Family Groups for Urban Youth With Disruptive Behavior
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|ClinicalTrials.gov Identifier: NCT02715414|
Recruitment Status : Recruiting
First Posted : March 22, 2016
Last Update Posted : April 18, 2018
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).
|Condition or disease||Intervention/treatment||Phase|
|Mental Disorders||Behavioral: Multiple Family Group + Clinic Implementation Team Behavioral: MFG||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2956 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Official Title:||Family Groups for Urban Youth With Disruptive Behavior|
|Study Start Date :||June 2015|
|Estimated Primary Completion Date :||August 2018|
|Estimated Study Completion Date :||December 2019|
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).
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.
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02715414
|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 firstname.lastname@example.org|
|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|