Family Groups for Urban Youth With Disruptive Behavior
1 other identifier
interventional
2,956
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
March 3, 2016
CompletedFirst Posted
Study publicly available on registry
March 22, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedMarch 2, 2020
February 1, 2020
3.2 years
March 3, 2016
February 27, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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)
Other Outcomes (9)
Change in Family processes (e.g., rules, responsibilities, relationships, respectful communication)
Three times points: Baseline, treatment mid-point (8 weeks), posttest (16 weeks)
Change in Parent stress
Three times points: Baseline, treatment mid-point (8 weeks), posttest (16 weeks)
Change in Clinic readiness and leadership
Baseline and posttest (16 weeks)
- +6 more other outcomes
Study Arms (3)
Multiple Family Group (MFG)
ACTIVE COMPARATORA multiple family group (MFG) is a 12-week, family-centered, group delivered intervention consists of six to eight families (caregiver/child dyads). Groups meet for approximately two hours per week, and sessions focus on targeting family-level factors that are associated with child problem behaviors. Specifically, eight of the 12 sessions are devoted to establishing rules (family organization, consistent discipline), responsibilities (inter-connectedness, expectancies), relationships (family warmth, within family support), respectful communication (family communication and conflict). An additional four sessions are focused on factors that impact the ability of families to incorporate new behaviors (family stress and social support).
MFG + Clinic Implementation Team
EXPERIMENTALThis condition consists of service providers, directors, and clinic staff who will create site-specific plans to enhance uptake and implementation of MFG. CITs address potential barriers to implementation and adjust the format and structure of MFG as needed in order to be implemented as part of clinic care.
Standard Care
NO INTERVENTIONStandard Care consists of services including outpatient individual and family therapy, which are offered as part of clinic care.
Interventions
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 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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
McSilver Institute for Poverty Policy and Research - New York University Silver School of Social Work
New York, New York, 10003, United States
Related Publications (5)
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.
BACKGROUNDHamovitch E, Acri M, Bornheimer LA. Who is accessing family mental health programs? Demographic differences before and after system reform. Child Youth Serv Rev. 2018 Jan;85:239-244. doi: 10.1016/j.childyouth.2017.12.027. Epub 2017 Dec 24.
PMID: 29736093BACKGROUNDBornheimer, 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.
BACKGROUNDAcri 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 Jun 29.
PMID: 29618956RESULTAcri M, Hamovitch E, Mini M, Garay E, Connolly C, McKay M. Testing the 4Rs and 2Ss Multiple Family Group intervention: study protocol for a randomized controlled trial. Trials. 2017 Dec 4;18(1):588. doi: 10.1186/s13063-017-2331-7.
PMID: 29202867DERIVED
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- McSilver Professor of Poverty Studies, Director, McSilver Institute for Poverty Policy and Research
Study Record Dates
First Submitted
March 3, 2016
First Posted
March 22, 2016
Study Start
June 1, 2015
Primary Completion
August 1, 2018
Study Completion
December 1, 2019
Last Updated
March 2, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will share
All data collected in this project will be made available to the scientific community for educational, research, and non-profit purposes, and will meet the standards established by NIH and rigorous human subjects protection. Investigators in this proposal will adhere to NIH policy on data sharing as described in http://grants2.nih.gov/grants/policy/data\_sharing/data\_sharing\_guidance.htm. Data request forms and procedures and policies for data sharing have been developed following these guidelines.