Mindfulness-Enhanced Pivotal Response Group Treatment on Parenting Stress

Sponsor
Virginia Polytechnic Institute and State University (Other)
Overall Status
Completed
CT.gov ID
NCT05948202
Collaborator
(none)
15
1
2
33.8
0.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Pivotal Response Treatment
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
15 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
randomized controlled trialrandomized controlled trial
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Impact of Mindfulness-Enhanced Pivotal Response Group Treatment on Parenting Stress: A Randomized Controlled Trial
Actual Study Start Date :
Apr 10, 2017
Actual Primary Completion Date :
Feb 4, 2020
Actual Study Completion Date :
Feb 4, 2020

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. Therapist fidelity observation [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)

  2. Child utterances - observation [pre-treatment at intake]

    level or amount of child utterances during a structured laboratory task observation

  3. Child utterances - observation [mid-treatment, at 6 weeks from start of treatment]

    level or amount of child utterances during a structured laboratory task observation

  4. Child utterances - observation [weekly, from start of treatment through 12 weeks]

    level or amount of child utterances during a structured laboratory task observation

  5. Child utterances - observation [post-treatment, at 12 weeks from start of treatment]

    level or amount of child utterances during a structured laboratory task observation

  6. Child utterances - observation [follow-up, at 3 months after the last treatment session]

    level or amount of child utterances during a structured laboratory task observation

  7. Parent fidelity observation [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)

  8. Parenting Stress Index, 4th edition [pre-treatment at intake]

    level of parent-reported stress;

  9. Parenting Stress Index, 4th edition [mid-treatment, at 6 weeks from start of treatment]

    level of parent-reported stress

  10. Parenting Stress Index, 4th edition [post-treatment, at 12 weeks from start of treatment]

    level of parent-reported stress

  11. Parenting Stress Index, 4th edition [follow-up, at 3 months after last treatment session]

    level of parent-reported stress

  12. Autism Parenting Stress Index [pre-treatment at intake]

    level of parent-reported stress specific for parents of young autistic children

  13. Autism Parenting Stress Index [mid-treatment, at 6 weeks from start of treatment]

    level of parent-reported stress specific for parents of young autistic children

  14. Autism Parenting Stress Index [post-treatment, at 12 weeks from start of treatment]

    level of parent-reported stress specific for parents of young autistic children

  15. Autism Parenting Stress Index [follow-up, at 3 months after last treatment session]

    level of parent-reported stress specific for parents of young autistic children

  16. Subjective Units of Parenting Stress Scale [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

  17. Subjective Units of Parenting Stress Scale [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

  18. Subjective Units of Parenting Stress Scale [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

  19. Subjective Units of Parenting Stress Scale [follow-up, at 3 months after last treatment session]

    level of parent-reported stress immediately following the structured lab observation

Secondary Outcome Measures

  1. Parent Feelings Questionnaire [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

  2. Parent Feelings Questionnaire [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

  3. Parent Feelings Questionnaire [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

  4. Parent Feelings Questionnaire [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

  5. Positive and Negative Affect Schedule [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

  6. Positive and Negative Affect Schedule [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

  7. Positive and Negative Affect Schedule [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

  8. Positive and Negative Affect Schedule [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

  9. Five Facet Mindfulness Questionnaire [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

  10. Five Facet Mindfulness Questionnaire [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

  11. Five Facet Mindfulness Questionnaire [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

  12. Five Facet Mindfulness Questionnaire [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

  13. Acceptance and Action Questionnaire [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

  14. Child Behavior Checklist for ages 1.5 to 5 [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

  15. Child Behavior Checklist for ages 1.5 to 5 [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

  16. Child Behavior Checklist for ages 1.5 to 5 [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

Other Outcome Measures

  1. Parent Treatment Satisfaction Questionnaire [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Months to 6 Years
Sexes Eligible for Study:
All
Accepts 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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Virginia Tech Autism Clinic Blacksburg Virginia United States 24060

Sponsors and Collaborators

  • Virginia Polytechnic Institute and State University

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

Responsible Party:
Angela Scarpa-Friedman, Professor, Virginia Polytechnic Institute and State University
ClinicalTrials.gov Identifier:
NCT05948202
Other Study ID Numbers:
  • 17-079
First Posted:
Jul 17, 2023
Last Update Posted:
Jul 17, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 17, 2023