Text4Father Pilot Feasibility, Acceptability Study
Text4Father
Feasibility, Acceptability, & Preliminary Efficacy of Text4Father for Improving Infant & Family Health
2 other identifiers
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 23, 2019
CompletedFirst Posted
Study publicly available on registry
September 24, 2019
CompletedStudy Start
First participant enrolled
December 26, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 14, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2024
CompletedResults Posted
Study results publicly available
May 4, 2025
CompletedMay 4, 2025
April 1, 2025
4.4 years
September 23, 2019
March 11, 2025
April 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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)
Secondary Outcomes (1)
Self-efficacy as Assessed by the Parenting Sense of Competence Scale (PSOC)
7 months (2 months post-birth)
Study Arms (2)
Text4Father
EXPERIMENTALReceipt 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.
Usual care
NO INTERVENTIONUsual care that is consistent with typical maternity care in involving expectant fathers.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Individuals who are not able to provide informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
Related Publications (4)
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.
PMID: 34421016BACKGROUNDAllport 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.
PMID: 29653255BACKGROUNDAllport-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.
PMID: 32409095BACKGROUNDAqil 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.
PMID: 30611921BACKGROUND
Results Point of Contact
- Title
- Dr. Arik Marcell
- Organization
- Johns Hopkins Dept of Pediatrics / Division of Adolescent/Young Adult Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Arik V Marcell, MD, MPH
Johns Hopkins University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 23, 2019
First Posted
September 24, 2019
Study Start
December 26, 2019
Primary Completion
May 14, 2024
Study Completion
May 31, 2024
Last Updated
May 4, 2025
Results First Posted
May 4, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share
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.