CompletedNot Applicable

Efficacy Trial of the Kids in Transition to School (KITS) Program for Children With Developmental Disabilities and Behavioral Problems

United States209 participantsStarted 2008-04

Plain-language summary

This study focuses on children entering kindergarten with co-occurring developmental disabilities and behavior problems, a population especially likely to have low levels of school readiness. Prior research has shown that children with developmental disabilities are at risk for academic difficulties. Behavioral and social problems are likely to interfere with school adjustment. The investigators hypothesize that children who receive the intervention will show better school readiness and school adjustment outcomes.

Who can participate

Age range

4 Years – 6 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: * Received early childhood special education services * Judged to have behavioral problems that would interfere with the transition to kindergarten * Entering kindergarten in the fall of the year in which recruited into the study Exclusion Criteria: * Mono-lingual Spanish speaker * Severe visual, hearing or physical impairment that would prevent the child from completing the assessment tasks or participating in the intervention

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 caregiver involvement from baseline to kindergarten entry

Timeframe: pre-intervention (baseline), pre-kindergarten ( approximately 2 months post-baseline)

Change in early literacy skills from baseline to kindergarten entry

Timeframe: pre-intervention (baseline), pre-kindergarten ( approximately 2 months post-baseline)

Change in social skills from baseline to kindergarten entry

Timeframe: pre-intervention (baseline), pre-kindergarten ( approximately 2 months post-baseline)

Change in regulatory skills from baseline to kindergarten entry

Timeframe: pre-intervention (baseline), pre-kindergarten ( approximately 2 months post-baseline)

Trial details

NCT IDNCT01593189

SponsorOregon Social Learning Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-03

View on ClinicalTrials.gov More School Readiness trials

Plain-language summary

Who can participate

Age range

4 Years – 6 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 caregiver involvement from baseline to kindergarten entry

Timeframe: pre-intervention (baseline), pre-kindergarten ( approximately 2 months post-baseline)

Change in early literacy skills from baseline to kindergarten entry

Timeframe: pre-intervention (baseline), pre-kindergarten ( approximately 2 months post-baseline)

Change in social skills from baseline to kindergarten entry

Timeframe: pre-intervention (baseline), pre-kindergarten ( approximately 2 months post-baseline)

Change in regulatory skills from baseline to kindergarten entry

Timeframe: pre-intervention (baseline), pre-kindergarten ( approximately 2 months post-baseline)