Text4Father Pilot Feasibility, Acceptability Study

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Fathers, Mhealth, Mobile Health, Nuclear Family

Intervention / Treatment
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* Behavioral: Text4Father


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 2 groups will be enrolled and randomized to receipt or not receipt of the intervention.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Text4Father<br>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<br>* 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.<br>|
| No Intervention: Usual care<br>Usual care that is consistent with typical maternity care in involving expectant fathers. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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) | 
| 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) | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fatherhood