Clinical trial NCT06289101: text4FATHER R21: Social Media - Efficacy Trial
Official title: Adapting text4FATHER to Directly Link to First-time Expectant Fathers Using Social Media to Improve Infant and Family Health
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fathers
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)
name: Health Resources and Services Administration (HRSA)
First posted: 2024-03-01
Enrollment: 180
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 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Self-efficacy as assessed by the Parenting Sense of Competence Scale (PSOC)
timeFrame: Baseline and 7 months
measure: Karitane Parenting Confidence Scale (KPCS)
timeFrame: Baseline and 7 months
measure: Father Engagement Scale (FES)
timeFrame: Baseline and 7 months
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins Dept of Pediatrics / Division of Adolescent/Young Adult Medicine
name: Arik 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.