CompletedNot Applicable

Coparenting, Infant Sleep, and Infant Development

United States216 participantsStarted 2018-11-15

Plain-language summary

This 3-arm RCT tests the effects of a sleep-enhanced adaptation (FF+) of a well-known, evidence-based transition-to-parenting coparenting intervention program (Family Foundations; FF). In one arm, families will experience FF as originally formulated; in the second, families will receive an adapted FF (FF+) program that emphasizes coparenting in infant sleep contexts; the third arm will serve as controls. It is hypothesized that (1) Compared to controls, parents in both FF groups will report improved overall coparenting and reduced overall distress, but parents in the FF+ group will show greater improvements in coparenting and individual parenting in infant sleep contexts, better infant and parent sleep, and better child adjustment; (2) early coparenting around infant sleep will be a central mechanism by which both interventions exert their effects.

Who can participate

Age range

1 Month – 65 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: * Two-parent families (married or living with a partner * Families pregnant with their first child, of any race/ethnicity * Parents who can understand and speak English * Parents over the age of 18 * Parents living in independent units Exclusion Criteria: * Single-parent families * Families pregnant with a second born or later born child * Families who cannot speak and understand English * Families in which one parent under the age of 18 * Parents living with families of origin

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

Overall coparenting quality

Timeframe: 12 months post-partum

Quality of coparenting around infant sleep contexts

Timeframe: 1 month post-partum

Quality of infant sleep

Timeframe: 6 months post-partum

Quality of parent sleep

Timeframe: 6 months post-partum

Attachment Q-Set

Timeframe: 12 months post-partum

Attachment Q-Set

Timeframe: 12 months post-partum

Infant-Toddler Social and Emotional Assessment (ITSEA)

Timeframe: 12 months post-partum

Trial details

NCT IDNCT03187561

SponsorPenn State University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05-09

View on ClinicalTrials.gov More Sleep trials

Plain-language summary

Who can participate

Age range

1 Month – 65 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

Overall coparenting quality

Timeframe: 12 months post-partum

Quality of coparenting around infant sleep contexts

Timeframe: 1 month post-partum

Quality of infant sleep

Timeframe: 6 months post-partum

Quality of parent sleep

Timeframe: 6 months post-partum

Attachment Q-Set

Timeframe: 12 months post-partum

Attachment Q-Set

Timeframe: 12 months post-partum

Infant-Toddler Social and Emotional Assessment (ITSEA)

Timeframe: 12 months post-partum