Connect to Baby Program for Parenting

(CTB Trial)

Recruiting at 1 trial location

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new program called "Connect to Baby," which aims to improve parenting and co-parenting skills for low-income parents of infants. The program teaches four key interaction skills to enhance the quality of interactions between parents and their babies, as well as between mothers and fathers. To evaluate the program's effectiveness, some families will participate in both in-person and remote sessions, while others will access content digitally without sessions. Parents with an infant between 2 and 24 months old who can communicate in English or Spanish are ideal candidates for this trial. As an unphased trial, this study offers a unique opportunity for parents to enhance their skills and positively impact their child's development.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on parenting skills rather than medical treatments.

What prior data suggests that this parenting intervention is safe for families?

Research shows that the Connect to Baby (CTB) program aims to improve parenting and coparenting through interactive sessions. The program uses communication and play to strengthen the bond between parents and children. With no medications or medical procedures involved, safety risks remain minimal.

The CTB program offers a non-invasive educational approach. Similar parenting programs have been well-received in the past. Participants often report positive experiences, as these programs focus on enhancing family interactions. Given the program's nature, serious negative effects are unlikely.

In summary, the CTB program is designed to be safe and supportive for families, focusing on building strong connections without introducing significant risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Connect to Baby (CTB) program for parenting because it offers a flexible and innovative approach to early childhood development and parental engagement. Unlike traditional parenting education that often relies on in-person classes, the EHS-CTB Hybrid model combines both in-person and remote sessions, providing families with greater accessibility and convenience. Additionally, the use of digital tools like tablets and video content allows for a more interactive and personalized learning experience. This blend of technology and personal interaction aims to enhance the effectiveness of parenting support, potentially making it more impactful than existing methods.

What evidence suggests that the Connect to Baby program is effective for enhancing parenting and coparenting quality?

Research has shown that programs like Connect to Baby (CTB), which participants in this trial may experience, can greatly enhance how parents and co-parents interact with their children. Studies have found that these programs help parents and children form strong bonds through talking and playing together. These skills are linked to better child development and stronger parent-child relationships. In this trial, some participants will receive the EHS-CTB Hybrid, which includes individual and group sessions, while others will access the EHS-CTB Digital Only content via text messages. The Early Learning Project notes that involving both fathers and mothers through digital media in CTB encourages teamwork in parenting. Overall, evidence suggests that the Connect to Baby program is promising for improving parenting quality and child well-being. ^{2 3 4 6 7}

Who Is on the Research Team?

Rebecca Ryan, PhD

Principal Investigator

Georgetown University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/76/NCT06179576/Prot_000.pdf

Connect to Baby: A Pilot Study of a Parenting and ... In exploratory analyses, parenting and coparenting quality will be tested as mediators and child sex as moderator of effects on secondary outcomes. If ...

2. elp.georgetown.edu elp.georgetown.edu/project/connect-to-baby/

Connect to Baby - The Early Learning Project Connect to Baby (CTB) is a free program that uses communication and play to build strong connections between parents and children.

3. homvee.acf.hhs.gov homvee.acf.hhs.gov/studies?citation=&model%5B503%5D=503&f%5B0%5D=model%3A272&f%5B1%5D=model%3A600

Research Manuscript Database A responsive parenting intervention: The optimal timing across early childhood for impacting maternal behaviors and child outcomes. Developmental Psychology ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8109838/

Parenting interventions to promote early child development ... We conducted a global systematic review and meta-analysis to evaluate the effectiveness of parenting interventions on ECD and parenting outcomes.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9204393/

Parent-child Relationship Outcomes of the Incredible Years ... This paper examines the effects of the Incredible Years Parents and Babies (IYPB) program on the parent-child relationship at post-intervention

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06179576

Connect to Baby: A Pilot Study of a Parenting and ... The proposed project is a randomized control trial to assess a novel 6-session parenting and coparenting intervention for low-income parents of infants.

7. withpower.com withpower.com/trial/phase-parenting-7-2023-7d813

Connect to Baby Program for Parenting (CTB 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.