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

Trial Summary

What is the purpose of this 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 the U.S. to become involved during pregnancy through two months of postnatal age to support infant, mother, and father well-being.

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 data supports the effectiveness of the treatment text4FATHER?

Research shows that text messaging programs like text4FATHER can effectively engage fathers, especially those who are underserved, in infant care and support. Similar programs, such as Text4baby, have been successful in reaching underserved populations and promoting healthy behaviors through regular text message communication. ^{1 2 3 4 5}

Is the text messaging intervention for first-time fathers safe?

The text messaging interventions like Text4baby and Text4Dad have been used to provide health information to pregnant women, new mothers, and fathers without any reported safety issues. These programs have been implemented successfully in various settings, suggesting they are generally safe for human use. ^{1 2 3 6 7}

How is the text4FATHER treatment different from other treatments for engaging first-time fathers?

Text4FATHER is unique because it uses text messaging to engage first-time fathers in infant care, focusing on underserved and minority groups, which is not commonly addressed by other treatments. This approach is inspired by the successful Text4baby program, which provides health information to pregnant women and new mothers through text messages. ^{1 2 3 7 8}

Research Team

Arik Marcell, MD, MPH

Principal Investigator

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

Eligibility Criteria

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.

Speak English

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 under the legal adult age.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Text4baby program: an opportunity to reach underserved pregnant and postpartum women? [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Protocol for the Feasibility, Acceptability, and Preliminary Efficacy Trial of text4FATHER for Improving Underserved Fathers' Involvement in Infant Care. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Implementing a Text Messaging Intervention to Engage Fathers in Home Visiting. [2023]

4. Australia pubmed.ncbi.nlm.nih.gov

Providing clinicians with 'how to' knowledge for technology-based innovation: Introducing the SMS4dads texts. [2023]

5. Canada 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. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Text4baby in the United States and Russia: an opportunity for understanding how mHealth affects maternal and child health. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Text4baby: development and implementation of a national text messaging health information service. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Social media messaging in pregnancy: comparing content of Text4baby to content of free smart phone applications of pregnancy. [2015]