Family Groups for Urban Youth With Disruptive Behavior



Status:Recruiting
Conditions:Psychiatric, Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:June 2015
End Date:December 2019

Use our guide to learn which trials are right for you!

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 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).

The following Specific Aims guide this study: To 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 and integration and; 4) the impact of CITs on clinic and
provider level moderators of MFG implementation and integration. 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).

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" (R01 MH R01072649; PI: McKay), 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.

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:
We found this trial at
1
site
?
mi
from
New York, NY
Click here to add this to my saved trials