- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04121650
Executive Function and Symptom Reduction in Youth Receiving Home-based Treatment With Collaborative Problem Solving
April 13, 2023 updated by: Alisha R Pollastri, Massachusetts General Hospital
Executive Functions and Symptom Reduction in Youth Receiving Home-based Treatment With Collaborative Problem Solving
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
54
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
7 years to 14 years (Child)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
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.
Description
Inclusion Criteria:
- Clients of participating non-profit organization that are receiving home-based youth mental health care
- Speaking and writing English at level necessary to complete study requirements
Exclusion Criteria:
- Youth is in full state custody and consent cannot be obtained by a guardian
- Youth and/or guardians do not speak English well enough to complete standardized measures
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Behavioral Symptoms
Time Frame: Baseline, 4 months, discharge, 6 months post-discharge, and 12 months post-discharge
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Strengths and Difficulties Questionnaire (Parent-report measuring child emotional problems, conduct issues, hyperactivity/inattention, peer relationship problems, and pro- social behavior)
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Baseline, 4 months, discharge, 6 months post-discharge, and 12 months post-discharge
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Change in Behavioral Symptoms
Time Frame: Baseline, 4 months, and discharge
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Clinical Global Impressions (Measures clients' symptom severity, global improvement, and therapeutic response)
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Baseline, 4 months, and discharge
|
|
Change in Executive Functioning Skills
Time Frame: Baseline and 4 months
|
Behavior Rating Inventory of Executive Functioning (Parent-report measuring deficits in different domains of executive functioning)
|
Baseline and 4 months
|
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Change in Executive Functioning Skills
Time Frame: Baseline and 4 months
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CANTAB computer-based cognitive tasks (Motor Screening Task, Stop Signal Task, Spatial Span, Multitasking Test, Stockings of Cambridge, Intra-Extra Dimensional Set Shift)
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Baseline and 4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Child-Parent Relationship
Time Frame: Baseline and 4 months
|
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")
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Baseline and 4 months
|
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Treatment providers' fidelity to Collaborative Problem Solving (as a moderator)
Time Frame: provider rating made closest in proximity to four-month timepoint
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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)
|
provider rating made closest in proximity to four-month timepoint
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Alisha R Pollastri, Ph.D., Massachusetts General Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 14, 2019
Primary Completion (Actual)
July 1, 2022
Study Completion (Anticipated)
December 1, 2023
Study Registration Dates
First Submitted
October 7, 2019
First Submitted That Met QC Criteria
October 8, 2019
First Posted (Actual)
October 10, 2019
Study Record Updates
Last Update Posted (Actual)
April 18, 2023
Last Update Submitted That Met QC Criteria
April 13, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019P002239
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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