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

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

    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

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
Strengths and Difficulties Questionnaire (Parent-report measuring child emotional problems, conduct issues, hyperactivity/inattention, peer relationship problems, and pro- social behavior)
Baseline, 4 months, discharge, 6 months post-discharge, and 12 months post-discharge
Change in Behavioral Symptoms
Time Frame: Baseline, 4 months, and discharge
Clinical Global Impressions (Measures clients' symptom severity, global improvement, and therapeutic response)
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
Change in Executive Functioning Skills
Time Frame: Baseline and 4 months
CANTAB computer-based cognitive tasks (Motor Screening Task, Stop Signal Task, Spatial Span, Multitasking Test, Stockings of Cambridge, Intra-Extra Dimensional Set Shift)
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")
Baseline and 4 months
Treatment providers' fidelity to Collaborative Problem Solving (as a moderator)
Time Frame: provider rating made closest in proximity to four-month timepoint
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.

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

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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