Testing the 4Rs and 2Ss Multiple Family Group intervention: study protocol for a randomized controlled trial

Abstract

Background: Oppositional defiant disorder (ODD) is a major mental health concern and highly prevalent among children living in poverty-impacted communities. Despite that treatments for ODD are among the most effective, few children living in poverty receive these services due to substantial barriers to access, as well as difficulties in the uptake and sustained adoption of evidence-based practices (EBPs) in community settings. The purpose of this study is to examine implementation processes that impact uptake of an evidence-based practice for childhood ODD, and the impact of a Clinic Implementation Team (CIT)-driven structured adaptation to enhance its fit within the public mental health clinic setting.

Methods/design: This study, a Hybrid Type II effectiveness-implementation research trial, blends clinical effectiveness and implementation research methods to examine the impact of the 4Rs and 2Ss Multiple Family Group (MFG) intervention, family level mediators of child outcomes, clinic/provider-level mediators of implementation, and the impact of CITs on uptake and long-term utilization of this model. All New York City public outpatient mental health clinics have been invited to participate. A sampling procedure that included randomization at the agency level and a sub-study to examine the impact of clinic choice upon outcomes yielded a distribution of clinics across three study conditions. Quantitative data measuring child outcomes, organizational factors and implementation fidelity will be collected from caregivers and providers at baseline, 8, and 16 weeks from baseline, and 6 months from treatment completion. The expected participation is 134 clinics, 268 providers, and 2688 caregiver/child dyads. We will use mediation analysis with a multi-level Structural Equation Modeling (SEM) (MSEM including family level variables, provider variables, and clinic variables), as well as mediation tests to examine study hypotheses.

Discussion: The aim of the study is to generate knowledge about effectiveness and mediating factors in the treatment of ODDs in children in the context of family functioning, and to propose an innovative approach to the adaptation and implementation of new treatment interventions within clinic settings. The proposed CIT adaptation and implementation model has the potential to enhance implementation and sustainability, and ultimately increase the extent to which effective interventions are available and can impact children and families in need of services for serious behavior problems.

Trial registration: ClinicalTrials.gov, ID: NCT02715414 . Registered on 3 March 2016.

Keywords: Child mental health; Family functioning; Implementation and sustainability; Oppositional defiant disorder.

Conflict of interest statement

Ethics approval and consent to participate

This study was approved by New York University’s Institutional Review Board (IRB). The study was also approved by agencies’ own IRBs when applicable (a list of all ethics committees is attached). An explanation of the study procedures and its risks and benefits is provided to all caregivers and providers via an Informed Consent Form. Participants have an opportunity to read and to receive clarification from the research staff on the content of the Informed Consent Form as well as answers to any additional questions or concerns they might have. Participants receive a copy of the Consent Form, which contains the principal investigator’s contact information and the contact information for the IRB that approved the research project (New York University IRB, number 14-10423). Children are required to give verbal assent in order to participate in the group and to have their caregivers answer questions about them. Research personnel explain the study to the children, using age-appropriate language to ensure their understanding. Children are given the option not to participate, and are assured that refusal to participate will not affect the services that they receive.

All letters of approval from IRBs are attached as a separate document. The New York University IRB was used when agencies did not have their own ethics review board. In the circumstance that agencies had their own IRB, additional approval was sought from their agency as well. The protocol was reviewed by the Services Research and Clinical Epidemiology Branch at the National Institute of Mental Health.

Consent for publication

Any results that will be published in academic journals will adhere to New York University’s IRB guidelines.

Competing interests

The authors declare that they have no competing interests.

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Figures

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Analysis of mediation

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Analysis of mechanisms

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