Text Messaging for First-Time Fathers

Recruiting at 1 trial location

Overseen By Arik V Marcell, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Minors, Non-English speakers, Safety concerns, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

180 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates the effectiveness of a text messaging program, called text4FATHER, for first-time dads-to-be in supporting their family during and after pregnancy. Participants will receive text messages twice a week, offering links and tips to help them engage and support both mom and baby. The goal is to enhance the well-being of infants, mothers, and fathers. Ideal participants are first-time fathers in the U.S. who are comfortable receiving texts and have partners less than 25 weeks pregnant. As an unphased trial, this study provides a unique opportunity for first-time fathers to actively contribute to research that could improve family support systems.

Do I need to stop taking my current medications to join the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that this text messaging intervention is safe for first-time fathers?

Research shows that the text4FATHER program is being tested to determine its effectiveness for first-time dads. This program sends text messages with helpful links and instructions during pregnancy and after the baby is born.

As a text messaging program, it lacks the typical medical safety concerns associated with medications or surgeries. Previous studies on text-based programs have shown they are generally safe and well-received. Participants mainly need to be comfortable receiving regular messages. Prospective participants should ensure they are comfortable with receiving texts and using the provided resources. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the text4FATHER program because it offers a novel way to engage first-time fathers by using text messaging to support behavior change. Unlike traditional prenatal care that typically involves in-person classes or consultations, this program delivers twice-weekly texts with resource links, videos, and infographics directly to the father's phone. This convenient and accessible method aims to keep fathers informed and involved starting mid-pregnancy through their baby's early months, potentially leading to more supportive and engaged parenting.

What evidence suggests that the text4FATHER intervention is effective for supporting first-time fathers?

Research shows that involving fathers during pregnancy and early parenting leads to better outcomes for babies, mothers, and fathers. Studies have found that when fathers are more involved, babies tend to be healthier and develop better emotionally. This trial tests the text4FATHER program, which helps first-time dads get more involved by sending them useful text messages. Participants in the text4FATHER arm receive twice-weekly texts with resource links and instructions to support behavior change. Similar programs in the past have helped fathers feel more knowledgeable and confident. Early results suggest that these text-based programs positively affect family well-being. ^{1 3 4 6 7}

Who Is on the Research Team?

Arik Marcell, MD, MPH

Principal Investigator

Johns Hopkins Dept of Pediatrics / Division of Adolescent/Young Adult Medicine

Are You a Good Fit for This Trial?

This trial is for first-time fathers-to-be across the U.S. who want to be involved during pregnancy up until their child is two months old, aiming to support the well-being of the infant, mother, and father.

Inclusion Criteria

Willing/able to receive texts

Live in the U.S.

First-time father-to-be

Exclusion Criteria

Not a first-time father

In the past 12 months, any safety concern reported between father-to-be and the mother-to-be, including report of any physical, emotional, sexual harm, threatening behaviors, police involvement, restraining or protective order

I am unable to understand and give consent for treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive twice-weekly text messages with resource links and instructions to support behavior change from mid-pregnancy through 2 months postnatally

Approximately 6 months

Follow-up

Participants are monitored for changes in parenting confidence, self-efficacy, and father engagement

7 months

What Are the Treatments Tested in This Trial?

Interventions

• text4FATHER

Trial Overview

The study tests 'text4FATHER', a text messaging intervention designed to engage new dads. It's being evaluated for its effectiveness in increasing paternal involvement through messages sent via social media.

How Is the Trial Designed?

Group I: text4FATHER Experimental Treatment 1 Intervention

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.

Group II: Usual care Active Control 1 Intervention

Usual care that is consistent with typical maternity care in involving fathers-to-be.

text4FATHER is already approved in United States for the following indications:

Approved in United States as text4FATHER for:

• Supporting infant, mother, and father well-being during pregnancy and postnatal age

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Health Resources and Services Administration (HRSA)

Collaborator

Trials

88

Recruited

152,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Published Research Related to This Trial

The text4FATHER program aims to engage fathers, particularly from racial and ethnic minority backgrounds, during maternity care, which is crucial for improving infant outcomes.

This study will assess the feasibility, acceptability, and preliminary efficacy of the text4FATHER intervention from mid-pregnancy to two months after birth, highlighting the importance of involving fathers in infant care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol for the Feasibility, Acceptability, and Preliminary Efficacy Trial of text4FATHER for Improving Underserved Fathers' Involvement in Infant Care. Marcell, AV., Johnson, SB., Nelson, T., et al.[2022]

A study involving 418 healthcare professionals showed that providing a sample set of SMS messages (SMS4dads) significantly improved clinicians' understanding of the program, with 96% agreeing it helped them explain it better to parents.

After receiving the 'taster' messages, 88% of clinicians reported they were more likely to inform parents about the SMS4dads program, indicating that this approach may enhance the adoption of digital health interventions in supporting new fathers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Providing clinicians with 'how to' knowledge for technology-based innovation: Introducing the SMS4dads texts. Fletcher, R., Regan, C., StGeorge, J.[2023]

Text4baby effectively uses technology to provide health messages and promote healthy behaviors among pregnant women and new mothers, highlighting its potential as a valuable health intervention.

The authors emphasize the importance of conducting thorough evaluations of Text4baby's impact, particularly in diverse populations, to adapt and improve its use internationally, including in Russia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Text4baby in the United States and Russia: an opportunity for understanding how mHealth affects maternal and child health. Parker, RM., Dmitrieva, E., Frolov, S., et al.[2022]

The Text4Dad text messaging intervention successfully engaged fathers in home visiting programs, with Fatherhood Community Health Workers (F-CHWs) effectively enrolling fathers and finding the content acceptable for their needs.

Despite the usability of the Text4Dad platform, F-CHWs faced challenges accessing it during home visits, which contributed to a lower than expected response rate from fathers to the text messages.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing a Text Messaging Intervention to Engage Fathers in Home Visiting. Lee, JY., Lee, SJ.[2023]

Text4baby is a pioneering free text messaging service in the U.S. designed to provide essential health information to pregnant women and new mothers, successfully enrolling over 320,000 participants from its launch in 2010 to March 2012.

The rapid enrollment and widespread promotion of Text4baby highlight the effectiveness of public-private partnerships in improving maternal and infant health through accessible communication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Text4baby: development and implementation of a national text messaging health information service. Whittaker, R., Matoff-Stepp, S., Meehan, J., et al.[2021]

The SMS4dads program, a text messaging intervention designed for fathers, aims to reduce self-reported depression, anxiety, and stress during the perinatal period by providing targeted support and information, with 800 fathers participating in the study.

This study will evaluate the effectiveness of SMS4dads compared to a control group receiving generic health messages, assessing improvements in mental health and parenting confidence over a 24-week period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Text-Based Program Addressing the Mental Health of Soon-to-be and New Fathers (SMS4dads): Protocol for a Randomized Controlled Trial. Fletcher, R., May, C., Attia, J., et al.[2020]

In a study of 468 pregnant and postpartum women, those with higher education levels and better household income were more successful in enrolling in the text4baby program, highlighting the importance of socioeconomic factors in access to health resources.

Over 90% of participants reported receiving and reading text4baby messages regularly, indicating high engagement with the program, but younger women and those with lower education and health literacy faced challenges in message reception, suggesting a need for targeted support in these groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Text4baby program: an opportunity to reach underserved pregnant and postpartum women? Gazmararian, JA., Elon, L., Yang, B., et al.[2021]

Text4baby, a free text-message program for pregnancy, delivered 1399 messages, focusing significantly more on topics like Postpartum Planning and Seeking Care compared to popular pregnancy smartphone apps.

In contrast, Text4baby provided less information on Normal Pregnancy Symptoms, and none of the messaging programs included content on postpartum contraception, suggesting areas for improvement in the program's content.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Social media messaging in pregnancy: comparing content of Text4baby to content of free smart phone applications of pregnancy. Lewkowitz, AK., O'Donnell, BE., Nakagawa, S., et al.[2015]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06289101

text4FATHER R21: Social Media - Efficacy Trial

This project will be the first to examine the efficacy of a text messaging intervention designed to recruit first-time fathers-to-be using social media across ...

2.

centerwatch.com

centerwatch.com/clinical-trials/listings/NCT06289101/text4father-r21-social-media-efficacy-trial

text4FATHER R21: Social Media - Efficacy Trial

This project will be the first to examine the efficacy of a text messaging intervention designed to recruit first-time fathers-to-be using ...

3.

clinicaltrial.be

clinicaltrial.be/en/details/427508?only_active=0&only_eligible=0&only_recruiting=0&per_page=20

text4FATHER R21: Social Media - Efficacy Trial

Father engagement in the prenatal and infant periods is associated with improved infant outcomes (e.g., physical, social and emotional ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8938706/

Protocol for the feasibility, acceptability, and preliminary ...

This study protocol describes the text4FATHER's feasibility, acceptability, and preliminary efficacy trial from mid-pregnancy through 2 months of postnatal age.

5.

popcenter.jhu.edu

popcenter.jhu.edu/projects/feasibility-acceptability-and-preliminary-efficacy-of-text4father-for-improving-infant-and-family-health/

Feasibility acceptability and preliminary efficacy of ...

Text4Father, a multi-modal text messaging program, is designed to increase first-time lower SES fathers' knowledge, self-efficacy, and behavioral engagement on ...

6.

trialx.com

trialx.com/clinical-trials/listings/302236/text4father-r21-social-media-efficacy-trial/

text4FATHER R21: Social Media - Efficacy Trial

This project will be the first to examine the efficacy of a text messaging intervention designed to recruit first-time fathers-to-be using social media across ...

7.

krieger.jhu.edu

krieger.jhu.edu/publichealth/bulletin-board/undergraduate-research-opportunity-text4father-study/

Undergrad Research Opportunity: text4FATHER Study

text4FATHER is a mobile health (mHealth) program developed to support first-time expectant fathers, especially those with lower education levels ...