Preschool First Step to Success: An Efficacy Replication Study

NCT03729154 | Completed

• 1 other identifier: R32 4A150221
• Study Type: interventional
• Target: 162
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Oppositional Defiant Disorder

Outcome Measures

Primary Outcomes (3)

• 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 from Baseline Social Skill Score at 4 months, 8 months, 12 months and 16 months

• 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 from Baseline Problem Behavior Score at 4 months, 8 months, 12 months and 16 months

• 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.

  Change from Baseline Problem Behavior Score at 4 months, 8 months, 12 months and 16 months

Study Arms (2)

First Step

EXPERIMENTAL

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.

Behavioral: First Step

Treatment as Usual

NO INTERVENTION

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

Interventions

First Step BEHAVIORAL

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.

First Step

Eligibility Criteria

• Age: 4 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• \*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).

You may not qualify if:

• \*Children with significant psychopathology, such as schizophrenia.

Sponsors & Collaborators

• Oregon Research Institute: lead
• University of Louisville: collaborator

MeSH Terms

Conditions

Oppositional Defiant Disorder

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Edward G Feil, Ph.D.

  Oregon Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2018
• First Posted: November 2, 2018
• Study Start: October 1, 2015
• Primary Completion: April 1, 2022
• Study Completion: June 30, 2023
• Last Updated: September 26, 2023

Record last verified: 2023-09