Coparenting, Infant Sleep, and Infant Development (SIESTA-FF)

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.

Study Overview

• Status: Completed
• Conditions: Sleep; Parent-Child Relations; Parenting; Marital Relationship
• Intervention / Treatment: Behavioral: Infant sleep-adapted coparenting intervention

Detailed Description

Although infant sleep regulation across the first year proceeds well for many infants, for many infants that is not the case, and estimates of sleep problems among infants and preschoolers range between 25%-33%. Dysregulated infant sleep is predictive of poor parent sleep, and chronic sleep disruption can place families in turmoil, with consequences for the marital and coparenting relationship. Further, mothers reporting early coparenting distress are at risk for personal distress and poor bedtime and nighttime parenting, which in turn predicts infant sleep problems and insecure infant attachment. This application proposes a randomized clinical trial (RCT) to evaluate the effects of a sleep-enhanced adaptation of an evidence-based transition-to-parenting coparenting intervention program [Family Foundations - FF). The rationale for this study is twofold. First, recent findings from the PI's Project SIESTA (R01HD052809) indicate that poor coparenting at one month post-partum predicts persistent infant-parent co-sleeping across the first year, elevated maternal depressive symptoms, emotionally unavailable bedtime parenting, and insecure infant-mother attachments. Second, whereas FF as originally developed has been successful in improving coparenting, marital adjustment, and overall parenting quality, it gives little specific attention to coparenting in infant sleep contexts, which SIESTA findings identify as critically important to parent and infant outcomes later in the first year. The proposed 3-arm RCT responds to these concerns. In one arm, families will experience FF as originally formulated; in the second, families will receive an adapted FF that emphasizes coparenting in infant sleep contexts; the third arm will serve as controls. Assessments of coparenting and parenting in infant sleep contexts, parental adjustment to infant sleep behavior, choices about sleep arrangements, infant and parent sleep quality, and infant socio-emotional functioning, will serve as outcomes. Our central hypotheses are: (1) Compared to controls, parents in both FF groups will report improved overall coparenting and reduced overall distress, but parents in the adapted 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. This research is foundational to a broader understanding of coparenting processes that underlie successful family transitions and contributes to the refinement of a successful coparenting program. Study results will be of immediate use to obstetric and pediatric services interested in augmenting childbirth education material with information on coparenting practices in infant sleep contexts.

• Study Type: Interventional
• Enrollment (Actual): 216
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • State College, Pennsylvania, United States, 16802
      • Douglas Teti

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Family Foundations (FF); The original Family Foundations transition-to-parenthood coparenting intervention will be implemented to all participants assigned to this arm	Behavioral: Infant sleep-adapted coparenting intervention; The Family Foundations intervention, as originally formulated, and a sleep-adapted Family Foundations intervention, will be implemented to participants in arm 1 and arm 2, respectively.
Experimental: Sleep-adapted Family Foundations (FF+); A sleep-adapted Family Foundations transition-to-parenthood coparenting intervention will be implemented to all participants in this arm. The adaptation will be an emphasis on coparenting in relation to infant sleep concerns and activities.	Behavioral: Infant sleep-adapted coparenting intervention; The Family Foundations intervention, as originally formulated, and a sleep-adapted Family Foundations intervention, will be implemented to participants in arm 1 and arm 2, respectively.
Other: Control; Participants in this arm will not receive either intervention.	Behavioral: Infant sleep-adapted coparenting intervention; The Family Foundations intervention, as originally formulated, and a sleep-adapted Family Foundations intervention, will be implemented to participants in arm 1 and arm 2, respectively.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall coparenting quality	Quality of coparenting	12 months post-partum
Quality of coparenting around infant sleep contexts	Quality of coparenting regarding decisions parents make about infant sleep	1 month post-partum
Quality of infant sleep	Infant sleep quality from actigraphy and infant sleep diaries reported by parents	6 months post-partum
Quality of parent sleep	Sleep quality for each parent, from actigraphy and sleep diary information	6 months post-partum
Attachment Q-Set	Quality of infant attachment to mother	12 months post-partum
Attachment Q-Set	Quality of infant attachment to father	12 months post-partum
Infant-Toddler Social and Emotional Assessment (ITSEA)	Behavioral problems and competencies in infants	12 months post-partum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal depressive symptoms (Beck Depression Inventory)	Depressive symptoms reported by mothers	12 months post-partum
Descriptive In-home Survey of Chaos - Observer ReporteD (DISCORD)	Household chaos, observed, in families	1 month post-partum

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Paternal depressive symptoms (Beck Depression Inventory)	Depressive symptoms reported by fathers	12 months post-partum

Collaborators and Investigators

• Sponsor: Penn State University
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2018
• Primary Completion (Actual): May 9, 2025
• Study Completion (Actual): May 9, 2025

Study Registration Dates

• First Submitted: June 9, 2017
• First Submitted That Met QC Criteria: June 12, 2017
• First Posted (Actual): June 15, 2017

Study Record Updates

• Last Update Posted (Actual): May 14, 2025
• Last Update Submitted That Met QC Criteria: May 9, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Sleep; Parenting; Marital relationship; Parent-child relations
• Other Study ID Numbers: STUDY00006724; R01HD088566 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No