CompletedNot Applicable

Children's Learning Centers Group FNI

United States90 participantsStarted 2019-01-29

Plain-language summary

The purpose of this study is to compare the effects of Family Nurture Intervention in a mother-child group setting with a Standard Children's Learning Center (CLC) Program for preschool-aged children (ages 2-4.5). This approach is based on creating emotional connection and establishing mother-child two-way regulation, which the investigators hypothesize affects early child development. Mothers and children will be engaged by Nurture Specialists in comforting and calming interactions to regulate each other physically-leading to an automatic calming response to contact with each other.

Who can participate

Age range

24 Months – 57 Months

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: * Mother is able to consent in English or Spanish * Mother is 18 years of age or older at the time of consent * Child is between the ages of 2 to 4 years and 9 months at date of enrollment * Child resides with mother Exclusion Criteria: * The child has severe congenital anomalies or chromosomal anomalies including Downs syndrome and Cerebral Palsy * The child has a diagnosis of Autism Spectrum Disorder * The child has severe motor or physical disability * Mother currently presents with psychosis or is currently taking antipsychotic medication * Current maternal drug and/or alcohol abuse * Mother is more than four months pregnant * Mother and/or infant has a medical condition or contagion that precludes intervention components * Mother is unable to commit to study schedule * Mother is currently involved with the Department of Children and Families (DCF)

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 Videotaped Interrupted Welch Lap Test

Timeframe: Baseline, after 8 sessions/weeks and at 6-months post-accrual

Trial details

NCT IDNCT03908268

SponsorColumbia University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-06-11

View on ClinicalTrials.gov More Relation, Mother-Child trials