Fathers, Mhealth, Mobile Health, Nuclear Family
Conditions
Keywords
Fatherhood
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.
Interventions
BEHAVIORALText4Father
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.
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
2 groups will be enrolled and randomized to receipt or not receipt of the intervention.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Overall Recruitment | At Baseline | Feasibility of recruitment will be measured as the number of fathers who were randomized and completed baseline procedures. |
| Feasibility of Overall Retention | Follow-up (7 months) | Feasibility of retention will be assessed as the number of enrolled participants who complete 7-month follow-up survey (2-months of postnatal age). |
| Intervention Usability as Assessed by the Usability Score | Follow-up (7 months) | 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. |
| Intervention Acceptability as Assessed by the Acceptability Score | Follow-up (7 months) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-efficacy as Assessed by the Parenting Sense of Competence Scale (PSOC) | 7 months (2 months post-birth) | 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. |
Countries
United States
Participant flow
Pre-assignment details
120 participants completed consent procedures, and a total of 97 completed baseline study survey procedures and then were randomized (23 participants did not complete the baseline survey study activity, and were thus not randomized).
Participants by arm
| Arm | Count |
|---|---|
| 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 baby's age.
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. | 53 |
| Usual Care Usual care that is consistent with typical maternity care in involving expectant fathers. | 44 |
| Total | 97 |
Baseline characteristics
| Characteristic | text4FATHER | Usual Care | Total |
|---|---|---|---|
| Age, Customized 18-29 | 33 Participants | 25 Participants | 58 Participants |
| Age, Customized 30 or older | 20 Participants | 19 Participants | 39 Participants |
| First-time father | 28 Participants | 16 Participants | 44 Participants |
| Live with partner | 43 Participants | 39 Participants | 82 Participants |
| Race/Ethnicity, Customized Hispanic | 3 Participants | 2 Participants | 5 Participants |
| Race/Ethnicity, Customized non-Hispanic Black | 37 Participants | 30 Participants | 67 Participants |
| Race/Ethnicity, Customized non-Hispanic White | 12 Participants | 11 Participants | 23 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 53 Participants | 44 Participants | 97 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 53 | 0 / 44 |
| other Total, other adverse events | 0 / 53 | 0 / 44 |
| serious Total, serious adverse events | 0 / 53 | 0 / 44 |
Outcome results
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| text4FATHER | Feasibility of Overall Recruitment | 53 Participants |
| Usual Care | Feasibility of Overall Recruitment | 44 Participants |
Primary
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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| text4FATHER | Feasibility of Overall Retention | 41 Participants |
| Usual Care | Feasibility of Overall Retention | 34 Participants |
Primary
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)
Population: 12 individuals were lost to follow-up \& 1 individual did not complete these items
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| text4FATHER | Intervention Acceptability as Assessed by the Acceptability Score | 3.33 score on a scale | Standard Deviation 0.51 |
Primary
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)
Population: 12 individuals were lost to follow-up \& 1 individual did not complete these items
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| text4FATHER | Intervention Usability as Assessed by the Usability Score | 3.38 score on a scale | Standard Deviation 0.39 |
Secondary
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)
Population: 12 intervention fathers were lost to follow-up; 10 usual care fathers were lost to follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| text4FATHER | Self-efficacy as Assessed by the Parenting Sense of Competence Scale (PSOC) | 4.49 score on a scale | Standard Deviation 0.79 |
| Usual Care | Self-efficacy as Assessed by the Parenting Sense of Competence Scale (PSOC) | 4.49 score on a scale | Standard Deviation 0.6 |