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EHS-CTB Hybrid for Parenting (CTB Trial)

N/A

Recruiting

Led By Rebecca Ryan, PhD

Research Sponsored by Georgetown University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

CTB Trial Summary

This trial is testing a new parenting program for low-income parents of infants. The program, called Connect to Baby (CTB), will be implemented in Washington, DC as part of the Early Head Start

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this intervention involves educational content rather than medical treatment, traditional side effects are not applicable. However, participants may experience changes in family dynamics or stress related to adapting new parenting practices.

CTB Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

CTB Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Coparenting Quality: competition

Coparenting Quality: cooperation

Coparenting Quality: displeasure in coparenting

+10 more

Secondary outcome measures

Child Language Development

Child language development

Child socioemotional development

+3 more

CTB Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: EHS-CTB HybridExperimental Treatment1 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 OnlyActive Control1 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.

0 / 2Eligibility criteria met

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Who is running the clinical trial?

Georgetown UniversityLead Sponsor

343 Previous Clinical Trials

136,302 Total Patients Enrolled

Rebecca Ryan, PhDPrincipal InvestigatorGeorgetown University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment process open for this medical study at present?

"Indeed, as per the information provided by clinicaltrials.gov, this study is actively seeking participants. The initial posting date was on August 1st, 2023 and it was most recently updated on December 19th, 2023."

Answered by AI

Are individuals above the age of 25 eligible to participate in this medical study?

"The eligibility requirements for this clinical trial indicate that individuals as young as 2 months old and up to the age of 40 are eligible for enrollment."

Answered by AI

What are the principal goals that this medical study aims to achieve?

"The primary focus of this clinical trial, evaluated over a period of 6 months, is to assess the level of Parent Acceptance/Warmth during interactions with their child. Secondary objectives include evaluating Child language development using the Individual Growth and Development Indicators (IGDI) Early Communication Indicator (ECI), which measures expressive communication in children aged 3 to 36 months through analysis of videotaped parent-infant play tasks. Additionally, the study aims to measure Parent self-efficacy using the Parental Sense of Competence Scale (with a total of 17 items rated on a scale from 1 to 6), as well as"

Answered by AI

Which group of individuals would be considered the most suitable candidates for participation in this clinical research study?

"To qualify for participation in this clinical trial, candidates must be between the ages of 2 months and 40 years old. Additionally, individuals with parental responsibilities are eligible to apply. The study aims to enroll approximately 200 participants."

Answered by AI

What is the current number of individuals under observation in this medical research study?

"Indeed, according to the details provided on clinicaltrials.gov, this study is actively seeking eligible participants. The trial was initially posted on August 1st, 2023 and last updated on December 19th, 2023. Recruitment aims to enroll a total of 200 individuals from one designated site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Connect to Baby: A Pilot Study of a Parenting and Coparenting Program

Rebecca Ryan 2023. "Connect to Baby: A Pilot Study of a Parenting and Coparenting Program". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06179576.