Recruiting

Parenting Program

Sponsor:

Georgetown University

Code:

NCT06179576

Conditions

Parenting

Eligibility Criteria

Sex: All

Age: 0 - 40

Healthy Volunteers: Accepted

Interventions

Connect to Baby

Study Details

Brief summary:

The proposed project is a randomized control trial to assess a novel 6-session parenting and coparenting intervention for low-income parents of infants. Connect to Baby (CTB) will be implemented within one of the largest federally-funded early care and education programs, Early Head Start (EHS), in Washington, DC. To engage both fathers and mothers, CTB recruits parents at the time of birth, capitalizing on the "magic moment" of delivery, and uses father-inclusive digital media content to engage men. A key innovation lies in the introduction and rehearsal of four interaction skills -- Noticing, Following, Talking, and Encouraging (NiFTE, pronounced "Nifty") -- to foster serve-and-return interactions with infants as well as supportive, cooperative coparenting interactions between mothers and fathers. To maximize program uptake, CTB is situated within an early education program parents already trust and attend. Additionally, the study will test hybrid program delivery with both in-person and remote sessions using video-enabled tablets to reduce scheduling and logistical barriers and thereby enhance retention. The specific aims of the project are to assess efficacy of random assignment to Hybrid delivery of CTB relative to EHS as usual at enhancing parenting and coparenting quality and parent and child wellbeing. If demonstrated to be efficacious, this program will provide Early Head Start (and other family-serving agencies) a brief cost-effective, manualized preventive intervention that could be used alone or in conjunction with other services to improve parent functioning and co-parenting, further engage fathers in programming and caregiving, and, ultimately, enhance child development.

Conditions

Parenting

Study ID

NCT06179576

Start date

Aug 1, 2023

Status verified date

Aug, 2025

Completion date

Mar 31, 2026

Anticipated

Primary completion date

Mar 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 40

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Must be a mother, father (or father figure, including same sex parent and grandparent) of an infant who is 2-24 months.
  • Must speak and read English or Spanish with sufficient fluency for completion of consent forms and questionnaires and actively participate in the intervention.

Exclusion Criteria:

• Pre-intervention assessment their score on the Woman Abuse Screening Tool (WAST) Interpersonal Violence (IPV) screener (Brown, Lent, Schmidt, \& Sas, 2000) indicates sexual or physical abuse.

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: EHS-CTB Hybrid

Dyads in the EHS-CTB hybrid condition will receive 6 individual sessions of CTB conducted by trained facilitators. The first session would be at the center, the 2nd through 5th would be remote, and 6th would be at the EHS center as a group session with other families. Sessions will occur approximately one to two weeks apart, allowing for program completion within 10 weeks. During the first in-person session, families will receive tablets with data plans and with the Zoom. They will receive a welcome pack that includes baby gifts that are used to support each session.

no intervention: EHS-CTB Digital Only

Dyads in the EHS-CTB digital only group will receive EHS early education, as well as EHS home visitation, and will have access to the CTB content via text messages, but will receive no CTB sessions. Digital content includes videos of Baby Elmo and his father and suggested activities.

Interventions

Connect to Baby

To engage both fathers and mothers, CTB recruits parents at the time of birth, capitalizing on the "magic moment" of delivery, and uses father-inclusive digital media content to engage men. A key innovation lies in the introduction and rehearsal of four interaction skills -- Noticing, Following, Talking, and Encouraging (NiFTE, pronounced "Nifty") -- to foster serve-and-return interactions with infants as well as supportive, cooperative coparenting interactions between mothers and fathers. To maximize program uptake, CTB is situated within an early education program parents already trust and attend. Additionally, the study will test hybrid program delivery with both in-person and remote sessions using video-enabled tablets to reduce scheduling and logistical barriers and thereby enhance retention.

Primary outcome measure

  • Parent Acceptance/Warmth during parent-child interactions [ Time Frame: At baseline (when families are enrolled in the study) ]
  • Parent Acceptance/Warmth during parent-child interactions [ Time Frame: 3 months ]
  • Parent Acceptance/Warmth during parent-child interactions [ Time Frame: 6 months ]
  • Parent Descriptive Language during parent-child interactions [ Time Frame: At baselined (when families enroll in the study) ]
  • Parent Descriptive Language during parent-child interactions [ Time Frame: 3 months ]
  • Parent Descriptive Language during parent-child interactions [ Time Frame: 6 months ]
  • Parent Follows child's lead during parent-child interactions [ Time Frame: At baseline (when families enroll in the study) ]
  • Parent Follows child's lead during parent-child interactions [ Time Frame: 3 months ]
  • Parent Follows child's lead during parent-child interactions [ Time Frame: 6 months ]
  • Parent Extends Child's Focus during parent-child interactions [ Time Frame: At baseline (when families enroll in the study ]
  • Parent Extends Child's Focus during parent-child interactions [ Time Frame: 3 months ]
  • Parent Extends Child's Focus during parent-child interactions [ Time Frame: 6 months ]
  • Parent restricts child during parent-child interactions [ Time Frame: At baseline (when families enroll in the study) ]
  • Parent restricts child during parent-child interactions [ Time Frame: 3 months ]
  • Parent restricts child during parent-child interactions [ Time Frame: 6 months ]
  • Parent criticizes child during parent-child interactions [ Time Frame: At baseline (when families enroll in the study) ]
  • Parent criticizes child during parent-child interactions [ Time Frame: 3 months ]
  • Parent criticizes child during parent-child interactions [ Time Frame: 6 months ]
  • Coparenting Quality:mother-father pleasure in coparenting [ Time Frame: At baseline (when families enroll in the study) ]
  • Coparenting Quality:mother-father pleasure in coparenting [ Time Frame: 3 months ]
  • Coparenting Quality:mother-father pleasure in coparenting [ Time Frame: 6 months ]
  • Coparenting Quality: displeasure in coparenting [ Time Frame: At baseline (when families enroll in the study) ]
  • Coparenting Quality: displeasure in coparenting [ Time Frame: 3 months ]
  • Coparenting Quality: displeasure in coparenting [ Time Frame: 6 months ]
  • Coparenting Quality: interactiveness [ Time Frame: at baseline (when families enroll in the study) ]
  • Coparenting Quality: interactiveness [ Time Frame: 3 months ]
  • Coparenting Quality: interactiveness [ Time Frame: 6 months ]
  • Coparenting Quality: cooperation [ Time Frame: At baseline (when families enroll in the study) ]
  • Coparenting Quality: cooperation [ Time Frame: 3 months ]
  • Coparenting Quality: cooperation [ Time Frame: 6 months ]
  • Coparenting Quality: competition [ Time Frame: At baseline (when families enroll in the study) ]
  • Coparenting Quality: competition [ Time Frame: 3 months ]
  • Coparenting Quality: competition [ Time Frame: 6 months ]
  • Coparenting Relationship Scale [ Time Frame: At baseline (when families enroll in the study) ]
  • Coparenting Relationship Scale [ Time Frame: 3 months ]
  • Coparenting Relationship Scale [ Time Frame: 6 months ]
  • Father Engagement Scale [ Time Frame: At baseline (when families enroll in the study) ]
  • Father Engagement Scale [ Time Frame: 3 months ]
  • Father Engagement Scale [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Locations

Child Development and Social Policy Lab

Recruiting

Washington D.C., District of Columbia, United States, 20057

Contacts

More Information

Sponsor

Georgetown University

Last update posted

Aug 19, 2025

Last verified

Aug, 2025

Keywords

  • Parent Education

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Georgetown University on 2025-08-19.