Preschool First Step to Success: An Efficacy Replication Study

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Brief Title

Preschool First Step to Success: An Efficacy Replication Study

Official Title

Preschool First Step to Success: An Efficacy Replication Study

Brief Summary

      The purpose of this research is to conduct a Goal 3 efficacy study to replicate the positive
      effects of the preschool version of the First Step intervention- Preschool First Step
      (PFS)-in improving social/behavioral and academic outcomes to support learning, and to begin
      to identify the utility of the intervention (i.e., the degree to which it is feasible and
      practical for implementation in authentic school settings). The primary goal is to replicate
      the impressive FS outcomes previously reported. The second goal is to mantle the PFS
      intervention for dissemination at the program-rather than the classroom-level by addressing
      several aspects of implementation and sustainability in preparation for a Goal 4
      (Effectiveness) trial. PFS was developed via a 5-year Head Start University Partnership grant
      from the Administration for Children, Youth, and Families to adapt FS for Head Start
      populations.
    

Detailed Description

      Children with conduct and oppositional defiant disorders require a substantial effort for
      remediation. Longitudinal research indicates that increased antisocial behavior and
      impairments in social competence skills often serve as harbingers of future adjustment
      problems in a number of domains including mental health, employment, and academic
      achievement. It is critical to divert at-risk children from this path as soon as possible in
      their lives and school careers through early, coordinated interventions involving parents and
      caregivers, teachers and peers. Preschool is an ideal setting for accomplishing this task in
      collaboration with families.

      The purpose of this project is to conduct a Goal 3 efficacy study to replicate the positive
      effects of the preschool version of the First Step to Success intervention in improving
      social/behavioral and academic outcomes to support learning, and to begin to identify the
      utility of the intervention (i.e., the degree to which it is feasible and practical for
      implementation in authentic school settings). Ideally, this project will result in an
      intervention option for serving young children with severely challenging behavior across home
      and school settings that meets the What Works Clearinghouse evidence standards. The preschool
      version of First Step is a fully developed, manualized intervention that targets social
      emotional and academic outcomes for young children with severe behavior problems. This
      application outlines a 4-year randomized efficacy trial in which the primary goal is to
      replicate the impressive outcomes previously reported. The second goal is to mantle the First
      Step intervention for dissemination at the program- rather than the classroom-level by
      addressing several aspects of implementation and sustainability in preparation for a Goal 4
      (Effectiveness) trial. Results from a nearly completed NICHD-funded efficacy trial
      (R01HD055334) provide promising evidence that exposure to the intervention reduced
      participating children's problem behaviors and increased children's social skills. Further,
      the available evidence suggests that the preschool version of First Step can be implemented
      with fidelity, and that the intervention procedures are acceptable to coaches, parents, and
      teachers in preschool settings.

      For this application, preschool programs (Head Start) serving a diverse group of low income
      families in rural and urban Oregon and Kentucky have all agreed to participate in this study.
      This Goal 3 efficacy-replication research application strategically prepares for a future
      effectiveness study with (a) efficacy supported by at least two rigorous trials, (b) specific
      intervention enhancements for training and supervision and (c) measurement and design to test
      efficacy at a broader site/building level rather than classroom. Pre, post, follow-up and
      one-year follow-up data will be collected. Measures to be included in this proposed research
      are questionnaire measures completed by parents and/or teachers, direct assessment of the
      child's academic level (school readiness), direct observations of the classroom environment,
      and implementation and process measures of treatment integrity. The study will utilize a
      cluster randomized controlled trial design that nests teachers and classrooms within early
      childhood buildings/sites. Project staff will recruit 48 EC sites/buildings (24 in Kentucky
      and 24 in Oregon) having 192 low-income families with preschoolers that meet inclusion
      criteria and agree to participate in the study and, after completion of screening procedures
      and baseline data collection, will use a matched pair randomization procedure to assign 24 to
      a Preschool First Step intervention condition and 24 to a business-as-usual control
      condition. Investigators will utilize the mixed-model ANCOVA approach when examining
      differences between intervention and control groups on outcomes, process and social validity
      measures. Results from this replication study will provide the fields of general and special
      education with (a) important evidence that First Step is reliably effective in reducing
      problem behaviors and increasing the prosocial behavior repertoire of preschool children and
      (b) an exploratory investigation of contextual factors that are important for implementation
      success.
    


Study Type

Interventional


Primary Outcome

Change in Social Skills Improvement System Rating Scale


Condition

Oppositional Defiant Disorder

Intervention

First Step

Study Arms / Comparison Groups

 First Step
Description:  First Step is a comprehensive early intervention that is delivered by a behavioral coach who works in collaboration with the classroom teacher and parents. First Step addresses moderate to severe behavior problems of young children and includes both classroom and home components. The program takes about three months from start to finish and requires approximately 60 hours of the coach's time for implementation over this three month period.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Behavioral

Estimated Enrollment

162

Start Date

October 1, 2015

Completion Date

June 30, 2022

Primary Completion Date

April 1, 2019

Eligibility Criteria

        Inclusion Criteria:

        *Children at-risk for development of Oppositional Defiant Disorder with high scores
        exceeding normative criteria on the Systematic Screening for Behavior Disorders (Walker,
        Severson, & Feil, 2014).

        Exclusion Criteria:

        *Children with significant psychopathology, such as schizophrenia.
      

Gender

All

Ages

4 Years - 5 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Edward G Feil, Ph.D., , 



Administrative Informations


NCT ID

NCT03729154

Organization ID

R32 4A150221


Responsible Party

Sponsor

Study Sponsor

Oregon Research Institute

Collaborators

 University of Louisville

Study Sponsor

Edward G Feil, Ph.D., Principal Investigator, Oregon Research Institute


Verification Date

July 2021