Coparenting, Infant Sleep, and Infant Development

Sleep Clinical Trial

— SIESTA-FF  

Official title:

Coparenting, Infant Sleep, and Infant Development

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03187561
• Other study ID #: STUDY00006724
• Secondary ID: R01HD088566
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 15, 2018
• Est. completion date: March 31, 2023

Study information

• Verified date: September 2022
• Source: Penn State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 216
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Month to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Marital Relationship
• Parent-Child Relations
• Parenting
• Sleep

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.

Locations

Country	Name	City	State
United States	Douglas Teti	State College	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Penn State University	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Paternal depressive symptoms (Beck Depression Inventory)	Depressive symptoms reported by fathers	12 months post-partum
Primary	Overall coparenting quality	Quality of coparenting	12 months post-partum
Primary	Quality of coparenting around infant sleep contexts	Quality of coparenting regarding decisions parents make about infant sleep	1 month post-partum
Primary	Quality of infant sleep	Infant sleep quality from actigraphy and infant sleep diaries reported by parents	6 months post-partum
Primary	Quality of parent sleep	Sleep quality for each parent, from actigraphy and sleep diary information	6 months post-partum
Primary	Attachment Q-Set	Quality of infant attachment to mother	12 months post-partum
Primary	Attachment Q-Set	Quality of infant attachment to father	12 months post-partum
Primary	Infant-Toddler Social and Emotional Assessment (ITSEA)	Behavioral problems and competencies in infants	12 months post-partum
Secondary	Maternal depressive symptoms (Beck Depression Inventory)	Depressive symptoms reported by mothers	12 months post-partum
Secondary	Descriptive In-home Survey of Chaos - Observer ReporteD (DISCORD)	Household chaos, observed, in families	1 month post-partum