NCT06179576

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
5 months until next milestone

First Posted

Study publicly available on registry

December 22, 2023

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

August 19, 2025

Status Verified

August 1, 2025

Enrollment Period

2.7 years

First QC Date

May 18, 2023

Last Update Submit

August 18, 2025

Conditions

Parenting

Keywords

Parent Education

Outcome Measures

Primary Outcomes (39)

  • Parent Acceptance/Warmth during parent-child interactions

    Qualitative rating (0-4 scale) of as coded from a 25 minute parent-child interaction

    At baseline (when families are enrolled in the study)

  • Parent Acceptance/Warmth during parent-child interactions

    Qualitative rating (0-4 scale) as coded from a 25 minute parent-child interaction

    3 months

  • Parent Acceptance/Warmth during parent-child interactions

    Positive parenting behaviors as coded from a 25 minute parent-child interaction

    6 months

  • Parent Descriptive Language during parent-child interactions

    Qualitative rating (0-4 scale) of as coded from a 25 minute parent-child interaction

    At baselined (when families enroll in the study)

  • Parent Descriptive Language during parent-child interactions

    Qualitative rating (0-4 scale) of as coded from a 25 minute parent-child interaction

    3 months

  • Parent Descriptive Language during parent-child interactions

    Qualitative rating (0-4 scale) of as coded from a 25 minute parent-child interaction

    6 months

  • Parent Follows child's lead during parent-child interactions

    Qualitative rating (0-4 scale) of as coded from a 25 minute parent-child interaction

    At baseline (when families enroll in the study)

  • Parent Follows child's lead during parent-child interactions

    Qualitative rating (0-4 scale) of as coded from a 25 minute parent-child interaction

    3 months

  • Parent Follows child's lead during parent-child interactions

    Qualitative rating (0-4 scale) of as coded from a 25 minute parent-child interaction

    6 months

  • Parent Extends Child's Focus during parent-child interactions

    Qualitative rating (0-4 scale) of as coded from a 25 minute parent-child interaction

    At baseline (when families enroll in the study

  • Parent Extends Child's Focus during parent-child interactions

    Qualitative rating (0-4 scale) of as coded from a 25 minute parent-child interaction

    3 months

  • Parent Extends Child's Focus during parent-child interactions

    Qualitative rating (0-4 scale) as coded from a 25 minute parent-child interaction

    6 months

  • Parent restricts child during parent-child interactions

    Qualitative rating (0-4 scale) of as coded from a 25 minute parent-child interaction

    At baseline (when families enroll in the study)

  • Parent restricts child during parent-child interactions

    Qualitative rating (0-4 scale) of as coded from a 25 minute parent-child interaction

    3 months

  • Parent restricts child during parent-child interactions

    Qualitative rating (0-4 scale) of as coded from a 25 minute parent-child interaction

    6 months

  • Parent criticizes child during parent-child interactions

    Qualitative rating (0-4 scale) of as coded from a 25 minute parent-child interaction

    At baseline (when families enroll in the study)

  • Parent criticizes child during parent-child interactions

    Qualitative rating (0-4 scale) of as coded from a 25 minute parent-child interaction

    3 months

  • Parent criticizes child during parent-child interactions

    Qualitative rating (0-4 scale) of as coded from a 25 minute parent-child interaction

    6 months

  • Coparenting Quality:mother-father pleasure in coparenting

    Qualitative rating scale (1-5) as coded from a 25 minutes mother-father-child interaction

    At baseline (when families enroll in the study)

  • Coparenting Quality:mother-father pleasure in coparenting

    Qualitative rating scale (1-5) as coded from a 25 minutes mother-father-child interaction

    3 months

  • Coparenting Quality:mother-father pleasure in coparenting

    Qualitative rating scale (1-5) as coded from a 25 minutes mother-father-child interaction

    6 months

  • Coparenting Quality: displeasure in coparenting

    Qualitative rating scale (1-5) as coded from a 25 minutes mother-father-child interaction

    At baseline (when families enroll in the study)

  • Coparenting Quality: displeasure in coparenting

    Qualitative rating scale (1-5) as coded from a 25 minutes mother-father-child interaction

    3 months

  • Coparenting Quality: displeasure in coparenting

    Qualitative rating scale (1-5) as coded from a 25 minutes mother-father-child interaction

    6 months

  • Coparenting Quality: interactiveness

    Qualitative rating scale (1-5) as coded from a 25 minutes mother-father-child interaction

    at baseline (when families enroll in the study)

  • Coparenting Quality: interactiveness

    Qualitative rating scale (1-5) as coded from a 25 minutes mother-father-child interaction

    3 months

  • Coparenting Quality: interactiveness

    Qualitative rating scale (1-5) as coded from a 25 minutes mother-father-child interaction

    6 months

  • Coparenting Quality: cooperation

    Qualitative rating scale (1-5) as coded from a 25 minutes mother-father-child interaction

    At baseline (when families enroll in the study)

  • Coparenting Quality: cooperation

    Qualitative rating scale (1-5) as coded from a 25 minutes mother-father-child interaction

    3 months

  • Coparenting Quality: cooperation

    Qualitative rating scale (1-5) as coded from a 25 minutes mother-father-child interaction

    6 months

  • Coparenting Quality: competition

    Qualitative rating scale (1-5) as coded from a 25 minutes mother-father-child interaction

    At baseline (when families enroll in the study)

  • Coparenting Quality: competition

    Qualitative rating scale (1-5) as coded from a 25 minutes mother-father-child interaction

    3 months

  • Coparenting Quality: competition

    Qualitative rating scale (1-5) as coded from a 25 minutes mother-father-child interaction

    6 months

  • Coparenting Relationship Scale

    Coparenting relationship scale measuring quality of communication, 14 items, scale 1-6.

    At baseline (when families enroll in the study)

  • Coparenting Relationship Scale

    Coparenting relationship scale measuring quality of communication, 14 items, scale 1-6.

    3 months

  • Coparenting Relationship Scale

    Coparenting relationship scale measuring quality of communication, 14 items, scale 1-6.

    6 months

  • Father Engagement Scale

    Father Engagement Scale, measuring fathers' engagement in 11 activities with infants, scale 0 - 4

    At baseline (when families enroll in the study)

  • Father Engagement Scale

    Father Engagement Scale, measuring fathers' engagement in 11 activities with infants, scale 0 - 4

    3 months

  • Father Engagement Scale

    Father Engagement Scale, measuring fathers' engagement in 11 activities with infants, scale 0 - 4

    6 months

Secondary Outcomes (17)

  • Parent mental health

    At baseline (when families enroll in the study)

  • Parent mental health

    3 months

  • Parent mental health

    6 months

  • Parent self efficacy

    at baseline (when families enroll in the study)

  • Parent self efficacy

    3 months

  • +12 more secondary outcomes

Study Arms (2)

EHS-CTB Hybrid

EXPERIMENTAL

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.

Behavioral: Connect to Baby

EHS-CTB Digital Only

NO 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.

Interventions

Connect to BabyBEHAVIORAL

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.

EHS-CTB Hybrid

Eligibility Criteria

Age2 Months - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Child Development and Social Policy Lab

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

RECRUITING

Related Publications (7)

  • Richeda B, Smith K, Perkins E, et al. Baby Elmo Leads Dads Back to the Nursery: How a Relationship-Based Intervention for Incarcerated Fathers Enhances Father and Child Outcomes. ZERO TO THREE. 2015;35(5):25-35

    BACKGROUND

  • Feinberg ME, Jones DE, Kan ML, Goslin MC. Effects of family foundations on parents and children: 3.5 years after baseline. J Fam Psychol. 2010 Oct;24(5):532-42. doi: 10.1037/a0020837.

    PMID: 20954763BACKGROUND

  • Feinberg ME, Jones DE, Hostetler ML, Roettger ME, Paul IM, Ehrenthal DB. Couple-Focused Prevention at the Transition to Parenthood, a Randomized Trial: Effects on Coparenting, Parenting, Family Violence, and Parent and Child Adjustment. Prev Sci. 2016 Aug;17(6):751-64. doi: 10.1007/s11121-016-0674-z.

    PMID: 27334116BACKGROUND

  • Barr R, Brito N, Zocca J, Reina S, Rodriguez J, Shauffer C. The Baby Elmo Program: Improving teen father-child interactions within juvenile justice facilities. Children and Youth Services Review. 2011;33(9):1555-1562. doi:10.1016/j.childyouth.2011.03.020

    BACKGROUND

  • Barr R, Morin M, Brito N, Richeda B, Rodriguez J, Shauffer C. Delivering services to incarcerated teen fathers: a pilot intervention to increase the quality of father-infant interactions during visitation. Psychol Serv. 2014 Feb;11(1):10-21. doi: 10.1037/a0034877. Epub 2013 Nov 18.

    PMID: 24246016BACKGROUND

  • Feinberg ME, Kan ML. Establishing family foundations: intervention effects on coparenting, parent/infant well-being, and parent-child relations. J Fam Psychol. 2008 Apr;22(2):253-63. doi: 10.1037/0893-3200.22.2.253.

    PMID: 18410212BACKGROUND

  • Feinberg ME, Jones DE. Experimental Support for a Family Systems Approach to Child Development: Multiple Mediators of Intervention Effects across the Transition to Parenthood. Couple Family Psychol. 2018 Jun;7(2):63-75. doi: 10.1037/cfp0000100.

    PMID: 30858994BACKGROUND

Study Officials

  • Rebecca Ryan, PhD

    Georgetown University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rebecca Ryan, PhD

CONTACT

202-687-2215rmr64@georgetown.edu

Rachel Barr, PhD

CONTACT

rfb5@georgetown.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Families will be randomly assigned to the treatment or control condition upon enrollment in the study. Because it is an intervention, administered by facilitators, the facilitators and parents will be aware of the treatment families status. The investigators will know which families are receiving the treatment or not because they will need to manage the progress of the intervention and the progress of data collection. Those blind to treatment status will be the data collectors, who will administer all parent surveys and objective measures, including the videotaped parent-child interactions. The coders of the videotaped parent-child interactions will also be blind to treatment status.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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. 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 the CTB App, but will receive no CTB sessions. Content includes videos of baby Elmo and his father and suggested activities.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 18, 2023

First Posted

December 22, 2023

Study Start

August 1, 2023

Primary Completion

March 31, 2026

Study Completion

March 31, 2026

Last Updated

August 19, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share

This application requests support to collect and maintain a database of contact information, pre- and post-random assignment interview and video records for 200 participants and session recordings for 100 participants for supervision and fidelity tracking. Georgetown University Psychology department will serve as the Data Coordinating Center for this project, utilizing the REDCap database system for secure storage and sharing of research data. Video records will be securely stored and shared on Databrary (www.databrary.org), which is a video repository. While video records require explicit permission, deidentified datasets can also be made available in shared volumes on Databrary and on the open science framework https://osf.io/ to increase accessibility to non-clinical researchers.

Shared Documents
STUDY PROTOCOL
Time Frame
Data will be made available 12 months after the study completion date.
Access Criteria
The deidentified data will be available to any researchers with access to Databrary or OSF.
More information

Locations

US(1)