Family Groups for Urban Youth With Disruptive Behavior

Mental Disorders Clinical Trial

Official title:

Family Groups for Urban Youth With Disruptive Behavior

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02715414
• Other study ID #: R01MH106771
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: December 2019

Study information

• Verified date: February 2020
• Source: NYU Silver School of Social Work
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A multiple family group (MFG) is a family-centered, group delivered, evidence-informed, manualized intervention that targets the most common reason for referral to publicly funded clinics: youth oppositional defiant and conduct disorders. This study will employ a mixed methods Type II effectiveness-implementation hybrid research design.In collaboration with the New York State Office of Mental Health (OMH), this longitudinal study will be conducted across the New York City (NYC) OMH licensed child behavioral health clinic system (n=134). The investigators will use mixed methods, and involve 268 providers and 2,688 adult caregivers of youth (7 to 11 years).

The following Specific Aims guide this study: To examine 1) short-term and longitudinal impact of MFGs on urban youth with Oppositional Defiant Disorder (ODD) and Conduct Disorder (CD) (replication); 2) family-level mediators (e.g. parenting, family process) of child outcomes; 3) clinic (readiness to adopt an innovation, leadership support and climate) and provider level moderators (preparedness, motivation and fidelity) of MFG implementation and integration and; 4) the impact of Clinic Implementation Teams (CIT) on clinic and provider level moderators of MFG implementation and integration. In this Randomized Controlled Trial, clinics will be stratified by borough (Manhattan, Queens, Bronx, Brooklyn, Staten Island) and randomly assigned within borough to 3 study conditions: 1) MFG+CITs; 2) MFG (with standard research training and consultation) or; 3) Standard Care. Data will be collected baseline, 8 and 16 weeks and 6 mo. follow-up) in Phase 1 (focus on implementation) and Phase II (integration).

Description:

This study aims to generate knowledge needed to address seemingly intractable urban service delivery challenges: 1) lack of engagement of low-income youth with serious disruptive behavioral disorders and their families; 2) too few clinics offering family-based, evidence-informed services; 3) lack of scalable, empirically supported interventions designed for resource-strapped child settings and; 4) few empirically supported options for public policy makers to support the uptake and integration of service innovations in their systems.

A multiple family group (MFG) is a family-centered, group delivered, evidence-informed, manualized intervention that targets the most common reason for referral to publicly funded clinics: youth oppositional defiant and conduct disorders.5,6 MFGs target family factors which have been consistently implicated in the onset and maintenance of childhood behavioral disorders.7-9 and integrate components of existing evidence-based practices (EBPs). The MFG service delivery model was developed in collaboration with urban parents and service providers to address the serious challenges associated with EBP roll-outs: low rates of family involvement; poor uptake by providers; clinic and provider impediments to maintaining fidelity; and attenuated child outcome effects. These obstacles are pervasively associated with living and providing care within poverty-impacted communities and resource scarce, urban child behavioral health systems.

Findings from a recently completed NIMH-funded R01 trial, "Family Groups for Urban Youth with Disruptive Behavior" reveal that MFGs are associated with significant improvements relative to standard care (SC) in: 1) rates of family engagement and retention (80% completed); 2) short- (16 weeks) and long-term (10 months) improvements in child conduct problems and impairment; and 3) improvements in parenting and family processes. Although promising, this earlier study did not systematically examine specific mechanisms of family-level change hypothesized to influence child behavior.

Further, although the clinic directors (n=13) and MFG providers (n= 62) expressed strong endorsement of MFGs for their urban, resource constrained sites, significant implementation challenges emerged, potentially compromising future fidelity and sustainability. Thus, clinic and provider-level moderators of MFG implementation and integration will be examined in the current study. The proposed study will also examine a specific implementation strategy based on social-organizational theory (PRISM). Specifically, the investigators will experimentally test the impact of local child mental health clinic implementation teams (CITs), consisting of supervisors, service providers and family partners, on the implementation and integration of MFG. CITs will create site-specific plans to enhance multi-level implementation processes (e.g. clinic readiness to adopt an innovation, leadership support, provider preparedness, motivation and fidelity) in order to increase the likelihood of integrating MFGs into urban child behavioral health clinics.

The proposed study, in response to RFA 15-320, Clinical Trials to Test the Effectiveness of Treatment, Preventative, and Services Interventions, will employ a mixed methods Type II effectiveness-implementation hybrid research design. In collaboration with the NYS Office of Mental Health (OMH), this longitudinal study will be conducted across the NYC OMH licensed child behavioral health clinic system (n=134). The investigators will use mixed methods, and involve 268 providers and 2,688 adult caregivers of youth (7 to 11 years).

This study will examine:

1. short-term and longitudinal impact of MFGs on urban youth with ODD and CD (replication);

2. family-level mediators (e.g. parenting, family process) of child outcomes;

3. clinic (readiness to adopt an innovation, leadership support and climate) and provider level moderators (preparedness, motivation and fidelity) of MFG implementation (Phase I) and integration (Phase II);

4. the impact of CITs on clinic and provider level moderators of MFG implementation (Phase I) and integration (Phase II).

In this RCT, clinics will be stratified by borough (Manhattan, Queens, Bronx, Brooklyn, Staten Island) and randomly assigned within borough to 3 study conditions: 1) MFG+CITs; 2) MFG (with standard research training and consultation) or; 3) Standard Care. Data will be collected baseline, 8 and 16 weeks and 6 mo. follow-up) in Phase 1 (focus on implementation) and Phase II (integration).

The investigators team includes the highest level of NYSOMH research and policy leadership. McKay and Hoagwood are the co-Directors of the NYS Clinic Technical Assistance Center, the NIMH-funded Advanced Center on Implementation of Evidence-based Practice for Children in State Systems (IDEAS; P30 MH09032) and the Center for Collaborative Urban Child Mental Health Services Research (CCCR; P20 MH085983). Advanced methodological expertise (Jaccard, Palinkas), policy (Hogan, Bradbury, Goldman), family (Kuppinger) and provider (Cleek, Perri) consultation from IDEAS/CCCR Center advisors positions the study for maximum public health impact. This team is uniquely prepared to build on an existing research and service infrastructure within a state public mental health system to conduct this study. Because of the nationally-focused centers and the partnerships with NYSOMH, the findings from this study are immediately actionable.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2956
• Est. completion date: December 2019
• Est. primary completion date: August 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• provider willing to participate

• an adult caregiver of a child between 7 and 11 years of age with a diagnosis of Oppositional Defiant Disorder or Conduct Disorder

Exclusion criteria:

• None

Related Conditions & MeSH terms

• Mental Disorders
• Problem Behavior

Intervention

Behavioral:
• Multiple Family Group + Clinic Implementation Team
Clinic Implementation Teams (CIT) include providers at the clinic that aim to enhance uptake and implementation of MFG through modifications of MFG (e.g., format, length of sessions), but no modification to content will occur.
• MFG
MFG is a 12-week group involving 6-8 families of children with problem behaviors. MFG aims to reduce family-level factors that are associated with the onset and perpetuation of problem behaviors. Eight of the 12 sessions are devoted to rules, responsibilities, respectful communication and relationships. Four additional sessions target family stress and social support.

Locations

Country	Name	City	State
United States	McSilver Institute for Poverty Policy and Research - New York University Silver School of Social Work	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Silver School of Social Work

Country where clinical trial is conducted

United States, 

References & Publications (4)

Acri MC, Bornheimer LA, Jessell L, Chomancuzuk AH, Adler JG, Gopalan G, McKay MM. The intersection of extreme poverty and familial mental health in the United States. Soc Work Ment Health. 2017;15(6):677-689. doi: 10.1080/15332985.2017.1319893. Epub 2017 — View Citation

Acri, M., Gopalan, G., Chacko, A., & McKay, M. (in press). Engaging families into treatment for child behavior disorders: A synthesis of the literature. In J. Lochman & W. Mathys (Eds.), Wiley Handbook of Disruptive and Impulse-Control Disorders.

Bornheimer, L. A., Acri, M., Parchment, T. ( in press). Attitudes towards and use of Evidence-Based Practice among providers of child mental health services in New York City. Research on Social Work Practice.

Hamovitch, E., Acri, M., & Bornheimer, L.A. (2018). Who is being served by family mental health programs? Demographic shifts in recipients of services across the last decade. Families in Society, 85, 239-244.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Family processes (e.g., rules, responsibilities, relationships, respectful communication)	Family processes, as measured by the Family Assessment Measure, are proposed to mediate primary outcomes	Three times points: Baseline, treatment mid-point (8 weeks), posttest (16 weeks)
Other	Change in Parent stress	Parent Stress, as measured by the Parenting Stress Index, are proposed to mediate primary outcomes	Three times points: Baseline, treatment mid-point (8 weeks), posttest (16 weeks)
Other	Change in Clinic readiness and leadership	Measured via the Organizational Readiness for Change	Baseline and posttest (16 weeks)
Other	Change in Clinic Climate	Measured via the Community-Oriented Programs Environment Scale	Baseline and posttest (16 weeks)
Other	Implementation of the intervention	Program Sustainability Assessment Tool	Three times points: Baseline, treatment mid-point (8 weeks), posttest (16 weeks)
Other	Change in Provider Motivation and Preparedness	MACS Process Measure.	Three times points: Baseline, treatment mid-point (8 weeks), posttest (16 weeks)
Other	Change in Child Behavior (assessed by Iowa Conners Rating Scale)	Iowa Conners Rating Scale.	Four time points: baseline, treatment mid-point (8 weeks), posttest (16 weeks), and six month followup (post-treatment)
Other	Change in Functional Impairment: Child (assessed by Impairment Rating Scale)	Impairment Rating Scale	Four time points: baseline, treatment mid-point (8 weeks), posttest (16 weeks), and six month followup (post-treatment)
Other	Fidelity to the intervention	Measured via the MFG Intervention Fidelity Assessment	Three times points: Baseline, treatment mid-point (8 weeks), posttest (16 weeks)
Primary	Change in Child Behavior and Impairment	Child behavior and impairment is assessed via the Disruptive Behavior Disorders Rating Scale.	Baseline, treatment mid-point (8 weeks), posttest (16 weeks), and six month followup (post-treatment)