Coparenting, Infant Sleep, and Infant Development

NCT03187561 | Completed DMC

• 2 other identifiers: STUDY00006724R01HD088566
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep; Parenting; Marital Relationship; Parent-Child Relations

Keywords

Sleep; Parenting; Marital relationship; Parent-child relations

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (2)

• Maternal depressive symptoms (Beck Depression Inventory)

  12 months post-partum

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

  1 month post-partum

Other Outcomes (1)

• Paternal depressive symptoms (Beck Depression Inventory)

  12 months post-partum

Study Arms (3)

Family Foundations (FF)

EXPERIMENTAL

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

Sleep-adapted Family Foundations (FF+)

EXPERIMENTAL

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

Control

OTHER

Participants in this arm will not receive either intervention.

Behavioral: Infant sleep-adapted coparenting intervention

Interventions

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.

Control; Family Foundations (FF); Sleep-adapted Family Foundations (FF+)

Eligibility Criteria

• Age: 1 Month - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Douglas Teti

State College, Pennsylvania, 16802, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: All participants will be informed that they are being recruited into an intervention study targeting coparenting, but participants will not be informed about which arm of the study to which they have been assigned. Data collectors and outcome assessors will not be informed about which arm of the study to which participants have been assigned, to assure that all outcomes and evaluations of intervention are conducted blindly, to avoid experimenter bias.
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of HDFS, Psychology, and Pediatrics

Model Details: 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.

Study Record Dates

• First Submitted: June 9, 2017
• First Posted: June 15, 2017
• Study Start: November 15, 2018
• Primary Completion: May 9, 2025
• Study Completion: May 9, 2025
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)