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NCT03187561: SIESTA-FF

Coparenting, Infant Sleep, and Infant Development

Completed NA Last updated 14 May 2025
What this trial tests

NA trial testing Infant sleep-adapted coparenting intervention in Sleep in 216 participants. Completed in 9 May 2025.

Timeline
15 November 2018
Primary endpoint
9 May 2025
9 May 2025

Quick facts

Lead sponsorPenn State University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designfactorial
Maskingdouble
Primary purposeprevention
Enrollment216
Start date15 November 2018
Primary completion9 May 2025
Estimated completion9 May 2025
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Penn State University

Who can join

Adults 1 Month to 65, any sex, with Sleep or Parenting. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other recruiting trials for Sleep

Currently open trials in the same condition.

Other Penn State University trials

Trials by the same sponsor.

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Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing