Resilient, Engaged, and Connected Study (NCT06197997) | Clinical Trial Compass
RecruitingNot Applicable
Resilient, Engaged, and Connected Study
United States840 participantsStarted 2024-09-01
Plain-language summary
Purpose of this study is to test the effectiveness and implementation of an evidence-based parenting intervention for improving parenting and school outcomes in a sample of 4-5-year-old children enrolled in public prekindergarten (PreK) programs in Maryland.
Who can participate
Age range
18 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:
Public school or Community School in Baltimore City, Cecil County, or Harford County serving at least 40% of students meeting eligibility for low-income or located in a community designated as high need by the Maryland State Department of Education based on a score of 0.6 on the Center for Disease Control Social Vulnerability Index:
* has at least 1 full-day public PreK classroom with 20+ students;
* school has not offered CPP in the prior 3 years;
* principal consents to being randomized and participate for 2 years;
* principal consents to study team recruiting parents, teachers, and staff to participate in the study.
PreK Parents:
* Parent (biological, step, adoptive, foster), grandparent, or legal guardian of 4-5 year old student enrolled in participating PreK program;
* 18+ yrs;
* speaks English or Spanish;
* consents to allowing access child's school identification.
Teachers:
* PreK or K teacher in classroom of student of participating parent;
* consents to completing study surveys.
CPP Group Leaders:
* completes CPP group leader training
* agrees to lead CPP groups
* speaks English or Spanish
* at least a High School diploma/General Equivalency Diploma (GED)
* consents to completing surveys and submitting audio recorded CPP sessions for fidelity assessment
School-based personnel inclusion criteria:
* Principal, teacher, or other school-based staff involved in CPP implementation
* consents to interview on perspectives about CPP in the school…
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
1
Social-behavioral readiness as assessed by the social-behavioral domain of the Kindergarten Readiness Assessment (KRA).
Timeframe: 1-year follow-up
2
Percentage of children who reported chronic absence
Timeframe: 1 year
3
Percentage of children who retained in grade
Timeframe: 1 year
4
Social Competence and Behavior Evaluation (SCBE-30) score (Teacher Version)
Timeframe: Baseline, post-intervention up to 4 months, post-intervention up to 8 months, 1-year follow-up
5
Social Competence and Behavior Evaluation (SCBE-30) score (Parent Version)
Timeframe: Baseline, post-intervention up to 4 months, post-intervention up to 8 months, 1-year follow-up
6
Eyberg Child Behavior Inventory (ECBI) score
Timeframe: Baseline, post-intervention up to 4 months, post-intervention up to 8 months, 1-year follow-up
7
Parent engagement as assessed by the Parent-Teacher Involvement Questionnaire