Clinical trial NCT06179576: Connect to Baby: A Pilot Study of a Parenting and Coparenting Program
Official title: Connect to Baby: A Pilot Study of a Parenting and Coparenting Program for New Parents
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parenting
Keywords: Parent Education
Lead sponsor: Georgetown University
Sponsor class: OTHER
First posted: 2023-12-22
Enrollment: 200
Sex: ALL
Minimum age (years): 2
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Parent Acceptance/Warmth during parent-child interactions
timeFrame: At baseline (when families are enrolled in the study)
measure: Parent Acceptance/Warmth during parent-child interactions
timeFrame: 3 months
measure: Parent Acceptance/Warmth during parent-child interactions
timeFrame: 6 months
measure: Parent Descriptive Language during parent-child interactions
timeFrame: At baselined (when families enroll in the study)
measure: Parent Descriptive Language during parent-child interactions
timeFrame: 3 months
measure: Parent Descriptive Language during parent-child interactions
timeFrame: 6 months
measure: Parent Follows child's lead during parent-child interactions
timeFrame: At baseline (when families enroll in the study)
measure: Parent Follows child's lead during parent-child interactions
timeFrame: 3 months
measure: Parent Follows child's lead during parent-child interactions
timeFrame: 6 months
measure: Parent Extends Child's Focus during parent-child interactions
timeFrame: At baseline (when families enroll in the study
measure: Parent Extends Child's Focus during parent-child interactions
timeFrame: 3 months
measure: Parent Extends Child's Focus during parent-child interactions
timeFrame: 6 months
measure: Parent restricts child during parent-child interactions
timeFrame: At baseline (when families enroll in the study)
measure: Parent restricts child during parent-child interactions
timeFrame: 3 months
measure: Parent restricts child during parent-child interactions
timeFrame: 6 months
measure: Parent criticizes child during parent-child interactions
timeFrame: At baseline (when families enroll in the study)
measure: Parent criticizes child during parent-child interactions
timeFrame: 3 months
measure: Parent criticizes child during parent-child interactions
timeFrame: 6 months
measure: Coparenting Quality:mother-father pleasure in coparenting
timeFrame: At baseline (when families enroll in the study)
measure: Coparenting Quality:mother-father pleasure in coparenting
timeFrame: 3 months
measure: Coparenting Quality:mother-father pleasure in coparenting
timeFrame: 6 months
measure: Coparenting Quality: displeasure in coparenting
timeFrame: At baseline (when families enroll in the study)
measure: Coparenting Quality: displeasure in coparenting
timeFrame: 3 months
measure: Coparenting Quality: displeasure in coparenting
timeFrame: 6 months
measure: Coparenting Quality: interactiveness
timeFrame: at baseline (when families enroll in the study)
measure: Coparenting Quality: interactiveness
timeFrame: 3 months
measure: Coparenting Quality: interactiveness
timeFrame: 6 months
measure: Coparenting Quality: cooperation
timeFrame: At baseline (when families enroll in the study)
measure: Coparenting Quality: cooperation
timeFrame: 3 months
measure: Coparenting Quality: cooperation
timeFrame: 6 months
measure: Coparenting Quality: competition
timeFrame: At baseline (when families enroll in the study)
measure: Coparenting Quality: competition
timeFrame: 3 months
measure: Coparenting Quality: competition
timeFrame: 6 months
measure: Coparenting Relationship Scale
timeFrame: At baseline (when families enroll in the study)
measure: Coparenting Relationship Scale
timeFrame: 3 months
measure: Coparenting Relationship Scale
timeFrame: 6 months
measure: Father Engagement Scale
timeFrame: At baseline (when families enroll in the study)
measure: Father Engagement Scale
timeFrame: 3 months
measure: Father Engagement Scale
timeFrame: 6 months
Secondary outcomes:
measure: Parent mental health
timeFrame: At baseline (when families enroll in the study)
measure: Parent mental health
timeFrame: 3 months
measure: Parent mental health
timeFrame: 6 months
measure: Parent self efficacy
timeFrame: at baseline (when families enroll in the study)
measure: Parent self efficacy
timeFrame: 3 months
measure: Parent self efficacy
timeFrame: 6 months
measure: Child language development
timeFrame: At baseline (when families enroll in the study)
measure: Child language development
timeFrame: 3 months
measure: Child language development
timeFrame: 6 months
measure: Child socioemotional development
timeFrame: at baseline (when families enroll in the study)
measure: Child socioemotional development
timeFrame: 3 months
measure: Child socioemotional development
timeFrame: 6 months
measure: Parent Generalized Anxiety Scale
timeFrame: At baseline (when families enroll in the study)
measure: Parent Generalized Anxiety Scale
timeFrame: 3 months
measure: Parent Generalized Anxiety Scale
timeFrame: 6 months
measure: Child Language Development
timeFrame: 3 months
measure: Child Language Development
timeFrame: 6 months
Other outcomes:
Locations:
city: Washington
country: United States
facility: Child Development and Social Policy Lab
state: District of Columbia
Study officials:
affiliation: Georgetown University
name: Rebecca Ryan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
citation: 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
citation: 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.
citation: 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.
citation: 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.