Ignite Creation Date:
2025-12-25 @ 3:57 AM
Ignite Modification Date:
2025-12-26 @ 2:49 AM
Study NCT ID:
NCT05948202
Status:
COMPLETED
Last Update Posted:
2023-07-17
First Post:
2023-06-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Mindfulness-Enhanced Pivotal Response Group Treatment on Parenting Stress
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}], 'ancestors': [{'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-06-01', 'size': 1064685, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-06-01T10:06', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'randomized controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2020-02-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-07', 'studyFirstSubmitDate': '2023-06-01', 'studyFirstSubmitQcDate': '2023-07-07', 'lastUpdatePostDateStruct': {'date': '2023-07-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Parent Treatment Satisfaction Questionnaire', 'timeFrame': 'post-treatment, at 12 weeks from start of treatment', 'description': '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.'}], 'primaryOutcomes': [{'measure': 'Therapist fidelity observation', 'timeFrame': 'weekly, from start of treatment through 12 weeks', 'description': '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)'}, {'measure': 'Child utterances - observation', 'timeFrame': 'pre-treatment at intake', 'description': 'level or amount of child utterances during a structured laboratory task observation'}, {'measure': 'Child utterances - observation', 'timeFrame': 'mid-treatment, at 6 weeks from start of treatment', 'description': 'level or amount of child utterances during a structured laboratory task observation'}, {'measure': 'Child utterances - observation', 'timeFrame': 'weekly, from start of treatment through 12 weeks', 'description': 'level or amount of child utterances during a structured laboratory task observation'}, {'measure': 'Child utterances - observation', 'timeFrame': 'post-treatment, at 12 weeks from start of treatment', 'description': 'level or amount of child utterances during a structured laboratory task observation'}, {'measure': 'Child utterances - observation', 'timeFrame': 'follow-up, at 3 months after the last treatment session', 'description': 'level or amount of child utterances during a structured laboratory task observation'}, {'measure': 'Parent fidelity observation', 'timeFrame': 'weekly, from start of treatment through 12 weeks', 'description': '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)'}, {'measure': 'Parenting Stress Index, 4th edition', 'timeFrame': 'pre-treatment at intake', 'description': 'level of parent-reported stress;'}, {'measure': 'Parenting Stress Index, 4th edition', 'timeFrame': 'mid-treatment, at 6 weeks from start of treatment', 'description': 'level of parent-reported stress'}, {'measure': 'Parenting Stress Index, 4th edition', 'timeFrame': 'post-treatment, at 12 weeks from start of treatment', 'description': 'level of parent-reported stress'}, {'measure': 'Parenting Stress Index, 4th edition', 'timeFrame': 'follow-up, at 3 months after last treatment session', 'description': 'level of parent-reported stress'}, {'measure': 'Autism Parenting Stress Index', 'timeFrame': 'pre-treatment at intake', 'description': 'level of parent-reported stress specific for parents of young autistic children'}, {'measure': 'Autism Parenting Stress Index', 'timeFrame': 'mid-treatment, at 6 weeks from start of treatment', 'description': 'level of parent-reported stress specific for parents of young autistic children'}, {'measure': 'Autism Parenting Stress Index', 'timeFrame': 'post-treatment, at 12 weeks from start of treatment', 'description': 'level of parent-reported stress specific for parents of young autistic children'}, {'measure': 'Autism Parenting Stress Index', 'timeFrame': 'follow-up, at 3 months after last treatment session', 'description': 'level of parent-reported stress specific for parents of young autistic children'}, {'measure': 'Subjective Units of Parenting Stress Scale', 'timeFrame': 'pre-treatment at intake', 'description': 'level of parent-reported stress immediately following the structured lab observation, with 0 signifying no stress and 100 signifying extreme stress'}, {'measure': 'Subjective Units of Parenting Stress Scale', 'timeFrame': 'mid-treatment, at 6 weeks from start of treatment', 'description': 'level of parent-reported stress immediately following the structured lab observation, with 0 signifying no stress and 100 signifying extreme stress'}, {'measure': 'Subjective Units of Parenting Stress Scale', 'timeFrame': 'post-treatment, at 12 weeks from start of treatment', 'description': 'level of parent-reported stress immediately following the structured lab observation, with 0 signifying no stress and 100 signifying extreme stress'}, {'measure': 'Subjective Units of Parenting Stress Scale', 'timeFrame': 'follow-up, at 3 months after last treatment session', 'description': 'level of parent-reported stress immediately following the structured lab observation'}], 'secondaryOutcomes': [{'measure': 'Parent Feelings Questionnaire', 'timeFrame': 'pre-treatment, at intake', 'description': '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'}, {'measure': 'Parent Feelings Questionnaire', 'timeFrame': 'mid-treatment, at 6 weeks from start of treatment', 'description': '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'}, {'measure': 'Parent Feelings Questionnaire', 'timeFrame': 'post-treatment, at 12 weeks from start of treatment', 'description': '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'}, {'measure': 'Parent Feelings Questionnaire', 'timeFrame': 'follow-up, at 3 months after last treatment session', 'description': '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'}, {'measure': 'Positive and Negative Affect Schedule', 'timeFrame': 'pre-treatment, at intake', 'description': 'parent-reported positive and negative affect in adults; 5 point scale from very slightly to extremely; higher scores mean higher levels of the feeling'}, {'measure': 'Positive and Negative Affect Schedule', 'timeFrame': 'mid-treatment, at 6 weeks from start of treatment', 'description': 'parent-reported positive and negative affect in adults; 5 point scale from very slightly to extremely; higher scores mean higher levels of the feeling'}, {'measure': 'Positive and Negative Affect Schedule', 'timeFrame': 'post-treatment, at 12 weeks from start of treatment', 'description': 'parent-reported positive and negative affect in adults; 5 point scale from very slightly to extremely; higher scores mean higher levels of the feeling'}, {'measure': 'Positive and Negative Affect Schedule', 'timeFrame': 'follow-up, at 3 months after last treatment session', 'description': 'parent-reported positive and negative affect in adults; 5 point scale from very slightly to extremely; higher scores mean higher levels of the feeling'}, {'measure': 'Five Facet Mindfulness Questionnaire', 'timeFrame': 'pre-treatment, at intake', 'description': 'parent-reported propensity toward mindfulness in everyday life; 5 point scale from never true to always true; higher scores mean more mindfulness'}, {'measure': 'Five Facet Mindfulness Questionnaire', 'timeFrame': 'mid-treatment, at 6 weeks from start of treatment', 'description': 'parent-reported propensity toward mindfulness in everyday life; 5 point scale from never true to always true; higher scores mean more mindfulness'}, {'measure': 'Five Facet Mindfulness Questionnaire', 'timeFrame': 'post-treatment, at 12 weeks from start of treatment', 'description': 'parent-reported propensity toward mindfulness in everyday life; 5 point scale from never true to always true; higher scores mean more mindfulness'}, {'measure': 'Five Facet Mindfulness Questionnaire', 'timeFrame': 'follow-up, at 3 months after last treatment session', 'description': 'parent-reported propensity toward mindfulness in everyday life; 5 point scale from never true to always true; higher scores mean more mindfulness'}, {'measure': 'Acceptance and Action Questionnaire', 'timeFrame': 'pre-treatment, at intake', 'description': 'parent-reported level of experiential avoidance, on a 7 point scale from never true to always true; higher scores indicate more avoidance'}, {'measure': 'Child Behavior Checklist for ages 1.5 to 5', 'timeFrame': 'mid-treatment, at 6 weeks from start of treatment', 'description': 'parent-reported measure of child emotional and behavioral concerns; converted to t-scores; higher scores indicate higher levels of the behavior problem'}, {'measure': 'Child Behavior Checklist for ages 1.5 to 5', 'timeFrame': 'post-treatment, at 12 weeks from start of treatment', 'description': 'parent-reported measure of child emotional and behavioral concerns; converted to t-scores; higher scores indicate higher levels of the behavior problem'}, {'measure': 'Child Behavior Checklist for ages 1.5 to 5', 'timeFrame': 'follow-up, at 3 months after last treatment session', 'description': 'parent-reported measure of child emotional and behavioral concerns; converted to t-scores; higher scores indicate higher levels of the behavior problem'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Autism Spectrum Disorder']}, 'referencesModule': {'references': [{'pmid': '22790429', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '18027079', 'type': 'BACKGROUND', 'citation': 'Osborne 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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '18 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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\n* For parents: willingness to attend group treatment sessions, record weekly videos, and share videos in a group setting\n\nExclusion Criteria:\n\n* For children, no active medical problems (e.g., unstable seizure disorders)\n* For parents, no severe mental health problems (e.g., suicidal intent, psychosis)'}, 'identificationModule': {'nctId': 'NCT05948202', 'briefTitle': 'Mindfulness-Enhanced Pivotal Response Group Treatment on Parenting Stress', 'organization': {'class': 'OTHER', 'fullName': 'Virginia Polytechnic Institute and State University'}, 'officialTitle': 'Impact of Mindfulness-Enhanced Pivotal Response Group Treatment on Parenting Stress: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '17-079'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'mPRT', 'description': 'mindfulness-enhanced Pivotal Response Treatment: group pivotal response training for parents that is supplemented with mindfulness strategies', 'interventionNames': ['Behavioral: Pivotal Response Treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'pPRT', 'description': 'psychoeducation-enhanced Pivotal Response Treatment: group pivotal response training for parents that is supplemented with psychoeducation about stress and stress reduction', 'interventionNames': ['Behavioral: Pivotal Response Treatment']}], 'interventions': [{'name': 'Pivotal Response Treatment', 'type': 'BEHAVIORAL', 'description': 'Group-based parent training to teach parents behavioral strategies based on principles of learning to motivate their child.', 'armGroupLabels': ['mPRT', 'pPRT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '24060', 'city': 'Blacksburg', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Tech Autism Clinic', 'geoPoint': {'lat': 37.22957, 'lon': -80.41394}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'ipdSharing': 'YES', 'description': 'The de-identified data are shared with other members of the research team.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Virginia Polytechnic Institute and State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Angela Scarpa-Friedman', 'investigatorAffiliation': 'Virginia Polytechnic Institute and State University'}}}}