Executive Function and Symptom Reduction in Youth Receiving Home-based Treatment With Collaborative Problem Solving

June 10, 2026 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Massachusetts General Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Youth Villages
Gerstner Philanthropies

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 14, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 7, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 8, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 10, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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