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Completed

NCT Number: NCT03187561

Coparenting, Infant Sleep, and Infant Development

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.

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Key information

Age range

1 month–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Douglas Teti

State College, Pennsylvania, 16802, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Infant sleep-adapted coparenting intervention

Behavioral

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.

Primary outcomes

  1. Overall coparenting quality

    Time frame: 12 months post-partum

    Quality of coparenting

  2. Quality of coparenting around infant sleep contexts

    Time frame: 1 month post-partum

    Quality of coparenting regarding decisions parents make about infant sleep

  3. Quality of infant sleep

    Time frame: 6 months post-partum

    Infant sleep quality from actigraphy and infant sleep diaries reported by parents

  4. Quality of parent sleep

    Time frame: 6 months post-partum

    Sleep quality for each parent, from actigraphy and sleep diary information

  5. Attachment Q-Set

    Time frame: 12 months post-partum

    Quality of infant attachment to mother

  6. Attachment Q-Set

    Time frame: 12 months post-partum

    Quality of infant attachment to father

  7. Infant-Toddler Social and Emotional Assessment (ITSEA)

    Time frame: 12 months post-partum

    Behavioral problems and competencies in infants

Secondary outcomes

  1. Maternal depressive symptoms (Beck Depression Inventory)

    Time frame: 12 months post-partum

    Depressive symptoms reported by mothers

  2. Descriptive In-home Survey of Chaos - Observer ReporteD (DISCORD)

    Time frame: 1 month post-partum

    Household chaos, observed, in families

Other outcomes

  1. Paternal depressive symptoms (Beck Depression Inventory)

    Time frame: 12 months post-partum

    Depressive symptoms reported by fathers

Sponsors and collaborators

Lead sponsor

Penn State University

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Acronym: SIESTA-FF

Important dates

Study start
2018
Primary completion
2025
Study completion
2025
First posted
Jun 15, 2017
Registry last updated
May 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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