NCT04101565

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 24, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

December 26, 2019

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 14, 2024

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2024

Completed
11 months until next milestone

Results Posted

Study results publicly available

May 4, 2025

Completed
Last Updated

May 4, 2025

Status Verified

April 1, 2025

Enrollment Period

4.4 years

First QC Date

September 23, 2019

Results QC Date

March 11, 2025

Last Update Submit

April 17, 2025

Conditions

Keywords

Fatherhood

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

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.

Behavioral: Text4Father

Usual care

NO INTERVENTION

Usual care that is consistent with typical maternity care in involving expectant fathers.

Interventions

Text4FatherBEHAVIORAL

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.

Text4Father

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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: 34421016BACKGROUND
  • 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.

    PMID: 29653255BACKGROUND
  • 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.

    PMID: 32409095BACKGROUND
  • 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.

    PMID: 30611921BACKGROUND

Results Point of Contact

Title
Dr. Arik Marcell
Organization
Johns Hopkins Dept of Pediatrics / Division of Adolescent/Young Adult Medicine

Study Officials

  • Arik V Marcell, MD, MPH

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

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
Model Details: 2 groups will be enrolled and randomized to receipt or not receipt of the intervention.
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.

Locations