CompletedNot Applicable

Preschool First Step to Success: An Efficacy Replication Study

162 participantsStarted 2015-10-01

Plain-language 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.

Who can participate

Age range

4 Years – 5 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Social Skills Improvement System Rating Scale

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

Change in Problem Behavior Scale

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

Change in Teacher-Student Conflict

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

Trial details

NCT IDNCT03729154

SponsorOregon Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-04-01

View on ClinicalTrials.gov More Oppositional Defiant Disorder trials

Plain-language summary

Who can participate

Age range

4 Years – 5 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in Social Skills Improvement System Rating Scale

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

Change in Problem Behavior Scale

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

Change in Teacher-Student Conflict

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