CompletedNot Applicable

Effectiveness Evaluation of a Comprehensive School Readiness Summer Program for Young Children At-Risk

United States124 participantsStarted 2016-03-16

Plain-language summary

This study is a program evaluation or open-trial study of the effectiveness of Summer Academy, a comprehensive summer early intervention program for young children with early learning and disruptive behavior problems (based on the nationally recognized, evidence-based Children's Summer Treatment Program) living in at-risk community settings. The summer program, which is funded by The Children's Trust, will be held annually from June to August from Summer 2016 - Summer 2019 at an early childhood center located in the Liberty City community of Miami, FL. Our aims are to evaluate how well the program helps to prepare young children for the transition to kindergarten and measure to how well progress is maintained at six-month follow-up.

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

. transitioning to kindergarten the following school year;
. had behavioral, learning, attention, or other social emotional difficulties, as evidenced by meeting diagnostic criteria for a behavioral or emotional disorder (e.g., Attention-Deficit/Hyperactivity Disorder, Oppositional Defiant Disorder) or qualify for special education services via an Individualized Education Program (IEP);
. had the cognitive and language skills needed to appropriately benefit from the program; and
. be able to attend the 7-week intervention program with weekly parent training.

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

Behavioral Functioning

Timeframe: From enrollment until the end of intervention at 7 weeks and then again at six months follow up

Behavioral Symptomatology

Timeframe: From enrollment until the end of intervention at 7 weeks and then again at six months follow up

Behavioral Impairment

Timeframe: From enrollment until the end of intervention at 7 weeks and then again at six months follow up

Pre-academic skills

Timeframe: From enrollment until the end of intervention at 7 weeks and then again at six months follow up

Executive functioning

Timeframe: From enrollment until the end of intervention at 7 weeks and then again at six months follow up

Parenting Practices

Timeframe: From enrollment until the end of intervention at 7 weeks and then again at six months follow up

Parenting Stress

Trial details

NCT IDNCT07445867

SponsorFlorida International University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-09-01

View on ClinicalTrials.gov More Externalizing Behavior 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.

Inclusion criteria

. transitioning to kindergarten the following school year;
. had behavioral, learning, attention, or other social emotional difficulties, as evidenced by meeting diagnostic criteria for a behavioral or emotional disorder (e.g., Attention-Deficit/Hyperactivity Disorder, Oppositional Defiant Disorder) or qualify for special education services via an Individualized Education Program (IEP);
. had the cognitive and language skills needed to appropriately benefit from the program; and
. be able to attend the 7-week intervention program with weekly parent training.

What they're measuring

Behavioral Functioning

Timeframe: From enrollment until the end of intervention at 7 weeks and then again at six months follow up

Behavioral Symptomatology

Timeframe: From enrollment until the end of intervention at 7 weeks and then again at six months follow up

Behavioral Impairment

Timeframe: From enrollment until the end of intervention at 7 weeks and then again at six months follow up

Pre-academic skills

Timeframe: From enrollment until the end of intervention at 7 weeks and then again at six months follow up

Executive functioning

Timeframe: From enrollment until the end of intervention at 7 weeks and then again at six months follow up

Parenting Practices

Timeframe: From enrollment until the end of intervention at 7 weeks and then again at six months follow up

Parenting Stress