SleepSIESTA-FFNCT03187561
Coparenting, Infant Sleep, and Infant Development
A study testing Infant sleep-adapted coparenting intervention in people with Sleep and Parenting, run by Penn State University at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 1 month to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep, Parenting, Marital Relationship
- What is being tested?
- Infant sleep-adapted coparenting intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2018to 9 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Sleep, Parenting, Marital Relationship, Parent-Child Relations
- Being tested
- Infant sleep-adapted coparenting intervention
- Keywords
- Sleep, Parenting, Marital relationship, Parent-child relations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infant sleep-adapted coparenting interventionBehavioural
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 group | Role | What they receive |
|---|---|---|
| Family Foundations (FF) | Experimental | The original Family Foundations transition-to-parenthood coparenting intervention will be implemented to all participants assigned to this arm Receives: 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. Receives: Behavioral: Infant sleep-adapted coparenting intervention |
| Control | Other | Participants in this arm will not receive either intervention. Receives: Behavioral: Infant sleep-adapted coparenting intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall coparenting quality
Quality of coparenting
Measured: 12 months post-partum
Quality of coparenting around infant sleep contexts
Quality of coparenting regarding decisions parents make about infant sleep
Measured: 1 month post-partum
Quality of infant sleep
Infant sleep quality from actigraphy and infant sleep diaries reported by parents
Measured: 6 months post-partum
Quality of parent sleep
Sleep quality for each parent, from actigraphy and sleep diary information
Measured: 6 months post-partum
Attachment Q-Set
Quality of infant attachment to mother
Measured: 12 months post-partum
Attachment Q-Set
Quality of infant attachment to father
Measured: 12 months post-partum
Infant-Toddler Social and Emotional Assessment (ITSEA)
Behavioral problems and competencies in infants
Measured: 12 months post-partum
Secondary outcomes (2)
Maternal depressive symptoms (Beck Depression Inventory)
Depressive symptoms reported by mothers
Measured: 12 months post-partum
Descriptive In-home Survey of Chaos - Observer ReporteD (DISCORD)
Household chaos, observed, in families
Measured: 1 month post-partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2017
- Study start15 Nov 2018
- Primary completion9 May 2025
- Study completion9 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- 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 blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Douglas M. Teti, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03187561
- Sponsor's protocol ID
- STUDY00006724
- Other IDs
- R01HD088566
- Acronym
- SIESTA-FF
- Status last verified
- May 2025
- First submitted
- 9 Jun 2017
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coparenting, Infant Sleep, and Infant Development
- ClinicalTrials.gov ID
- NCT03187561
- Acronym / sponsor ID
- SIESTA-FF / STUDY00006724
- Conditions
- Sleep, Parenting, Marital Relationship, Parent-Child Relations
- Keywords
- Sleep, Parenting, Marital relationship, Parent-child relations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 15 Nov 2018 (actual)
- Primary completion
- 9 May 2025 (actual)
- Study completion
- 9 May 2025 (actual)
- First posted
- 15 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Family Foundations (FF) | Experimental | Behavioral: Infant sleep-adapted coparenting interventionThe original Family Foundations transition-to-parenthood coparenting intervention will be implemented to all participants assigned to this arm |
| Sleep-adapted Family Foundations (FF+) | Experimental | Behavioral: Infant sleep-adapted coparenting interventionA 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. |
| Control | Other | Behavioral: Infant sleep-adapted coparenting interventionParticipants in this arm will not receive either intervention. |
Who may qualify
- Ages
- 1 month to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infant sleep-adapted coparenting interventionThe 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. | Behavioural | Control, Family Foundations (FF), Sleep-adapted Family Foundations (FF+) |
Primary outcome
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
2 secondary outcomes
Maternal depressive symptoms (Beck Depression Inventory)
Time frame: 12 months post-partum
Descriptive In-home Survey of Chaos - Observer ReporteD (DISCORD)
Time frame: 1 month post-partum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infant sleep-adapted coparenting intervention in people with Sleep and Parenting, run by Penn State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall coparenting quality (time frame: 12 months post-partum). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2025.