Text4Father Pilot Feasibility, Acceptability Study

Mobile Health Clinical Trial

— Text4Father  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04101565
• Other study ID #: IRB00226367
• Secondary ID: 1R21HD097453-01A
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 26, 2019
• Est. completion date: July 31, 2024

Study information

• Verified date: May 2024
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 97
• Est. completion date: July 31, 2024
• Est. primary completion date: May 14, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fathers
• Mhealth
• 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	Feasibility of overall recruitment	Feasibility of recruitment will be measured as the Proportion of eligible fathers who consent to study participation and recruitment by resident status.	At Baseline
Primary	Feasibility of overall retention	Feasibility of retention will be assessed as the Proportion of enrolled participants who complete 7-month follow-up survey (2-months of postnatal age).	Follow-up (7 months)
Primary	Intervention usability as assessed by the Usability score	12 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 5 (high) with a minimum score of 12 and a maximum total score of 60.	Follow-up (7 months)
Primary	Intervention acceptability as assessed by the acceptability score	An 8 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 5 (high) with a minimum score of 8 and a maximum of 40.	Follow-up (7 months)
Secondary	Change in 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 for mean change on Parenting Sense of Competence (PSOC) from baseline (during pregnancy) to follow-up (2 months post-birth). This measure is scaled with range from 1 (low) to 6 (high) with a total maximum score of 102 and a minimum of 17	baseline and 7 months