Ignite Creation Date:
2025-12-24 @ 4:58 PM
Ignite Modification Date:
2025-12-24 @ 4:58 PM
Study NCT ID:
NCT04121650
Status:
UNKNOWN
Last Update Posted:
2023-04-18
First Post:
2019-10-07
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Executive Function and Symptom Reduction in Youth Receiving Home-based Treatment With Collaborative Problem Solving
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002652', 'term': 'Child Behavior'}, {'id': 'D000066553', 'term': 'Problem Behavior'}, {'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}, {'id': 'D001523', 'term': 'Mental Disorders'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-10-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-13', 'studyFirstSubmitDate': '2019-10-07', 'studyFirstSubmitQcDate': '2019-10-08', 'lastUpdatePostDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Behavioral Symptoms', 'timeFrame': 'Baseline, 4 months, discharge, 6 months post-discharge, and 12 months post-discharge', 'description': 'Strengths and Difficulties Questionnaire (Parent-report measuring child emotional problems, conduct issues, hyperactivity/inattention, peer relationship problems, and pro- social behavior)'}, {'measure': 'Change in Behavioral Symptoms', 'timeFrame': 'Baseline, 4 months, and discharge', 'description': "Clinical Global Impressions (Measures clients' symptom severity, global improvement, and therapeutic response)"}, {'measure': 'Change in Executive Functioning Skills', 'timeFrame': 'Baseline and 4 months', 'description': 'Behavior Rating Inventory of Executive Functioning (Parent-report measuring deficits in different domains of executive functioning)'}, {'measure': 'Change in Executive Functioning Skills', 'timeFrame': 'Baseline and 4 months', 'description': 'CANTAB computer-based cognitive tasks (Motor Screening Task, Stop Signal Task, Spatial Span, Multitasking Test, Stockings of Cambridge, Intra-Extra Dimensional Set Shift)'}], 'secondaryOutcomes': [{'measure': 'Change in Child-Parent Relationship', 'timeFrame': 'Baseline and 4 months', 'description': 'Child-Parent Relationship Scale (A 15-question measure of parents perceptions of their relationship with their child by using a scale of 1-5 where 1 "definitely does not apply" and a 5 "definitely applies to the child-parent relationship")'}, {'measure': "Treatment providers' fidelity to Collaborative Problem Solving (as a moderator)", 'timeFrame': 'provider rating made closest in proximity to four-month timepoint', 'description': "CPS Treatment Integrity Rating Form Short (Observational ratings by trained CPS coaches that quantitatively measure providers' fidelity to the practice of the CPS treatment approach)"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Executive Functioning', 'ADHD', 'Behavior Problems', 'Youth', 'CPS', 'Collaborative Problem Solving', 'Disruptive Behavior', 'Parenting'], 'conditions': ['Child Behavior', 'Problem Behavior', 'Executive Dysfunction']}, 'descriptionModule': {'briefSummary': 'In this project, the investigators will extend prior results of parent-reported executive function growth and symptom reduction in children receiving home-based treatment with the Collaborative Problem Solving treatment approach (CPS), with a particular focus on examining children who have attention deficit hyperactivity disorder (ADHD). The investigators will examine executive functioning (EF) of children who are receiving CPS, measuring EF with parent-report and objective computer-based tasks, at two timepoints: at the start of treatment and approximately four months later, and will collect symptoms at these plus three additional timepoints: at discharge, 6-months after discharge, and 12-months after discharge.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '7 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The participants of this study are youth (ages 7 to 14) who are the identified clients being seen in home-based therapy at identified Youth Villages sites in Massachusetts.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clients of participating non-profit organization that are receiving home-based youth mental health care\n* Speaking and writing English at level necessary to complete study requirements\n\nExclusion Criteria:\n\n* Youth is in full state custody and consent cannot be obtained by a guardian\n* Youth and/or guardians do not speak English well enough to complete standardized measures\n* Youth has a confirmed or suspected Full Scale IQ below 70, or carries a prior diagnosis of Autism Spectrum Disorder at the moderate or severe level'}, 'identificationModule': {'nctId': 'NCT04121650', 'briefTitle': 'Executive Function and Symptom Reduction in Youth Receiving Home-based Treatment With Collaborative Problem Solving', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Executive Functions and Symptom Reduction in Youth Receiving Home-based Treatment With Collaborative Problem Solving', 'orgStudyIdInfo': {'id': '2019P002239'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Collaborative Problem Solving', 'type': 'BEHAVIORAL', 'otherNames': ['CPS'], 'description': "CPS is an approach for understanding and reducing challenging behavior in youth. Under CPS, caregivers are taught to understand and identify the specific neurocognitive skill deficits that underlie their child's challenging behavior. Then the caregivers are taught to interact with the child in a way that solves chronic behavior problems while building the lagging neurocognitive skills to avoid future problems."}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Alisha R Pollastri, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Gerstner Philanthropies', 'class': 'UNKNOWN'}, {'name': 'Youth Villages', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Research and Evaluation, Think:Kids', 'investigatorFullName': 'Alisha R Pollastri', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}