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Completed

NCT Number: NCT05948202

Mindfulness-Enhanced Pivotal Response Group Treatment on Parenting Stress

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.

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Key information

Conditions

Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

18 month–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Virginia Tech Autism Clinic

Blacksburg, Virginia, 24060, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Pivotal Response Treatment

Behavioral

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

Primary outcomes

  1. 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)

  2. Child utterances - observation

    Time frame: pre-treatment at intake

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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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)

  8. Parenting Stress Index, 4th edition

    Time frame: pre-treatment at intake

    level of parent-reported stress;

  9. Parenting Stress Index, 4th edition

    Time frame: mid-treatment, at 6 weeks from start of treatment

    level of parent-reported stress

  10. Parenting Stress Index, 4th edition

    Time frame: post-treatment, at 12 weeks from start of treatment

    level of parent-reported stress

  11. Parenting Stress Index, 4th edition

    Time frame: follow-up, at 3 months after last treatment session

    level of parent-reported stress

  12. Autism Parenting Stress Index

    Time frame: pre-treatment at intake

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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Virginia Polytechnic Institute and State University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jul 17, 2023
Registry last updated
Jul 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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