Text4Father Pilot Feasibility, Acceptability Study (Text4Father)

Feasibility, Acceptability, & Preliminary Efficacy of Text4Father for Improving Infant & Family Health

This study evaluates the feasibility, acceptability, and preliminary efficacy of Text4Father among first-time lower income fathers. Half of the participants will receive Text4Father - a text messaging educational program - from mid-pregnancy through 2 months of postnatal age, while the other half will receive usual care.

Study Overview

• Status: Completed
• Conditions: Mobile Health; Mhealth; Fathers; Nuclear Family
• Intervention / Treatment: Behavioral: Text4Father

Detailed Description

Text4Father, a multi-modal text messaging program, is designed to increase first-time lower income fathers' knowledge, self-efficacy, and behavioral engagement on infant care and parenting. Text4Father consists of 48-weeks of twice weekly texts written at a 5th grade reading level. Texts include resource links and instructions to support behavior change (e.g., videos, infographics), starting mid-pregnancy and continuing through 2 months of postnatal age. Text content was developed using formative research and feedback from the target population, consensus building with experts, and an evidence-based review.

Usual maternity care does not involve expectant fathers in education. Further, while father engagement is widely advocated, few public health and clinical approaches aim to engage expectant fathers during the prenatal period and first months after birth - a critical window of opportunity that has been insufficiently leveraged to promote father engagement when fathers describe being unsure of father role.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Stated willingness to comply with all study procedures and availability for the duration of the study
• Self-reported expectant father and pregnant partner (expectant mother)
• Aged ≥18 years
• In a romantic relationship and expect to continue to be in this relationship during the study period
• Able to speak English
• Lower socioeconomic status (SES) (e.g., high school/general education or vocational/trade school or less; or qualify for Medicaid/public insurance, WIC, SNAP, food stamps)
• Access to necessary resources for participating in a technology-based intervention (i.e., cell phone) and willing/able to receive/send texts

Exclusion Criteria:

• Individuals who are not able to provide informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
No Intervention: Usual care; Usual care that is consistent with typical maternity care in involving expectant fathers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of Overall Recruitment	Feasibility of recruitment will be measured as the number of fathers who were randomized and completed baseline procedures.	At Baseline
Feasibility of Overall Retention	Feasibility of retention will be assessed as the number of enrolled participants who complete 7-month follow-up survey (2-months of postnatal age).	Follow-up (7 months)
Intervention Usability as Assessed by the Usability Score	11 item self-report measure among participating intervention fathers with higher score indicating greater perceived usability of technology (text messaging program). This measure is scaled with range from 1 (low) to 4 (high). Mean of participant scale choice (1-4) is reported.	Follow-up (7 months)
Intervention Acceptability as Assessed by the Acceptability Score	An 9 item self-report measure among participating intervention fathers with higher score indicating greater perceived acceptability of technology (text messaging program). This measure is scaled with range from 1 (low) to 4 (high). Mean of participant scale choice (1-4) is reported.	Follow-up (7 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-efficacy as Assessed by the Parenting Sense of Competence Scale (PSOC)	17 item self-report measure with higher score indicating greater confidence in overall parenting skills to assess Parenting Sense of Competence (PSOC) at follow-up 7 months later (2 months post-birth). This measure is scaled with range from 1 (low) to 6 (high). Mean of participant scale choice (1-6) is reported.	7 months (2 months post-birth)

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Arik V Marcell, MD, MPH, Johns Hopkins University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 26, 2019
• Primary Completion (Actual): May 14, 2024
• Study Completion (Actual): May 31, 2024

Study Registration Dates

• First Submitted: September 23, 2019
• First Submitted That Met QC Criteria: September 23, 2019
• First Posted (Actual): September 24, 2019

Study Record Updates

• Last Update Posted (Actual): May 4, 2025
• Last Update Submitted That Met QC Criteria: April 17, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Fatherhood
• Other Study ID Numbers: IRB00226367; 1R21HD097453-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The final version of collected data will be made available within thirty (30) months after the end of the data collection. Data will be preserved and made accessible along with relevant documentation via the chosen repository (e.g., through open access (Open Inter-university Consortium for Political and Social Research (ICPSR)) if possible). Johns Hopkins University School of Medicine will review the disclosure protection of the de-identified datasets. If they conclude that the risk of disclosure is too great for public access, then ICPSR's Traditional Restricted Data or Physical Data Enclave will be used for some or all of the data, with restricted access solely to approved researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No