 point scale from never true to always true; higher scores mean more mindfulness
follow-up, at 3 months after last treatment session
Acceptance and Action Questionnaire
Time Frame: pre-treatment, at intake
parent-reported level of experiential avoidance, on a 7 point scale from never true to always true; higher scores indicate more avoidance
pre-treatment, at intake
Child Behavior Checklist for ages 1.5 to 5
Time Frame: mid-treatment, at 6 weeks from start of treatment
parent-reported measure of child emotional and behavioral concerns; converted to t-scores; higher scores indicate higher levels of the behavior problem
mid-treatment, at 6 weeks from start of treatment
Child Behavior Checklist for ages 1.5 to 5
Time Frame: post-treatment, at 12 weeks from start of treatment
parent-reported measure of child emotional and behavioral concerns; converted to t-scores; higher scores indicate higher levels of the behavior problem
post-treatment, at 12 weeks from start of treatment
Child Behavior Checklist for ages 1.5 to 5
Time Frame: follow-up, at 3 months after last treatment session
parent-reported measure of child emotional and behavioral concerns; converted to t-scores; higher scores indicate higher levels of the behavior problem
follow-up, at 3 months after last treatment session

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Parent Treatment Satisfaction Questionnaire
Time Frame: post-treatment, at 12 weeks from start of treatment
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.
post-treatment, at 12 weeks from start of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Virginia Polytechnic Institute and State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 10, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 4, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 4, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 1, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 7, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 17, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 17, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 7, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 17-079

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The de-identified data are shared with other members of the research team.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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