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Oppositional Defiant DisorderPFS2NCT03729154

Preschool First Step to Success: An Efficacy Replication Study

A study testing First Step in people with Oppositional Defiant Disorder, run by Oregon Research Institute.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 4 to 5 yearsHealthy volunteers can take part
Conditions the study is for
Oppositional Defiant Disorder
What is being tested?
First Step
Could I receive a placebo?
No, everyone receives an active treatment
How many people
162 participants
Where
No sites listed yet
Study dates
1 Oct 2015to 30 Jun 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 5 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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).

Who cannot join

  • Children with significant psychopathology, such as schizophrenia.

About this study

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.

Read the 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.

Being tested
First Step
Medical subject headings
Oppositional Defiant Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • First StepBehavioural

    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.

Study groups in NCT03729154
Study groupRoleWhat they receive
First StepExperimentalFirst 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.
Receives: Behavioral: First Step
Treatment as UsualNo interventionParticipants in the Treatment as Usual condition will receive behavioral and counseling services typically provided by their preschool.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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,

    Measured: Change from Baseline Social Skill Score at 4 months, 8 months, 12 months and 16 months

  2. 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,

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

  3. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Nov 2018
  2. Study start1 Oct 2015
  3. Primary completion1 Apr 2022
  4. Study completion30 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
162 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03729154
Sponsor's protocol ID
R32 4A150221
Acronym
PFS2
Status last verified
Sep 2023
First submitted
29 Oct 2018
Last updated
26 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing First Step in people with Oppositional Defiant Disorder, run by Oregon Research Institute.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Social Skills Improvement System Rating Scale (time frame: Change from Baseline Social Skill Score at 4 months, 8 months, 12 months and 16 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2023.

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