NCT04121650

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 7, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 10, 2019

Completed
4 days until next milestone

Study Start

First participant enrolled

October 14, 2019

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

April 18, 2023

Status Verified

April 1, 2023

Enrollment Period

2.7 years

First QC Date

October 7, 2019

Last Update Submit

April 13, 2023

Conditions

Keywords

Executive FunctioningADHDBehavior ProblemsYouthCPSCollaborative Problem SolvingDisruptive BehaviorParenting

Outcome Measures

Primary Outcomes (4)

  • Change in Behavioral Symptoms

    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

    Clinical Global Impressions (Measures clients' symptom severity, global improvement, and therapeutic response)

    Baseline, 4 months, and discharge

  • Change in Executive Functioning Skills

    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

    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 Outcomes (2)

  • Change in Child-Parent Relationship

    Baseline and 4 months

  • Treatment providers' fidelity to Collaborative Problem Solving (as a moderator)

    provider rating made closest in proximity to four-month timepoint

Interventions

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.

Also known as: CPS

Eligibility Criteria

Age7 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Child BehaviorProblem BehaviorAttention Deficit Disorder with HyperactivityMental Disorders

Condition Hierarchy (Ancestors)

BehaviorBehavioral SymptomsAttention Deficit and Disruptive Behavior DisordersNeurodevelopmental Disorders

Study Officials

  • Alisha R Pollastri, Ph.D.

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Research and Evaluation, Think:Kids

Study Record Dates

First Submitted

October 7, 2019

First Posted

October 10, 2019

Study Start

October 14, 2019

Primary Completion

July 1, 2022

Study Completion

December 1, 2023

Last Updated

April 18, 2023

Record last verified: 2023-04

Locations