text4FATHER R21: Social Media - Efficacy Trial

Johns Hopkins University

Status: Enrolling

Conditions: Mobile Health; Fathers; Nuclear Family

Treatments: Behavioral: text4FATHER

Study type: Interventional

Funder types: Other; Other U.S. Federal agency; NIH

Identifiers

NCT06289101

IRB00422008

R21HD112617 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups

text4FATHER

Experimental group

Description:

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.

Treatment:

Behavioral: text4FATHER

Usual care

No Intervention group

Description:

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