Clinical trial NCT03187561: Coparenting, Infant Sleep, and Infant Development
Official title: Coparenting, Infant Sleep, and Infant Development
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Parenting
Marital Relationship
Parent-Child Relations
Keywords: Sleep
Parenting
Marital relationship
Parent-child relations
Lead sponsor: Penn State University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2017-06-15
Enrollment: 216
Sex: ALL
Minimum age (years): 1
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: In the proposed 3-arm RCT, in one arm families will experience Family Foundations (FF) intervention 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.
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall coparenting quality
timeFrame: 12 months post-partum
measure: Quality of coparenting around infant sleep contexts
timeFrame: 1 month post-partum
measure: Quality of infant sleep
timeFrame: 6 months post-partum
measure: Quality of parent sleep
timeFrame: 6 months post-partum
measure: Attachment Q-Set
timeFrame: 12 months post-partum
measure: Attachment Q-Set
timeFrame: 12 months post-partum
measure: Infant-Toddler Social and Emotional Assessment (ITSEA)
timeFrame: 12 months post-partum
Secondary outcomes:
measure: Maternal depressive symptoms (Beck Depression Inventory)
timeFrame: 12 months post-partum
measure: Descriptive In-home Survey of Chaos - Observer ReporteD (DISCORD)
timeFrame: 1 month post-partum
Other outcomes:
measure: Paternal depressive symptoms (Beck Depression Inventory)
timeFrame: 12 months post-partum
Locations:
city: State College
country: United States
facility: Douglas Teti
state: Pennsylvania
Study officials:
References: