Autism Spectrum DisorderNCT05948202
Mindfulness-Enhanced Pivotal Response Group Treatment on Parenting Stress
A study testing Pivotal Response Treatment in people with Autism Spectrum Disorder, run by Virginia Polytechnic Institute and State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 months to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Pivotal Response Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2017to 4 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 months to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- For children, no active medical problems (e.g., unstable seizure disorders)
- For parents, no severe mental health problems (e.g., suicidal intent, psychosis)
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Tech Autism Clinic
Blacksburg, Virginia, 24060
About this study
Official title: 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.
Read the 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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Pivotal Response Treatment
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pivotal Response TreatmentBehavioural
Group-based parent training to teach parents behavioral strategies based on principles of learning to motivate their child.
| Study group | Role | What they receive |
|---|---|---|
| mPRT | Experimental | mindfulness-enhanced Pivotal Response Treatment: group pivotal response training for parents that is supplemented with mindfulness strategies Receives: Behavioral: Pivotal Response Treatment |
| pPRT | Active comparator | psychoeducation-enhanced Pivotal Response Treatment: group pivotal response training for parents that is supplemented with psychoeducation about stress and stress reduction Receives: Behavioral: Pivotal Response Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: weekly, from start of treatment through 12 weeks
Child utterances - observation
level or amount of child utterances during a structured laboratory task observation
Measured: pre-treatment at intake
Child utterances - observation
level or amount of child utterances during a structured laboratory task observation
Measured: mid-treatment, at 6 weeks from start of treatment
Child utterances - observation
level or amount of child utterances during a structured laboratory task observation
Measured: weekly, from start of treatment through 12 weeks
Child utterances - observation
level or amount of child utterances during a structured laboratory task observation
Measured: post-treatment, at 12 weeks from start of treatment
Child utterances - observation
level or amount of child utterances during a structured laboratory task observation
Measured: 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)
Measured: weekly, from start of treatment through 12 weeks
Parenting Stress Index, 4th edition
level of parent-reported stress;
Measured: pre-treatment at intake
Parenting Stress Index, 4th edition
level of parent-reported stress
Measured: mid-treatment, at 6 weeks from start of treatment
Parenting Stress Index, 4th edition
level of parent-reported stress
Measured: post-treatment, at 12 weeks from start of treatment
Parenting Stress Index, 4th edition
level of parent-reported stress
Measured: 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
Measured: pre-treatment at intake
Autism Parenting Stress Index
level of parent-reported stress specific for parents of young autistic children
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: follow-up, at 3 months after last treatment session
Secondary outcomes (16)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: follow-up, at 3 months after last treatment session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2023
- Study start10 Apr 2017
- Primary completion4 Feb 2020
- Study completion4 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Polytechnic Institute and State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angela Scarpa-Friedman, Virginia Polytechnic Institute and State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05948202
- Sponsor's protocol ID
- 17-079
- Status last verified
- Jul 2023
- First submitted
- 1 Jun 2023
- Last updated
- 17 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified data are shared with other members of the research team.
Publications
Hayes SA, Watson SL. The impact of parenting stress: a meta-analysis of studies comparing the experience of parenting stress in parents of children with and without autism spectrum disorder. J Autism Dev Disord. 2013 Mar;43(3):629-42. doi: 10.1007/s10803-012-1604-y.
PubMed 22790429Osborne LA, McHugh L, Saunders J, Reed P. Parenting stress reduces the effectiveness of early teaching interventions for autistic spectrum disorders. J Autism Dev Disord. 2008 Jul;38(6):1092-103. doi: 10.1007/s10803-007-0497-7. Epub 2007 Nov 20.
PubMed 18027079
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Mindfulness-Enhanced Pivotal Response Group Treatment on Parenting Stress: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05948202
- Acronym / sponsor ID
- 17-079
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Virginia Polytechnic Institute and State UniversityUniversity, hospital or other
- Study start
- 10 Apr 2017 (actual)
- Primary completion
- 4 Feb 2020 (actual)
- Study completion
- 4 Feb 2020 (actual)
- First posted
- 17 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| mPRT | Experimental | Behavioral: Pivotal Response Treatmentmindfulness-enhanced Pivotal Response Treatment: group pivotal response training for parents that is supplemented with mindfulness strategies |
| pPRT | Active comparator | Behavioral: Pivotal Response Treatmentpsychoeducation-enhanced Pivotal Response Treatment: group pivotal response training for parents that is supplemented with psychoeducation about stress and stress reduction |
Who may qualify
- Ages
- 18 months to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- For children, no active medical problems (e.g., unstable seizure disorders)
- For parents, no severe mental health problems (e.g., suicidal intent, psychosis)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pivotal Response TreatmentGroup-based parent training to teach parents behavioral strategies based on principles of learning to motivate their child. | Behavioural | mPRT, pPRT |
Primary outcome
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)
Child utterances - observation
Time frame: pre-treatment at intake
level or amount of child utterances during a structured laboratory task observation
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
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
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
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
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)
Parenting Stress Index, 4th edition
Time frame: pre-treatment at intake
level of parent-reported stress;
Parenting Stress Index, 4th edition
Time frame: mid-treatment, at 6 weeks from start of treatment
level of parent-reported stress
Parenting Stress Index, 4th edition
Time frame: post-treatment, at 12 weeks from start of treatment
level of parent-reported stress
Parenting Stress Index, 4th edition
Time frame: follow-up, at 3 months after last treatment session
level of parent-reported stress
Autism Parenting Stress Index
Time frame: pre-treatment at intake
level of parent-reported stress specific for parents of young autistic children
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
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
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
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
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
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
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
16 secondary outcomes
Parent Feelings Questionnaire
Time frame: pre-treatment, at intake
Parent Feelings Questionnaire
Time frame: mid-treatment, at 6 weeks from start of treatment
Parent Feelings Questionnaire
Time frame: post-treatment, at 12 weeks from start of treatment
Parent Feelings Questionnaire
Time frame: follow-up, at 3 months after last treatment session
Positive and Negative Affect Schedule
Time frame: pre-treatment, at intake
Positive and Negative Affect Schedule
Time frame: 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
Positive and Negative Affect Schedule
Time frame: follow-up, at 3 months after last treatment session
Five Facet Mindfulness Questionnaire
Time frame: pre-treatment, at intake
Five Facet Mindfulness Questionnaire
Time frame: mid-treatment, at 6 weeks from start of treatment
Five Facet Mindfulness Questionnaire
Time frame: post-treatment, at 12 weeks from start of treatment
Five Facet Mindfulness Questionnaire
Time frame: follow-up, at 3 months after last treatment session
Acceptance and Action Questionnaire
Time frame: pre-treatment, at intake
Child Behavior Checklist for ages 1.5 to 5
Time frame: 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
Child Behavior Checklist for ages 1.5 to 5
Time frame: follow-up, at 3 months after last treatment session
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2023.
- Background: PubMed 22790429Hayes SA, Watson SL. The impact of parenting stress: a meta-analysis of studies comparing the experience of parenting stress in parents of children with and without autism spectrum disorder. J Autism Dev Disord. 2013 Mar;43(3):629-42. doi: 10.1007/s10803-012-1604-y.
- Background: PubMed 18027079Osborne LA, McHugh L, Saunders J, Reed P. Parenting stress reduces the effectiveness of early teaching interventions for autistic spectrum disorders. J Autism Dev Disord. 2008 Jul;38(6):1092-103. doi: 10.1007/s10803-007-0497-7. Epub 2007 Nov 20.
- Individual participant dataSharing planned: Yes. The de-identified data are shared with other members of the research team.
Related trials for Autism Spectrum Disorder
RecruitingPhase 1
Cannabidiol (CBD) in Adults With ASD
Autism Spectrum Disorder
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Sensory-integration Therapy Verses Augumented Reality-based Training in ASD
Autism Spectrum Disorder
Recruiting
Cumulative and Booster Effects of Multisession Prefrontal tDCS in ASD Adolescents
Transcranial Direct Current Stimulation, Autistic Spectrum Disorder
Not yet recruiting
"Family Resilience And Mind-body Enhancement" (FRAME): A Randomised Controlled Trial
Autism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pivotal Response Treatment in people with Autism Spectrum Disorder, run by Virginia Polytechnic Institute and State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Therapist fidelity observation (time frame: weekly, from start of treatment through 12 weeks). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05948202, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2023.