text4FATHER R21: Social Media - Efficacy Trial

NCT ID: NCT06289101

Last Updated: 2025-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-10

Study Completion Date

2026-08-31

Brief Summary

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This project will be the first to examine the efficacy of a text messaging intervention designed to recruit first-time fathers-to-be using social media across the U.S. to become involved during pregnancy through two months of postnatal age to support infant, mother, and father well-being.

Detailed Description

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Father engagement in the prenatal and infant periods is associated with improved infant outcomes (e.g., physical, social and emotional health and development), and mother and father well-being. However, this key window of opportunity has been insufficiently leveraged to promote father engagement, especially, first-time fathers-to-be.

text4FATHER, a multi-modal text messaging program, is designed to increase first-time fathers' knowledge, self-efficacy, and behavioral engagement. text4FATHER sends texts twice-weekly to fathers with threaded content to support infant, partner, and father well-being including resource weblinks to support behavior change from mid-pregnancy through 2 months postnatally. Text content was developed using formative research and feedback from the target population, consensus building with experts, and an evidence-based review.

Conditions

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Fathers Mobile Health Nuclear Family

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

2 groups will be enrolled and randomized to receipt or not receipt of the intervention.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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text4FATHER

Receipt of twice-weekly texts that include resource links and instructions to support behavior change (e.g., videos, infographics) and start mid-pregnancy and continuing through 2 months of baby's age.

Group Type EXPERIMENTAL

text4FATHER

Intervention Type BEHAVIORAL

Receipt of twice-weekly texts that include resource links and instructions to support behavior change (e.g., videos, infographics) and start mid-pregnancy and continuing through 2 months of age.

Usual care

Usual care that is consistent with typical maternity care in involving fathers-to-be.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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text4FATHER

Receipt of twice-weekly texts that include resource links and instructions to support behavior change (e.g., videos, infographics) and start mid-pregnancy and continuing through 2 months of age.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Aged ≥18 years
* Live in the U.S.
* Speak English
* Mother gestational age at enrollment less than 25 weeks
* First-time father-to-be
* Willing/able to receive texts.

Exclusion Criteria

* Individuals who are minors
* Do not speak English
* Unable to provide informed consent
* Not a first-time father
* Not willing/unable to receive texts
* In the past 12 months, any safety concern reported between father-to-be and the mother-to-be, including report of any physical, emotional, sexual harm, threatening behaviors, police involvement, restraining or protective order
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role collaborator

Health Resources and Services Administration (HRSA)

FED

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Arik Marcell, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins Dept of Pediatrics / Division of Adolescent/Young Adult Medicine

Locations

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Johns Hopkins University

Baltimore, Maryland, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Arik V Marcell, MD, MPH

Role: CONTACT

4432878946

Facility Contacts

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Arik V Marcell, MD, MPH

Role: primary

443-287-8946

Role: backup

References

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Marcell AV, Johnson SB, Nelson T, Labrique AB, Eck KV, Skelton S, Aqil A, Gibson D. Protocol for the Feasibility, Acceptability, and Preliminary Efficacy Trial of text4FATHER for Improving Underserved Fathers' Involvement in Infant Care. J Health Care Poor Underserved. 2021;32(3):1110-1135. doi: 10.1353/hpu.2021.0117.

Reference Type BACKGROUND
PMID: 34421016 (View on PubMed)

Allport BS, Johnson S, Aqil A, Labrique AB, Nelson T, Kc A, Carabas Y, Marcell AV. Promoting Father Involvement for Child and Family Health. Acad Pediatr. 2018 Sep-Oct;18(7):746-753. doi: 10.1016/j.acap.2018.03.011. Epub 2018 Apr 10.

Reference Type BACKGROUND
PMID: 29653255 (View on PubMed)

Allport-Altillo BS, Aqil AR, Nelson T, Johnson SB, Labrique AB, Carabas Y, Marcell AV. Parents' Perspectives on Supporting Father Involvement in African American Families During Pregnancy and Early Infancy. J Natl Med Assoc. 2020 Aug;112(4):344-361. doi: 10.1016/j.jnma.2020.04.002. Epub 2020 May 11.

Reference Type BACKGROUND
PMID: 32409095 (View on PubMed)

Aqil A, Allport BS, Johnson SB, Nelson T, Labrique AB, Marcell AV. Content to share with expectant fathers: Views of professionals focused on father involvement. Midwifery. 2019 Mar;70:119-126. doi: 10.1016/j.midw.2018.12.018. Epub 2018 Dec 24.

Reference Type BACKGROUND
PMID: 30611921 (View on PubMed)

Other Identifiers

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R21HD112617

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00422008

Identifier Type: -

Identifier Source: org_study_id

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