Family Centered Treatment for Behavioral Problems

(2018-0568 Trial)

Not currently recruiting at 1 trial location

Overseen By Elizabeth J Gifford, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Developmental delays, Cognitive impairments, Safety concerns, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if Family Centered Treatment (FCT) can enhance family dynamics and mental health outcomes more effectively than traditional out-of-home placements for youth with behavioral issues. It also examines whether FCT can reduce negative outcomes, such as school problems or legal issues, and lower care costs. Eligible participants are youth in North Carolina approved for out-of-home placement, with a caregiver and home environment suitable for FCT. As an unphased trial, this study provides participants the chance to contribute to innovative research that could transform family-based interventions.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that Family Centered Treatment is safe for youth and families?

Research has shown that Family Centered Treatment (FCT) is generally safe and well-received by participants. Several studies have examined its effects on families, and none have identified major safety issues. For instance, one study found that participants in family therapy, such as FCT, were more engaged and completed their treatment without negative effects. Another study noted improvements in family functioning and the behavior of young people, indicating that the treatment is beneficial and not harmful.

FCT is a proven approach that focuses on therapy at home to enhance family relationships and mental health. It is based on trauma-informed care, designed to be aware of past traumas and reduce any possible distress. Overall, current research suggests that FCT is a safe choice for families seeking help with behavioral and mental health issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Family Centered Treatment (FCT) for behavioral problems because it offers a unique approach that involves the entire family, rather than just focusing on the individual with the behavioral issues. Unlike traditional treatments that may lead to out-of-home placements, FCT allows families to choose between staying together and receiving therapy or opting for a more institutionalized option. This method emphasizes holistic family involvement, which can lead to more sustainable, long-term improvements in behavior. By addressing the dynamics within the family unit, FCT has the potential to create a more supportive environment for change.

What evidence suggests that Family Centered Treatment is effective for behavioral problems?

Research has shown that Family Centered Treatment (FCT), which participants in this trial may receive, can enhance family functioning and improve mental health for both young people and their caregivers. Studies have found that FCT leads to better outcomes than usual care, such as fewer behavior problems and improved family relationships. One study found that FCT was more effective than placing youth in group homes, as it reduced negative outcomes like arrests and returning to foster care. Additionally, families who participated in FCT experienced fewer disruptions and adjusted better overall. This trial will compare FCT with Level III Out of Home Placement, which serves as the control arm. FCT is a promising method for addressing behavioral issues in teens by involving and supporting the whole family. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am a youth with a supportive caregiver and a stable home.

Participant has been authorized for a level II or level III Out of Home Placement by North Carolina (NC) Division of Medical Assistance

Youth must live within a county in NC where FCT service providers implement FCT.

Exclusion Criteria

I do not have developmental delays or cognitive impairments.

if a youth is currently working with an in-home mental health service provider when the authorization for a Level II or Level III OHP is submitted, that provider cannot be a FCT provider for inclusion into the study

Youth for whom the MCO knows that there are current safety concerns which makes them unable to remain in the home with their parent/guardian

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Family Centered Treatment (FCT) or Level III out-of-home placement

6 months

Regular visits as per treatment protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

18 months

Assessments at 6, 12, and 18 months

Long-term Follow-up

Participants are assessed for long-term outcomes such as educational and legal involvement

4 years

What Are the Treatments Tested in This Trial?

Interventions

• Family Centered Treatment
• Level II or Level III Out of Home Placement

Trial Overview 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.

How Is the Trial Designed?

Group I: Treatment: Family Centered Treatment Experimental Treatment 1 Intervention

Family is offered choice of FCT or Level III out-of-home placement

Group II: Control: Level III Out of Home Placement Active Control 1 Intervention

Family is offered Level III out-of-home placement

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Published Research Related to This Trial

In a systematic review of 117 studies on psychosocial interventions for childhood mental disorders, only 31% monitored adverse events, highlighting a significant gap in safety reporting.

Among the studies that did monitor adverse events, there was a lack of consistency in how these events were defined and assessed, with only 11% evaluating the causes of the events, which is crucial for understanding the risks associated with these treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review: Adverse event monitoring and reporting in studies of pediatric psychosocial interventions: a systematic review. Lodewyk, K., Bagnell, A., Courtney, DB., et al.[2023]

Current clinical trials for behavioral health interventions often do not monitor adverse events as thoroughly as those for medications and medical devices, focusing mainly on serious incidents like suicide attempts and hospitalizations.

There is a need for expanded monitoring of adverse events in psychotherapy trials to better inform patients about potential risks, including temporary increases in anxiety, which are often overlooked but can impact treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The need for expanded monitoring of adverse events in behavioral health clinical trials. Peterson, AL., Roache, JD., Raj, J., et al.[2012]

In a study of 1324 discharged patients, 10.88% experienced adverse events (AEs), with medication-related AEs occurring in 90% of those affected, highlighting the significant risk of harm from neuropsychiatric treatments.

The neuropsychiatry trigger tool (NPTT) was highly effective, identifying 30 times more AEs than traditional reporting methods, suggesting it could be a valuable tool for improving patient safety and reducing harm in hospital settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Trigger Tool to Identify Adverse Events and Harm in a Neuropsychiatry Setting. Sharma, S., Kapoor, K., Nasare, N., et al.[2023]

This study will analyze adverse events in psychotherapy for youth with OCD by including at least 128 participants aged 8-17, comparing family-based cognitive behavioral therapy (FCBT) and family-based psychoeducation and relaxation training (FPRT).

The mixed methods approach will combine quantitative assessments of adverse events with qualitative interviews to better understand their nature and causes, aiming to improve the safety and effectiveness of psychotherapy for OCD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in cognitive behavioral therapy and relaxation training for children and adolescents with obsessive-compulsive disorder: A mixed methods study and analysis plan for the TECTO trial. Pretzmann, L., Christensen, SH., Bryde Christensen, A., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6461369/

Family Therapy Techniques and One-Year Clinical ... This study tested whether use of family therapy (FT) techniques predicted long-term clinical outcomes in usual care for adolescents.

2. familycenteredtreatment.org familycenteredtreatment.org/publications-reports

Publications, Studies & Reports The assessment and outcomes of this paper determined the effectiveness of the Family Centered Treatment (FCT) model of providing care in child protective ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5364075/

Benchmarking Family Therapy for Adolescent Behavior ... This study evaluated whether community therapists delivering family therapy for adolescent behavior problems in usual care achieved performance benchmarks.

4. dhhs.ne.gov dhhs.ne.gov/FFPSA%20Nebraska%20Documents/Sullivan%20Bennear%20Family%20Centered%20Treatment%20Study,%20Revised%20August%202021.pdf

A Quasi-experimental Evaluation of Family Centered ... This created a natural experiment to examine the effectiveness of FCT relative to treatment as usual in group homes. This study uses a quasi-experimental design ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/1467-6427.12476

Family therapy and systemic interventions for child ... After treatment, families who received multisystemic therapy showed greater improvements in parenting, individual adjustment and family ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10160927/

The Impact of Family Therapy Participation on Youths and ... Results. Patients with family therapy had significantly better engagement and treatment completion outcomes than clients with no family therapy.

7. ncsacw.acf.gov ncsacw.acf.gov/files/fca-practice-module-1.pdf

Module 1: Overview of a Family-Centered Approach and Its ... ▫ Improved child developmental and behavioral outcomes. Family-Centered Treatment Encourages Retention in. Treatment – Studies of residential treatment ...

8. nctsn.org nctsn.org/sites/default/files/interventions/family-centered-treatment-2024.pdf

Family Centered Treatment (FCT)©: AT-A-GLANCE FCT is an evidence-based trauma treatment model of home-based family therapy focusing on holistic, family derived goals related to family functioning ...