text4FATHER R21: Social Media - Efficacy Trial

Mobile Health Clinical Trial

Official title:

Adapting text4FATHER to Directly Link to First-time Expectant Fathers Using Social Media to Improve Infant and Family Health

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06289101
• Other study ID #: IRB00422008
• Secondary ID: R21HD112617
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: July 2025

Study information

• Verified date: May 2024
• Source: Johns Hopkins University
• Contact: Arik V Marcell, MD, MPH
• Phone: 4432878946
• Email: amarcell[@]jhu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Est. completion date: July 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fathers
• Mobile Health
• Nuclear Family

Intervention

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.

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Self-efficacy as assessed by the Parenting Sense of Competence Scale (PSOC)	Self-report measure with higher score indicating greater confidence in overall parenting skills. This measure is scaled with range from 1 (low) to 6 (high). Mean range 1-6.	Baseline and 7 months
Primary	Karitane Parenting Confidence Scale (KPCS)	Self-report measure with higher score indicating greater confidence in infant care behaviors. This measure is scaled with range from 0 (no, hardly ever) to 3 (yes, most times). Mean range 0-3.	Baseline and 7 months
Primary	Fathering Self-Efficacy Scale (FSES)	Self-report measure with higher score indicating greater confidence in the father role. This measure is scaled with range from 1 (completely disagree) to 9 (completely agree). Mean range 1-9.	Baseline and 7 months
Primary	Father Engagement Scale (FES)	Self-report measure with higher score indicating greater degree of father engagement in infant care activities. This measure is scaled with range from 0 (never) to 4 (every day or almost every day). Mean range 0-4.	Baseline and 7 months
Primary	The Co-Parenting Relationship Scale	Self-report measure with higher score indicating greater degree of coparenting agreement and support. This measure is scaled with range from 0 (not true of us) to 6 (very true of us). Mean range 0-6.	Baseline and 7 months