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Preschool First Step to Success: An Efficacy Replication Study (PFS2)

Primary Purpose

Oppositional Defiant Disorder

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
First Step
Sponsored by
Oregon Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oppositional Defiant Disorder

Eligibility Criteria

4 Years - 5 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    First Step

    Treatment as Usual

    Arm 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.

    Participants in the Treatment as Usual condition will receive behavioral and counseling services typically provided by their preschool.

    Outcomes

    Primary Outcome Measures

    Change in Social Skills Improvement System Rating Scale
    The Social Skills Improvement System Rating Scale(Gresham & Elliot, 2008) is the second edition of the Social Skills Rating System and provides a measure of peer-to-peer and teacher-related social skills. The Social Skills subscale of the SSiS-RS is a rating scale completed by teachers and parents across the social skill domain on a 4-point scale from 0=Never, 1= Seldom, 2=Often to 3=Almost Always,
    Change in Problem Behavior Scale
    The Problem Behavior Scale from the Social Skills Improvement System Rating Scale (Gresham & Elliot, 2008) is the second edition of the Social Skills Rating System. The Problem Behavior Scale is a rating scales completed by teachers and parents across problem behavior domain on a 4-point scale from 0=Never, 1= Seldom, 2=Often to 3=Almost Always,
    Change in Teacher-Student Conflict
    The Teacher-Student Conflict instrument provides a measure of child-to-teacher relationship. The Teacher-Student is a rating scale completed by teachers regarding their interactions with the participating child, such as "Dealing with this child drains my energy" and "Despite my best efforts, I'm uncomfortable with how this child and I get along" on a 5-point scale from 0=Definitely does not apply, 1=Does not really apply, 2=Neutral, not sure, 3=Applies somewhat to 4=Definitely applies.

    Secondary Outcome Measures

    Full Information

    First Posted
    October 29, 2018
    Last Updated
    September 22, 2023
    Sponsor
    Oregon Research Institute
    Collaborators
    University of Louisville
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03729154
    Brief Title
    Preschool First Step to Success: An Efficacy Replication Study
    Acronym
    PFS2
    Official Title
    Preschool First Step to Success: An Efficacy Replication Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    October 1, 2015 (Actual)
    Primary Completion Date
    April 1, 2022 (Actual)
    Study Completion Date
    June 30, 2023 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Oregon Research Institute
    Collaborators
    University of Louisville

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Oppositional Defiant Disorder

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    162 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    First Step
    Arm Type
    Experimental
    Arm 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.
    Arm Title
    Treatment as Usual
    Arm Type
    No Intervention
    Arm Description
    Participants in the Treatment as Usual condition will receive behavioral and counseling services typically provided by their preschool.
    Intervention Type
    Behavioral
    Intervention Name(s)
    First Step
    Intervention 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.
    Primary Outcome Measure Information:
    Title
    Change in Social Skills Improvement System Rating Scale
    Description
    The Social Skills Improvement System Rating Scale(Gresham & Elliot, 2008) is the second edition of the Social Skills Rating System and provides a measure of peer-to-peer and teacher-related social skills. The Social Skills subscale of the SSiS-RS is a rating scale completed by teachers and parents across the social skill domain on a 4-point scale from 0=Never, 1= Seldom, 2=Often to 3=Almost Always,
    Time Frame
    Change from Baseline Social Skill Score at 4 months, 8 months, 12 months and 16 months
    Title
    Change in Problem Behavior Scale
    Description
    The Problem Behavior Scale from the Social Skills Improvement System Rating Scale (Gresham & Elliot, 2008) is the second edition of the Social Skills Rating System. The Problem Behavior Scale is a rating scales completed by teachers and parents across problem behavior domain on a 4-point scale from 0=Never, 1= Seldom, 2=Often to 3=Almost Always,
    Time Frame
    Change from Baseline Problem Behavior Score at 4 months, 8 months, 12 months and 16 months
    Title
    Change in Teacher-Student Conflict
    Description
    The Teacher-Student Conflict instrument provides a measure of child-to-teacher relationship. The Teacher-Student is a rating scale completed by teachers regarding their interactions with the participating child, such as "Dealing with this child drains my energy" and "Despite my best efforts, I'm uncomfortable with how this child and I get along" on a 5-point scale from 0=Definitely does not apply, 1=Does not really apply, 2=Neutral, not sure, 3=Applies somewhat to 4=Definitely applies.
    Time Frame
    Change from Baseline Problem Behavior Score at 4 months, 8 months, 12 months and 16 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    4 Years
    Maximum Age & Unit of Time
    5 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Edward G Feil, Ph.D.
    Organizational Affiliation
    Oregon Research Institute
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Preschool First Step to Success: An Efficacy Replication Study

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