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Family Centered Treatment for Behavioral Problems (2018-0568 Trial)

N/A
Waitlist Available
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Must not have
youth with diagnosed developmental delays or other cognitive impairments will be excluded into the randomization process and recruitment into the longitudinal study.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year, 2 years, 3 years, 4 years
Awards & highlights
No Placebo-Only Group

Summary

This trial found that, among youth authorized to a Level II or Level III out-of-home placement, those who received FCT had better family functioning and mental/behavioral health outcomes, and lower probabilities of being subject of a child protective services report, entering (or re-entering) foster care, being arrested, being retained in grade, being chronically absent, dropping out of high school, or receiving an out-of-home placement, as compared to those who received such a placement. FCT was also associated with lower cost of care.

Who is the study for?
This trial is for children and youth in North Carolina who have behavioral or mental health issues and are authorized for out-of-home placement. They must have a caregiver and home environment suitable for Family Centered Treatment (FCT) but can't participate if they have developmental delays, current safety concerns at home, or are already receiving in-home mental health services from an FCT provider.
What is being tested?
The study compares the effectiveness of Family Centered Treatment (FCT) with Level II or III Out-of-Home Placements (OHP). It aims to see if FCT leads to better family functioning, fewer legal issues, less school absenteeism, lower chances of foster care entry, and reduced costs compared to OHP.
What are the potential side effects?
Since this trial involves social interventions rather than medical treatments, 'side effects' may include emotional distress due to therapy sessions. However, there aren't typical drug side effects as it's not a pharmaceutical intervention.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have developmental delays or cognitive impairments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year, 2 years, 3 years, 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year, 2 years, 3 years, 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Caregiver mental health: Total Problems
Family Functioning: General Functioning
Present Value of FCT compared to Out-of-Home Placement
+1 more
Secondary study objectives
Caregiver mental/Behavioral health: Adaptive Functioning Scales: Education
Caregiver mental/Behavioral health: Adaptive Functioning Scales: Family
Caregiver mental/Behavioral health: Adaptive Functioning Scales: Friends
+53 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Treatment: Family Centered TreatmentExperimental Treatment1 Intervention
Family is offered choice of FCT or Level III out-of-home placement
Group II: Control: Level III Out of Home PlacementActive Control1 Intervention
Family is offered Level III out-of-home placement

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,454 Previous Clinical Trials
2,970,954 Total Patients Enrolled

Media Library

Family Centered Treatment Clinical Trial Eligibility Overview. Trial Name: NCT03641664 — N/A
Psychiatric Disorder Research Study Groups: Control: Level III Out of Home Placement, Treatment: Family Centered Treatment
Psychiatric Disorder Clinical Trial 2023: Family Centered Treatment Highlights & Side Effects. Trial Name: NCT03641664 — N/A
Family Centered Treatment 2023 Treatment Timeline for Medical Study. Trial Name: NCT03641664 — N/A
~105 spots leftby Nov 2025
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