Last reviewed · How we verify
NCT03187561: SIESTA-FF
Coparenting, Infant Sleep, and Infant Development
NA trial testing Infant sleep-adapted coparenting intervention in Sleep in 216 participants. Completed in 9 May 2025.
9 May 2025
Quick facts
| Lead sponsor | Penn State University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | factorial |
| Masking | double |
| Primary purpose | prevention |
| Enrollment | 216 |
| Start date | 15 November 2018 |
| Primary completion | 9 May 2025 |
| Estimated completion | 9 May 2025 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Infant sleep-adapted coparenting intervention
Conditions studied
- Sleep — all drugs for Sleep →
- Parenting — all drugs for Parenting →
- Marital Relationship — all drugs for Marital Relationship →
- Parent-Child Relations — all drugs for Parent-Child Relations →
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.
Verify or expand the search:
- PubMed search for NCT03187561
- Europe PMC full search
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Other Penn State University trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03187561 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Penn State University
- Last refreshed: 14 May 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03187561.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing