Connect to Baby Program for Parenting

(CTB Trial)

Overseen By Rebecca Ryan, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Georgetown University

Disqualifiers: Interpersonal violence, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

200 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Rebecca Ryan, PhD

Principal Investigator

Georgetown University

Eligibility Criteria

This trial is for low-income parents of infants enrolled in Early Head Start in Washington, DC. It's designed to help both mothers and fathers improve parenting skills right after the birth of their child. Parents must be willing to participate together and attend a mix of in-person and remote sessions.

Inclusion Criteria

I am a parent or guardian of an infant aged 2-24 months.

I can speak and read English or Spanish well enough for medical forms and participation.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive a 6-session parenting and coparenting intervention, with sessions delivered both in-person and remotely.

10 weeks

6 sessions (1 in-person, 4 remote, 1 group session in-person)

Post-assessment

Participants undergo assessments to evaluate the efficacy of the intervention on parenting and coparenting quality.

3 months post-random assignment

Follow-up

Participants are monitored for secondary outcomes such as parent mental health and child socioemotional and language development.

6 months post-random assignment

Treatment Details

Interventions

• Connect to Baby

Trial Overview The 'Connect to Baby' program is being tested, which includes six sessions aimed at enhancing parenting and coparenting through interaction skills like Noticing, Following, Talking, Encouraging (NiFTE). The study compares this new approach with the usual Early Head Start programs.

Participant Groups

Group I: EHS-CTB Hybrid Experimental Treatment 1 Intervention

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.

Group II: EHS-CTB Digital Only Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Georgetown University

Lead Sponsor

Trials

355

Recruited

142,000+