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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
- Conditions
- Oppositional Defiant Disorder
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
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.
- First posted2 Nov 2018
- Study start1 Oct 2015
- Primary completion1 Apr 2022
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oppositional Defiant DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Oregon Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- University of Louisville
- Responsible party
- Sponsor
- Investigators
- Edward G Feil, Ph.D., Principal investigator, Oregon Research Institute
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
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preschool First Step to Success: An Efficacy Replication Study
- ClinicalTrials.gov ID
- NCT03729154
- Acronym / sponsor ID
- PFS2 / R32 4A150221
- Conditions
- Oppositional Defiant Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Oregon Research InstituteUniversity, hospital or other
- Collaborators
- University of Louisville
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 2 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| First Step | Experimental | Behavioral: First StepFirst 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. |
| Treatment as Usual | No intervention | –Participants in the Treatment as Usual condition will receive behavioral and counseling services typically provided by their preschool. |
Who may qualify
- Ages
- 4 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- Children with significant psychopathology, such as schizophrenia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| First StepFirst 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. | Behavioural | First Step |
Primary outcome
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 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
Time frame: Change from Baseline Problem Behavior Score at 4 months, 8 months, 12 months and 16 months
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
Time frame: Change from Baseline Problem Behavior Score at 4 months, 8 months, 12 months and 16 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward G Feil, Ph.D. principal investigator
Oregon Research Institute
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.