This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Family Groups for Urban Youth With Disruptive Behavior

This study is currently recruiting participants.
See Contacts and Locations
Verified March 2016 by Mary M. McKay, NYU Silver School of Social Work
Sponsor:
Information provided by (Responsible Party):
Mary M. McKay, NYU Silver School of Social Work
ClinicalTrials.gov Identifier:
NCT02715414
First received: March 3, 2016
Last updated: March 21, 2016
Last verified: March 2016
  Purpose

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).


Condition Intervention
Mental Disorders Behavioral: Multiple Family Group + Clinic Implementation Team Behavioral: MFG

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Family Groups for Urban Youth With Disruptive Behavior

Further study details as provided by Mary M. McKay, NYU Silver School of Social Work:

Primary Outcome Measures:
  • Change in Child Behavior and Impairment [ Time Frame: Baseline, treatment mid-point (8 weeks), posttest (16 weeks), and six month followup (post-treatment) ]
    Child behavior and impairment is assessed via the Disruptive Behavior Disorders Rating Scale.


Other Outcome Measures:
  • Change in Family processes (e.g., rules, responsibilities, relationships, respectful communication) [ Time Frame: Three times points: Baseline, treatment mid-point (8 weeks), posttest (16 weeks) ]
    Family processes, as measured by the Family Assessment Measure, are proposed to mediate primary outcomes

  • Change in Parent stress [ Time Frame: Three times points: Baseline, treatment mid-point (8 weeks), posttest (16 weeks) ]
    Parent Stress, as measured by the Parenting Stress Index, are proposed to mediate primary outcomes

  • Change in Clinic readiness and leadership [ Time Frame: Baseline and posttest (16 weeks) ]
    Measured via the Organizational Readiness for Change

  • Change in Clinic Climate [ Time Frame: Baseline and posttest (16 weeks) ]
    Measured via the Community-Oriented Programs Environment Scale

  • Implementation of the intervention [ Time Frame: Three times points: Baseline, treatment mid-point (8 weeks), posttest (16 weeks) ]
    Program Sustainability Assessment Tool

  • Change in Provider Motivation and Preparedness [ Time Frame: Three times points: Baseline, treatment mid-point (8 weeks), posttest (16 weeks) ]
    MACS Process Measure.

  • Change in Child Behavior (assessed by Iowa Conners Rating Scale) [ Time Frame: Four time points: baseline, treatment mid-point (8 weeks), posttest (16 weeks), and six month followup (post-treatment) ]
    Iowa Conners Rating Scale.

  • Change in Functional Impairment: Child (assessed by Impairment Rating Scale) [ Time Frame: Four time points: baseline, treatment mid-point (8 weeks), posttest (16 weeks), and six month followup (post-treatment) ]
    Impairment Rating Scale

  • Fidelity to the intervention [ Time Frame: Three times points: Baseline, treatment mid-point (8 weeks), posttest (16 weeks) ]
    Measured via the MFG Intervention Fidelity Assessment


Estimated Enrollment: 2956
Study Start Date: June 2015
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Multiple Family Group (MFG)
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 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.
Other Name: Multiple Family Group
Experimental: MFG + Clinic Implementation Team
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
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.
No Intervention: Standard Care
Standard Care consists of services including outpatient individual and family therapy, which are offered as part of clinic care.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02715414

Locations
United States, New York
McSilver Institute for Poverty Policy and Research - New York University Silver School of Social Work Recruiting
New York, New York, United States, 10003
Contact: Mary M McKay, PhD    212-998-5978    mary.mckay@nyu.edu   
Contact: Mary Acri, PhD    212-992-6901    Mary.Acri@nyumc.org   
Sub-Investigator: James Jaccard, PsyD         
Sub-Investigator: Kimberly Hoagwood, PhD         
Sub-Investigator: Anil Chacko, PhD         
Principal Investigator: Mary M. McKay, PhD         
Sponsors and Collaborators
NYU Silver School of Social Work
  More Information

Responsible Party: Mary M. McKay, McSilver Professor of Poverty Studies, Director, McSilver Institute for Poverty Policy and Research, NYU Silver School of Social Work
ClinicalTrials.gov Identifier: NCT02715414     History of Changes
Other Study ID Numbers: R01MH106771 ( U.S. NIH Grant/Contract )
Study First Received: March 3, 2016
Last Updated: March 21, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Problem Behavior
Schizophrenia Spectrum and Other Psychotic Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on September 25, 2017