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

Child Behavior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04121650
• Other study ID #: 2019P002239
• Status: Active, not recruiting
• 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
• 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

Related Conditions & MeSH terms

• Child Behavior
• Executive Dysfunction
• Problem Behavior

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