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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21HD097453-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Text4Father | Experimental | 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. |
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| Usual care | No Intervention | Usual care that is consistent with typical maternity care in involving expectant fathers. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Text4Father | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Overall Recruitment | Feasibility of recruitment will be measured as the number of fathers who were randomized and completed baseline procedures. | 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). | 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. | 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. | Follow-up (7 months) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 7 months (2 months post-birth) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arik V Marcell, MD, MPH | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34421016 | Background | 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. | |
| 29653255 | Background | 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. |
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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.
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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).
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Usual Care | Usual care that is consistent with typical maternity care in involving expectant fathers. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility of Overall Recruitment | Feasibility of recruitment will be measured as the number of fathers who were randomized and completed baseline procedures. | Posted | Count of Participants | Participants | At Baseline |
|
Up to 7 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Arik Marcell | Johns Hopkins Dept of Pediatrics / Division of Adolescent/Young Adult Medicine | 4432878946 | amarcell@jhu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 20, 2023 | Mar 10, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 25, 2020 | Apr 1, 2025 | ICF_001.pdf |
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2 groups will be enrolled and randomized to receipt or not receipt of the intervention.
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| 32409095 | Background | 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. |
| 30611921 | Background | 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. |
| BG001 | Usual Care | Usual care that is consistent with typical maternity care in involving expectant fathers. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Live with partner | Count of Participants | Participants |
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| First-time father | Count of Participants | Participants |
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| 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). | Posted | Count of Participants | Participants | Follow-up (7 months) |
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|
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| 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. | 12 individuals were lost to follow-up & 1 individual did not complete these items | Posted | Mean | Standard Deviation | score on a scale | Follow-up (7 months) |
|
|
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| 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. | 12 individuals were lost to follow-up & 1 individual did not complete these items | Posted | Mean | Standard Deviation | score on a scale | Follow-up (7 months) |
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| 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. | 12 intervention fathers were lost to follow-up; 10 usual care fathers were lost to follow-up. | Posted | Mean | Standard Deviation | score on a scale | 7 months (2 months post-birth) |
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| 0 |
| 53 |
| 0 |
| 53 |
| 0 |
| 53 |
| EG001 | Usual Care | Usual care that is consistent with typical maternity care in involving expectant fathers. | 0 | 44 | 0 | 44 | 0 | 44 |
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