An interventional study of Text4Father in Fathers, Mhealth and Mobile Health, sponsored by Johns Hopkins University. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-04.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Prevention
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.
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.
Johns Hopkins University is the lead sponsor of 1,783 studies on the registry; 313 are open to participants now.
Of its 203 completed or terminated interventional studies of FDA-regulated products, 140 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Usual care that is consistent with typical maternity care in involving expectant fathers.
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.
Feasibility of Overall Recruitment
Feasibility of recruitment will be measured as the number of fathers who were randomized and completed baseline procedures.
Time frame: At Baseline
Feasibility of Overall Retention
Feasibility of retention will be assessed as the number of enrolled participants who complete 7-month follow-up survey (2-months of postnatal age).
Time frame: Follow-up (7 months)
Intervention Usability as Assessed by the Usability Score
11 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 4 (high). Mean of participant scale choice (1-4) is reported.
Time frame: Follow-up (7 months)
Intervention Acceptability as Assessed by the Acceptability Score
An 9 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 4 (high). Mean of participant scale choice (1-4) is reported.
Time frame: Follow-up (7 months)
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 Parenting Sense of Competence (PSOC) at follow-up 7 months later (2 months post-birth). This measure is scaled with range from 1 (low) to 6 (high). Mean of participant scale choice (1-6) is reported.
Time frame: 7 months (2 months post-birth)
| Milestone | text4FATHER | Usual Care |
|---|---|---|
| Started | 53 | 44 |
| Completed | 41 | 34 |
| Not completed | 12 | 10 |
Feasibility of recruitment will be measured as the number of fathers who were randomized and completed baseline procedures.
| Participants | text4FATHER | Usual Care |
|---|---|---|
| Feasibility of Overall Recruitment | 53 | 44 |
Feasibility of retention will be assessed as the number of enrolled participants who complete 7-month follow-up survey (2-months of postnatal age).
| Participants | text4FATHER | Usual Care |
|---|---|---|
| Feasibility of Overall Retention | 41 | 34 |
11 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 4 (high). Mean of participant scale choice (1-4) is reported.
| score on a scale | text4FATHER |
|---|---|
| Intervention Usability as Assessed by the Usability Score | 3.38 ± 0.39 |
An 9 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 4 (high). Mean of participant scale choice (1-4) is reported.
| score on a scale | text4FATHER |
|---|---|
| Intervention Acceptability as Assessed by the Acceptability Score | 3.33 ± 0.51 |
17 item self-report measure with higher score indicating greater confidence in overall parenting skills to assess Parenting Sense of Competence (PSOC) at follow-up 7 months later (2 months post-birth). This measure is scaled with range from 1 (low) to 6 (high). Mean of participant scale choice (1-6) is reported.
| score on a scale | text4FATHER | Usual Care |
|---|---|---|
| Self-efficacy as Assessed by the Parenting Sense of Competence Scale (PSOC) | 4.49 ± 0.79 | 4.49 ± 0.60 |
Collected over Up to 7 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| text4FATHER | 0/53 (0%) | 0/53 (0%) | 0/53 (0%) |
| Usual Care | 0/44 (0%) | 0/44 (0%) | 0/44 (0%) |
| Age, Customized(Participants) | text4FATHER | Usual Care | Total |
|---|---|---|---|
| 18-29 | 33 | 25 | 58 |
| 30 or older | 20 | 19 | 39 |
| Sex: Female, Male(Participants) | text4FATHER | Usual Care | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 53 | 44 | 97 |
| Race/Ethnicity, Customized(Participants) | text4FATHER | Usual Care | Total |
|---|---|---|---|
| non-Hispanic Black | 37 | 30 | 67 |
| non-Hispanic White | 12 | 11 | 23 |
| Hispanic | 3 | 2 | 5 |
| Other | 1 | 1 | 2 |
| Live with partner(Participants) | text4FATHER | Usual Care | Total |
|---|---|---|---|
| Count of participants | 43 | 39 | 82 |
| First-time father(Participants) | text4FATHER | Usual Care | Total |
|---|---|---|---|
| Count of participants | 28 | 16 | 44 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — The final version of collected data will be made available within thirty (30) months after the end of the data collection. Data will be preserved and made accessible along with relevant documentation via the chosen repository (e.g., through open access (Open Inter-university Consortium for Political and Social Research (ICPSR)) if possible). Johns Hopkins University School of Medicine will review the disclosure protection of the de-identified datasets. If they conclude that the risk of disclosure is too great for public access, then ICPSR's Traditional Restricted Data or Physical Data Enclave will be used for some or all of the data, with restricted access solely to approved researchers.
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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