Clinical trial NCT04101565: Text4Father Pilot Feasibility, Acceptability Study
Official title: Feasibility, Acceptability, & Preliminary Efficacy of Text4Father for Improving Infant & Family Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fathers
Mhealth
Mobile Health
Nuclear Family
Keywords: Fatherhood
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2019-09-24
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 groups will be enrolled and randomized to receipt or not receipt of the intervention.
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility of Overall Recruitment
timeFrame: At Baseline
measure: Feasibility of Overall Retention
timeFrame: Follow-up (7 months)
measure: Intervention Usability as Assessed by the Usability Score
timeFrame: Follow-up (7 months)
measure: Intervention Acceptability as Assessed by the Acceptability Score
timeFrame: Follow-up (7 months)
Secondary outcomes:
measure: Self-efficacy as Assessed by the Parenting Sense of Competence Scale (PSOC)
timeFrame: 7 months (2 months post-birth)
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Arik V Marcell, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.
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.