Family Centered Treatment for Behavioral Problems

(2018-0568 Trial)

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

750 Participants Needed

Trial Summary

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 data supports the effectiveness of the Family Centered Treatment for Behavioral Problems?

Research shows that family-centered treatment models can lead to greater stability for children after discharge compared to standard treatments. Additionally, family-centered practices in early intervention programs have been associated with positive family outcomes, suggesting potential benefits for behavioral problems as well. ^{1 2 3 4 5}

Is Family Centered Treatment for Behavioral Problems safe for humans?

There is limited information on the safety of Family Centered Treatment and similar psychosocial treatments, as they are not routinely tested for safety like medical treatments. Some studies suggest that these treatments can have negative effects on family functioning, highlighting the need for more research on their safety. ^{6 7 8 9 10}

How is Family Centered Treatment different from other treatments for behavioral problems?

Family Centered Treatment is unique because it involves the whole family in the therapy process, focusing on improving family relationships and communication skills to address behavioral problems. This approach is different from individual-focused therapies, as it aims to create a supportive family environment that can lead to better long-term outcomes for the patient. ^{1 11 12 13 14}

What is the purpose of this trial?

Does Family Centered Treatment (FCT) result in better youth, family, and cost outcomes, as compared to a Level II or Level III out-of-home placement (OHP)? The investigators test the hypotheses that among children/youth authorized to a Level II or Level III out-of-home placement, relative to youth who receive such a placement, those who receive FCT will have: * Better: family functioning and mental/behavioral health outcomes (youth and caregiver). * Lower probability of: being subject of a child protective services report, entering (or re-entering) foster care, being arrested, being retained in grade, being chronically absent (missing \>15 days), dropping out of high school, or receiving an out-of-home placement. * Lower cost of care.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Outcomes of family-centered residential treatment. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Impacts of early intervention on family outcomes: A multicenter cross-sectional study in Japan. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Construct validity of the Family Outcomes Survey - Revised expanded helpfulness scale. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

The relationship between patient-centered care and outcomes in specialist drug and alcohol treatment: A systematic literature review. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

The effects of family presence and brief family intervention on global outcome for hospitalized schizophrenic patients. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Negative effects on family functioning from psychosocial treatments: a recommendation for expanded safety monitoring. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Development of a Trigger Tool to Identify Adverse Events and Harm in a Neuropsychiatry Setting. [2023]

8. Netherlands 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. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Review: Adverse event monitoring and reporting in studies of pediatric psychosocial interventions: a systematic review. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

The need for expanded monitoring of adverse events in behavioral health clinical trials. [2012]

11. United States pubmed.ncbi.nlm.nih.gov

Family behavior therapy for substance abuse and other associated problems: a review of its intervention components and applicability. [2009]

12. United States pubmed.ncbi.nlm.nih.gov

Family Behavior Therapy for Use in Child Welfare: Results of a Case Study Involving an Abused Woman Formally Diagnosed With Alcohol Dependence, Bipolar Disorder, and Several Anxiety Disorders. [2021]

13. Finland pubmed.ncbi.nlm.nih.gov

[Family-based psychosocial interventions for children with attention deficit hyperactivity disorder (ADHD), oppositional defiant disorder, and conduct disorder]. [2015]

14. Denmark pubmed.ncbi.nlm.nih.gov

Family-focused treatment for caregivers of patients with bipolar disorder. [2022]