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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04121650
Other study ID # 2019P002239
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date October 14, 2019
Est. completion date December 2023

Study information

Verified date April 2023
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 54
Est. completion date December 2023
Est. primary completion date July 1, 2022
Accepts healthy volunteers No
Gender All
Age group 7 Years to 14 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Collaborative Problem Solving
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.

Locations

Country Name City State
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (3)

Lead Sponsor Collaborator
Massachusetts General Hospital Gerstner Philanthropies, Youth Villages

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Change in Behavioral Symptoms Clinical Global Impressions (Measures clients' symptom severity, global improvement, and therapeutic response) Baseline, 4 months, and discharge
Primary 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
Primary 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 Change in Child-Parent Relationship 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
Secondary Treatment providers' fidelity to Collaborative Problem Solving (as a moderator) 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
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