ParentingCTBNCT06179576
Connect to Baby: A Pilot Study of a Parenting and Coparenting Program
A study testing Connect to Baby in people with Parenting, run by Georgetown University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 months to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Parenting
- What is being tested?
- Connect to Baby
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2023to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 2 months to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Rachel Barr, PhD contact
United States1 site, 1 recruiting
- Recruiting
Child Development and Social Policy Lab
Washington D.C., District of Columbia, 20057
Rebecca Ryan, 917-518-6426, rebeccamarieryan@gmail.com
About this study
Official title: Connect to Baby: A Pilot Study of a Parenting and Coparenting Program for New Parents
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.
Read the detailed description
Overview:
The proposed project is a randomized control trial to assess the effectiveness of a novel 6-session parenting and coparenting intervention for low-income parents of infants designed by the program developers of Just Beginning (JB) and Family Foundations (FF). Connect to Baby (CTB) blends and builds upon these two evidence-based programs and will be implemented within one of the largest federally-funded early care and education programs, Early Head Start (EHS), in Washington, DC. CTB's approach recognizes that although many existing interventions aim to increase parenting quality in low-income contexts, the vast majority yield only modest effects that often fade. These mixed findings stem, in part, from three key weaknesses in existing programs: 1) a focus on mothers, rather than mothers and fathers; 2) a focus on the parent-child relationship to the exclusion of the coparenting relationship; 3) low program recruitment and retention rates. The co-PIs have successfully piloted a program that addresses these weaknesses and can be easily incorporated into programs like EHS to enhance their effects on parenting, and child development. Specifically, 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. CTB has two key targets of intervention - coparenting communication and parenting quality. By enhancing these targets, CTB aims to improve parent mental health, and child socioemotional and language outcomes. 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 program targets and both parent mental health and infant socioemotional and language outcomes. 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.
Families will be randomly assigned to CTB-EHS Hybrid and EHS-digital only conditions. There will be 100 dyads randomly assigned to each condition. The main objective of the study is to test the feasibility of the CTB-Hybrid intervention for enhancing targets of co-parenting and parenting, and outcomes of parent well-being and child language and socioemotional development. The specific aims are:
Aim 1. To assess the efficacy of CTB-Hybrid at improving program targets. One hundred and fifty families will be recruited and randomized to one of two conditions: 1) EHS-CTB Hybrid or 2) EHS-digital with CTB digital content (content delivered via the customized application). CTB is hypothesized to increase coparenting communication quality and parenting quality relative to EHS digital at 3- and 6-months post-random assignment (RA); comparing results at each time point will distinguish immediate from sustained effects of the program. Analyses will include both intent-to-treat (ITT) and treatment-on-the-treated (TOT) analyses to determine the importance of program dosage for program efficacy.
Aim 2. To assess the efficacy of CTB-Hybrid at enhancing secondary program outcomes. CTB will also be assessed with regard to parent mental health (assessed using parent self-report and a short diagnostic interview at 3- and 6-months post (RA), and child socioemotional and language outcomes at 3- and 6-months post RA (assessed using parent-report and objective ratings). In exploratory analyses, parenting and coparenting quality will be tested as mediators and child sex as moderator of effects on secondary outcomes.
Study Site:
13 EHS centers in the Washington DC region.
Recruitment, Screening, Enrollment and Informed Consent:
Participants will be recruited at the EHS centers. Informed consent will be collected remotely via zoom and using REDCAP. Given our experiences during the COVID pandemic we will also collect pre and post measures remotely via zoom. For assessment, EHS-digital only and CTB-hybrid families will pick up a packet from the EHS center that includes a data enabled tablet with a zoom link and links to REDCAP survey links and surveys completed on the tablet and a standard set of toys for the assessment. The materials will be returned to the center after the assessment is complete. Except for the child language measure, MCDI, all measures will be administered at each of the three assessment time points. Mindful of the potential burden of lengthy assessments for this high-risk population, assessments will be administered via two Zoom calls that can be done via mobile phone or tablet separated by one week if needed or requested. Non-proprietary measures will be entered into REDCAP and administered on a tablet or mobile phone.
Study Procedures and Evaluations:
Overall study duration and duration of participant involvement. The intervention is 10 weeks long. Participants will also be involved in a pre-assessment, a post-assessment (3 months post random assignment) and a follow-up (6 months post random assignment)
Retention of Study Subjects:
The hybrid delivery is linked to a trusted service (EHS) and the hybrid delivery allows for flexibility in scheduling.
Fidelity Monitoring:
Each CTB facilitator will participate in a two-day training to learn to use the manual and understand the program's principles and how to effectively use the technology to deliver the content remotely run by the lead CTB facilitator. Once facilitators complete training, the first six sessions each facilitator delivers will be video-recorded, via zoom, for fidelity review. During implementation, every 10th session will be recorded and reviewed for fidelity. The trainer, an LCSW will provide individual and group feedback on the extent to which the facilitator followed the manual and engaged parents effectively. Feedback will be based on video review and a fidelity coding scheme created for CTB in which facilitators are scored for session component completion, and 7 positive engagement, 7 negative engagement criteria, every 30 seconds. Pilot data showed that reliability on the fidelity scheme was high (kappa > .7) as was session fidelity and facilitator quality, with low levels of negative engagement and high levels of positive engagement. Any facilitator not delivering CTB with fidelity will receive a refresher training. Moreover, a clinical supervisor and trainer will be available via phone.
- Conditions
- Parenting
- Being tested
- Connect to Baby
- Keywords
- Parent Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Connect to BabyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parent Acceptance/Warmth during parent-child interactions
Qualitative rating (0-4 scale) of as coded from a 25 minute parent-child interaction
Measured: 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
Measured: 3 months
Parent Acceptance/Warmth during parent-child interactions
Positive parenting behaviors as coded from a 25 minute parent-child interaction
Measured: 6 months
Parent Descriptive Language during parent-child interactions
Qualitative rating (0-4 scale) of as coded from a 25 minute parent-child interaction
Measured: 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
Measured: 3 months
Parent Descriptive Language during parent-child interactions
Qualitative rating (0-4 scale) of as coded from a 25 minute parent-child interaction
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 6 months
Parent restricts child during parent-child interactions
Qualitative rating (0-4 scale) of as coded from a 25 minute parent-child interaction
Measured: 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
Measured: 3 months
Parent restricts child during parent-child interactions
Qualitative rating (0-4 scale) of as coded from a 25 minute parent-child interaction
Measured: 6 months
Parent criticizes child during parent-child interactions
Qualitative rating (0-4 scale) of as coded from a 25 minute parent-child interaction
Measured: 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
Measured: 3 months
Parent criticizes child during parent-child interactions
Qualitative rating (0-4 scale) of as coded from a 25 minute parent-child interaction
Measured: 6 months
Coparenting Quality:mother-father pleasure in coparenting
Qualitative rating scale (1-5) as coded from a 25 minutes mother-father-child interaction
Measured: 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
Measured: 3 months
Coparenting Quality:mother-father pleasure in coparenting
Qualitative rating scale (1-5) as coded from a 25 minutes mother-father-child interaction
Measured: 6 months
Coparenting Quality: displeasure in coparenting
Qualitative rating scale (1-5) as coded from a 25 minutes mother-father-child interaction
Measured: 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
Measured: 3 months
Coparenting Quality: displeasure in coparenting
Qualitative rating scale (1-5) as coded from a 25 minutes mother-father-child interaction
Measured: 6 months
Coparenting Quality: interactiveness
Qualitative rating scale (1-5) as coded from a 25 minutes mother-father-child interaction
Measured: 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
Measured: 3 months
Coparenting Quality: interactiveness
Qualitative rating scale (1-5) as coded from a 25 minutes mother-father-child interaction
Measured: 6 months
Coparenting Quality: cooperation
Qualitative rating scale (1-5) as coded from a 25 minutes mother-father-child interaction
Measured: 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
Measured: 3 months
Coparenting Quality: cooperation
Qualitative rating scale (1-5) as coded from a 25 minutes mother-father-child interaction
Measured: 6 months
Coparenting Quality: competition
Qualitative rating scale (1-5) as coded from a 25 minutes mother-father-child interaction
Measured: 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
Measured: 3 months
Coparenting Quality: competition
Qualitative rating scale (1-5) as coded from a 25 minutes mother-father-child interaction
Measured: 6 months
Coparenting Relationship Scale
Coparenting relationship scale measuring quality of communication, 14 items, scale 1-6.
Measured: At baseline (when families enroll in the study)
Coparenting Relationship Scale
Coparenting relationship scale measuring quality of communication, 14 items, scale 1-6.
Measured: 3 months
Coparenting Relationship Scale
Coparenting relationship scale measuring quality of communication, 14 items, scale 1-6.
Measured: 6 months
Father Engagement Scale
Father Engagement Scale, measuring fathers' engagement in 11 activities with infants, scale 0 - 4
Measured: 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
Measured: 3 months
Father Engagement Scale
Father Engagement Scale, measuring fathers' engagement in 11 activities with infants, scale 0 - 4
Measured: 6 months
Secondary outcomes (17)
Parent mental health
Center for Epidemiologic Studies Depression Scale Revised, scale to measure parent depression symptoms (10-items), scale 0 - 3
Measured: At baseline (when families enroll in the study)
Parent mental health
Center for Epidemiologic Studies Depression Scale Revised, scale to measure parent depression symptoms (10-items), scale 0 - 3
Measured: 3 months
Parent mental health
Center for Epidemiologic Studies Depression Scale Revised, scale to measure parent depression symptoms (10-items), scale 0 - 3
Measured: 6 months
Parent self efficacy
Parental Sense of Competence Scale, 17 items, scale 1 - 6
Measured: at baseline (when families enroll in the study)
Parent self efficacy
Parental Sense of Competence Scale, 17 items, scale 1 - 6
Measured: 3 months
Parent self efficacy
Parental Sense of Competence Scale, 17 items, scale 1 - 6
Measured: 6 months
Child language development
Videotaped parent-infant play task coded using the family interactions using the Individual Growth and Development Indicators (IGDI) Early Communication Indicator (ECI), which codes expressive communication for children between 3 and 36 months.
Measured: At baseline (when families enroll in the study)
Child language development
Videotaped parent-infant play task coded using the family interactions using the Individual Growth and Development Indicators (IGDI) Early Communication Indicator (ECI), which codes expressive communication for children between 3 and 36 months.
Measured: 3 months
Child language development
Videotaped parent-infant play task coded using the family interactions using the Individual Growth and Development Indicators (IGDI) Early Communication Indicator (ECI), which codes expressive communication for children between 3 and 36 months.
Measured: 6 months
Child socioemotional development
The Brief Infant Toddler Social Emotional Assessment (BITSEA), which assesses behavior problems and competencies, 42 items, scale 0 - 2
Measured: at baseline (when families enroll in the study)
Child socioemotional development
The Brief Infant Toddler Social Emotional Assessment (BITSEA), which assesses behavior problems and competencies, 42 items, scale 0 - 2
Measured: 3 months
Child socioemotional development
The Brief Infant Toddler Social Emotional Assessment (BITSEA), which assesses behavior problems and competencies, 42 items, scale 0 - 2
Measured: 6 months
Parent Generalized Anxiety Scale
Scale to measure parent anxiety, Generalized Anxiety Scale, 7 items, scale 0 - 3
Measured: At baseline (when families enroll in the study)
Parent Generalized Anxiety Scale
Scale to measure parent anxiety, Generalized Anxiety Scale, 7 items, scale 0 - 3
Measured: 3 months
Parent Generalized Anxiety Scale
Scale to measure parent anxiety, Generalized Anxiety Scale, 7 items, scale 0 - 3
Measured: 6 months
Child Language Development
Scale measuring child expressive and receptive language development, MacArthur-Bates Communicative Development Inventories (MCDI) for infants/toddlers, 89-word vocabulary checklist, 0 - 178 (each item has 0 - 2 scale)
Measured: 3 months
Child Language Development
Scale measuring child expressive and receptive language development, MacArthur-Bates Communicative Development Inventories (MCDI) for infants/toddlers, 89-word vocabulary checklist, 0 - 178 (each item has 0 - 2 scale)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2023
- Study start1 Aug 2023
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for ParentingStudies of the same condition, open and under way.
- More trials run by Georgetown UniversityThe sponsor's other registered studies.
- 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
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rebecca Ryan, Georgetown University
- Investigators
- Rebecca Ryan, PhD, Principal investigator, Georgetown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06179576
- Sponsor's protocol ID
- R21HD108499
- Acronym
- CTB
- Status last verified
- Aug 2025
- First submitted
- 18 May 2023
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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
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.
PubMed 20954763Feinberg 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.
PubMed 27334116Barr 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
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.
PubMed 24246016Feinberg 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.
PubMed 18410212Feinberg 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.
PubMed 30858994
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Connect to Baby: A Pilot Study of a Parenting and Coparenting Program for New Parents
- ClinicalTrials.gov ID
- NCT06179576
- Acronym / sponsor ID
- CTB / R21HD108499
- Conditions
- Parenting
- Keywords
- Parent Education
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 22 Dec 2023 (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.
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.
Detailed description
Overview:
The proposed project is a randomized control trial to assess the effectiveness of a novel 6-session parenting and coparenting intervention for low-income parents of infants designed by the program developers of Just Beginning (JB) and Family Foundations (FF). Connect to Baby (CTB) blends and builds upon these two evidence-based programs and will be implemented within one of the largest federally-funded early care and education programs, Early Head Start (EHS), in Washington, DC. CTB's approach recognizes that although many existing interventions aim to increase parenting quality in low-income contexts, the vast majority yield only modest effects that often fade. These mixed findings stem, in part, from three key weaknesses in existing programs: 1) a focus on mothers, rather than mothers and fathers; 2) a focus on the parent-child relationship to the exclusion of the coparenting relationship; 3) low program recruitment and retention rates. The co-PIs have successfully piloted a program that addresses these weaknesses and can be easily incorporated into programs like EHS to enhance their effects on parenting, and child development. Specifically, 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. CTB has two key targets of intervention - coparenting communication and parenting quality. By enhancing these targets, CTB aims to improve parent mental health, and child socioemotional and language outcomes. 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 program targets and both parent mental health and infant socioemotional and language outcomes. 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.
Families will be randomly assigned to CTB-EHS Hybrid and EHS-digital only conditions. There will be 100 dyads randomly assigned to each condition. The main objective of the study is to test the feasibility of the CTB-Hybrid intervention for enhancing targets of co-parenting and parenting, and outcomes of parent well-being and child language and socioemotional development. The specific aims are:
Aim 1. To assess the efficacy of CTB-Hybrid at improving program targets. One hundred and fifty families will be recruited and randomized to one of two conditions: 1) EHS-CTB Hybrid or 2) EHS-digital with CTB digital content (content delivered via the customized application). CTB is hypothesized to increase coparenting communication quality and parenting quality relative to EHS digital at 3- and 6-months post-random assignment (RA); comparing results at each time point will distinguish immediate from sustained effects of the program. Analyses will include both intent-to-treat (ITT) and treatment-on-the-treated (TOT) analyses to determine the importance of program dosage for program efficacy.
Aim 2. To assess the efficacy of CTB-Hybrid at enhancing secondary program outcomes. CTB will also be assessed with regard to parent mental health (assessed using parent self-report and a short diagnostic interview at 3- and 6-months post (RA), and child socioemotional and language outcomes at 3- and 6-months post RA (assessed using parent-report and objective ratings). In exploratory analyses, parenting and coparenting quality will be tested as mediators and child sex as moderator of effects on secondary outcomes.
Study Site:
13 EHS centers in the Washington DC region.
Recruitment, Screening, Enrollment and Informed Consent:
Participants will be recruited at the EHS centers. Informed consent will be collected remotely via zoom and using REDCAP. Given our experiences during the COVID pandemic we will also collect pre and post measures remotely via zoom. For assessment, EHS-digital only and CTB-hybrid families will pick up a packet from the EHS center that includes a data enabled tablet with a zoom link and links to REDCAP survey links and surveys completed on the tablet and a standard set of toys for the assessment. The materials will be returned to the center after the assessment is complete. Except for the child language measure, MCDI, all measures will be administered at each of the three assessment time points. Mindful of the potential burden of lengthy assessments for this high-risk population, assessments will be administered via two Zoom calls that can be done via mobile phone or tablet separated by one week if needed or requested. Non-proprietary measures will be entered into REDCAP and administered on a tablet or mobile phone.
Study Procedures and Evaluations:
Overall study duration and duration of participant involvement. The intervention is 10 weeks long. Participants will also be involved in a pre-assessment, a post-assessment (3 months post random assignment) and a follow-up (6 months post random assignment)
Retention of Study Subjects:
The hybrid delivery is linked to a trusted service (EHS) and the hybrid delivery allows for flexibility in scheduling.
Fidelity Monitoring:
Each CTB facilitator will participate in a two-day training to learn to use the manual and understand the program's principles and how to effectively use the technology to deliver the content remotely run by the lead CTB facilitator. Once facilitators complete training, the first six sessions each facilitator delivers will be video-recorded, via zoom, for fidelity review. During implementation, every 10th session will be recorded and reviewed for fidelity. The trainer, an LCSW will provide individual and group feedback on the extent to which the facilitator followed the manual and engaged parents effectively. Feedback will be based on video review and a fidelity coding scheme created for CTB in which facilitators are scored for session component completion, and 7 positive engagement, 7 negative engagement criteria, every 30 seconds. Pilot data showed that reliability on the fidelity scheme was high (kappa > .7) as was session fidelity and facilitator quality, with low levels of negative engagement and high levels of positive engagement. Any facilitator not delivering CTB with fidelity will receive a refresher training. Moreover, a clinical supervisor and trainer will be available via phone.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| EHS-CTB Hybrid | Experimental | Behavioral: Connect to BabyDyads 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. |
| 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. |
Who may qualify
- Ages
- 2 months to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| Connect to BabyTo 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. | Behavioural | EHS-CTB Hybrid |
Primary outcome
Parent Acceptance/Warmth during parent-child interactions
Time frame: At baseline (when families are enrolled in the study)
Qualitative rating (0-4 scale) of as coded from a 25 minute parent-child interaction
Parent Acceptance/Warmth during parent-child interactions
Time frame: 3 months
Qualitative rating (0-4 scale) as coded from a 25 minute parent-child interaction
Parent Acceptance/Warmth during parent-child interactions
Time frame: 6 months
Positive parenting behaviors as coded from a 25 minute parent-child interaction
Parent Descriptive Language during parent-child interactions
Time frame: At baselined (when families enroll in the study)
Qualitative rating (0-4 scale) of as coded from a 25 minute parent-child interaction
Parent Descriptive Language during parent-child interactions
Time frame: 3 months
Qualitative rating (0-4 scale) of as coded from a 25 minute parent-child interaction
Parent Descriptive Language during parent-child interactions
Time frame: 6 months
Qualitative rating (0-4 scale) of as coded from a 25 minute parent-child interaction
Parent Follows child's lead during parent-child interactions
Time frame: At baseline (when families enroll in the study)
Qualitative rating (0-4 scale) of as coded from a 25 minute parent-child interaction
Parent Follows child's lead during parent-child interactions
Time frame: 3 months
Qualitative rating (0-4 scale) of as coded from a 25 minute parent-child interaction
Parent Follows child's lead during parent-child interactions
Time frame: 6 months
Qualitative rating (0-4 scale) of as coded from a 25 minute parent-child interaction
Parent Extends Child's Focus during parent-child interactions
Time frame: At baseline (when families enroll in the study
Qualitative rating (0-4 scale) of as coded from a 25 minute parent-child interaction
Parent Extends Child's Focus during parent-child interactions
Time frame: 3 months
Qualitative rating (0-4 scale) of as coded from a 25 minute parent-child interaction
Parent Extends Child's Focus during parent-child interactions
Time frame: 6 months
Qualitative rating (0-4 scale) as coded from a 25 minute parent-child interaction
Parent restricts child during parent-child interactions
Time frame: At baseline (when families enroll in the study)
Qualitative rating (0-4 scale) of as coded from a 25 minute parent-child interaction
Parent restricts child during parent-child interactions
Time frame: 3 months
Qualitative rating (0-4 scale) of as coded from a 25 minute parent-child interaction
Parent restricts child during parent-child interactions
Time frame: 6 months
Qualitative rating (0-4 scale) of as coded from a 25 minute parent-child interaction
Parent criticizes child during parent-child interactions
Time frame: At baseline (when families enroll in the study)
Qualitative rating (0-4 scale) of as coded from a 25 minute parent-child interaction
Parent criticizes child during parent-child interactions
Time frame: 3 months
Qualitative rating (0-4 scale) of as coded from a 25 minute parent-child interaction
Parent criticizes child during parent-child interactions
Time frame: 6 months
Qualitative rating (0-4 scale) of as coded from a 25 minute parent-child interaction
Coparenting Quality:mother-father pleasure in coparenting
Time frame: At baseline (when families enroll in the study)
Qualitative rating scale (1-5) as coded from a 25 minutes mother-father-child interaction
Coparenting Quality:mother-father pleasure in coparenting
Time frame: 3 months
Qualitative rating scale (1-5) as coded from a 25 minutes mother-father-child interaction
Coparenting Quality:mother-father pleasure in coparenting
Time frame: 6 months
Qualitative rating scale (1-5) as coded from a 25 minutes mother-father-child interaction
Coparenting Quality: displeasure in coparenting
Time frame: At baseline (when families enroll in the study)
Qualitative rating scale (1-5) as coded from a 25 minutes mother-father-child interaction
Coparenting Quality: displeasure in coparenting
Time frame: 3 months
Qualitative rating scale (1-5) as coded from a 25 minutes mother-father-child interaction
Coparenting Quality: displeasure in coparenting
Time frame: 6 months
Qualitative rating scale (1-5) as coded from a 25 minutes mother-father-child interaction
Coparenting Quality: interactiveness
Time frame: at baseline (when families enroll in the study)
Qualitative rating scale (1-5) as coded from a 25 minutes mother-father-child interaction
Coparenting Quality: interactiveness
Time frame: 3 months
Qualitative rating scale (1-5) as coded from a 25 minutes mother-father-child interaction
Coparenting Quality: interactiveness
Time frame: 6 months
Qualitative rating scale (1-5) as coded from a 25 minutes mother-father-child interaction
Coparenting Quality: cooperation
Time frame: At baseline (when families enroll in the study)
Qualitative rating scale (1-5) as coded from a 25 minutes mother-father-child interaction
Coparenting Quality: cooperation
Time frame: 3 months
Qualitative rating scale (1-5) as coded from a 25 minutes mother-father-child interaction
Coparenting Quality: cooperation
Time frame: 6 months
Qualitative rating scale (1-5) as coded from a 25 minutes mother-father-child interaction
Coparenting Quality: competition
Time frame: At baseline (when families enroll in the study)
Qualitative rating scale (1-5) as coded from a 25 minutes mother-father-child interaction
Coparenting Quality: competition
Time frame: 3 months
Qualitative rating scale (1-5) as coded from a 25 minutes mother-father-child interaction
Coparenting Quality: competition
Time frame: 6 months
Qualitative rating scale (1-5) as coded from a 25 minutes mother-father-child interaction
Coparenting Relationship Scale
Time frame: At baseline (when families enroll in the study)
Coparenting relationship scale measuring quality of communication, 14 items, scale 1-6.
Coparenting Relationship Scale
Time frame: 3 months
Coparenting relationship scale measuring quality of communication, 14 items, scale 1-6.
Coparenting Relationship Scale
Time frame: 6 months
Coparenting relationship scale measuring quality of communication, 14 items, scale 1-6.
Father Engagement Scale
Time frame: At baseline (when families enroll in the study)
Father Engagement Scale, measuring fathers' engagement in 11 activities with infants, scale 0 - 4
Father Engagement Scale
Time frame: 3 months
Father Engagement Scale, measuring fathers' engagement in 11 activities with infants, scale 0 - 4
Father Engagement Scale
Time frame: 6 months
Father Engagement Scale, measuring fathers' engagement in 11 activities with infants, scale 0 - 4
17 secondary outcomes
Parent mental health
Time frame: At baseline (when families enroll in the study)
Parent mental health
Time frame: 3 months
Parent mental health
Time frame: 6 months
Parent self efficacy
Time frame: at baseline (when families enroll in the study)
Parent self efficacy
Time frame: 3 months
Parent self efficacy
Time frame: 6 months
Child language development
Time frame: At baseline (when families enroll in the study)
Child language development
Time frame: 3 months
Child language development
Time frame: 6 months
Child socioemotional development
Time frame: at baseline (when families enroll in the study)
Child socioemotional development
Time frame: 3 months
Child socioemotional development
Time frame: 6 months
Parent Generalized Anxiety Scale
Time frame: At baseline (when families enroll in the study)
Parent Generalized Anxiety Scale
Time frame: 3 months
Parent Generalized Anxiety Scale
Time frame: 6 months
Child Language Development
Time frame: 3 months
Child Language Development
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
- BackgroundRicheda 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: PubMed 20954763Feinberg 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.
- Background: PubMed 27334116Feinberg 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.
- BackgroundBarr 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: PubMed 24246016Barr 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.
- Background: PubMed 18410212Feinberg 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.
- Background: PubMed 30858994Feinberg 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.
- Individual participant dataSharing planned: Yes. 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.
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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.
Rachel Barr, PhD contact
Rebecca Ryan, PhD principal investigator
Georgetown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Connect to Baby in people with Parenting, run by Georgetown 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 2 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 19 Aug 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rebecca Ryan, PhD (202-687-2215, rmr64@georgetown.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parent Acceptance/Warmth during parent-child interactions (time frame: At baseline (when families are enrolled in the study)). The study lists 39 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06179576, which also lists 7 linked publications.
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 19 Aug 2025.