Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03187561
Recruitment Status : Recruiting
First Posted : June 15, 2017
Last Update Posted : June 18, 2019
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Douglas M. Teti, Penn State University

Tracking Information
First Submitted Date  ICMJE June 9, 2017
First Posted Date  ICMJE June 15, 2017
Last Update Posted Date June 18, 2019
Actual Study Start Date  ICMJE May 1, 2018
Estimated Primary Completion Date February 28, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 12, 2017)
  • Overall coparenting quality [ Time Frame: 12 months post-partum ]
    Quality of coparenting
  • Quality of coparenting around infant sleep contexts [ Time Frame: 1 month post-partum ]
    Quality of coparenting regarding decisions parents make about infant sleep
  • Quality of infant sleep [ Time Frame: 6 months post-partum ]
    Infant sleep quality from actigraphy and infant sleep diaries reported by parents
  • Quality of parent sleep [ Time Frame: 6 months post-partum ]
    Sleep quality for each parent, from actigraphy and sleep diary information
  • Attachment Q-Set [ Time Frame: 12 months post-partum ]
    Quality of infant attachment to mother
  • Attachment Q-Set [ Time Frame: 12 months post-partum ]
    Quality of infant attachment to father
  • Infant-Toddler Social and Emotional Assessment (ITSEA) [ Time Frame: 12 months post-partum ]
    Behavioral problems and competencies in infants
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 12, 2017)
  • Maternal depressive symptoms (Beck Depression Inventory) [ Time Frame: 12 months post-partum ]
    Depressive symptoms reported by mothers
  • Descriptive In-home Survey of Chaos - Observer ReporteD (DISCORD) [ Time Frame: 1 month post-partum ]
    Household chaos, observed, in families
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 12, 2017)
Paternal depressive symptoms (Beck Depression Inventory) [ Time Frame: 12 months post-partum ]
Depressive symptoms reported by fathers
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Coparenting, Infant Sleep, and Infant Development
Official Title  ICMJE Coparenting, Infant Sleep, and Infant Development
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
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.
Masking: Double (Participant, Outcomes Assessor)
Masking Description:
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.
Primary Purpose: Prevention
Condition  ICMJE
  • Sleep
  • Parenting
  • Marital Relationship
  • Parent-Child Relations
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Family Foundations (FF)
    The original Family Foundations transition-to-parenthood coparenting intervention will be implemented to all participants assigned to this arm
    Intervention: Behavioral: Infant sleep-adapted coparenting intervention
  • 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.
    Intervention: Behavioral: Infant sleep-adapted coparenting intervention
  • Control
    Participants in this arm will not receive either intervention.
    Intervention: Behavioral: Infant sleep-adapted coparenting intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 12, 2017)
216
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 28, 2022
Estimated Primary Completion Date February 28, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Month to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Douglas M Teti, Ph.D. 814-863-9570 dmt16@psu.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03187561
Other Study ID Numbers  ICMJE STUDY00006724
R01HD088566 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Douglas M. Teti, Penn State University
Study Sponsor  ICMJE Penn State University
Collaborators  ICMJE Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators  ICMJE Not Provided
PRS Account Penn State University
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP