NCT02715414

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,956

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 3, 2016

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 22, 2016

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

March 2, 2020

Status Verified

February 1, 2020

Enrollment Period

3.2 years

First QC Date

March 3, 2016

Last Update Submit

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 COMPARATOR

A 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).

Behavioral: MFG

MFG + Clinic Implementation Team

EXPERIMENTAL

This 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.

Behavioral: Multiple Family Group + Clinic Implementation Team

Standard Care

NO INTERVENTION

Standard 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 + Clinic Implementation Team
MFGBEHAVIORAL

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.

Also known as: Multiple Family Group
Multiple Family Group (MFG)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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.

    BACKGROUND
  • Hamovitch 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: 29736093BACKGROUND
  • 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.

    BACKGROUND
  • 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 Jun 29.

  • Acri 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.

MeSH Terms

Conditions

Mental Disorders

Interventions

Psychotherapy, Group

Intervention Hierarchy (Ancestors)

Socioenvironmental TherapyPsychotherapyBehavioral Disciplines and Activities

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.

Locations