FathersNCT06289101
text4FATHER R21: Social Media - Efficacy Trial
A study testing text4FATHER in people with Fathers and Mobile Health, run by Johns Hopkins University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fathers, Mobile Health, Nuclear Family
- What is being tested?
- text4FATHER
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2024to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged ≥18 years
- Live in the U.S.
- Speak English
- Mother gestational age at enrollment less than 25 weeks
- First-time father-to-be
- Willing/able to receive texts.
Who cannot join
- Individuals who are minors
- Do not speak English
- Unable to provide informed consent
- Not a first-time father
- Not willing/unable to receive texts
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Johns Hopkins University
Baltimore, Maryland, 21287
Arik V Marcell, MD, MPH, 443-287-8946, amarcell@jhu.edu
amarcell@jhu.edu
About this study
Official title: Adapting text4FATHER to Directly Link to First-time Expectant Fathers Using Social Media to Improve Infant and Family Health
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.
Read the detailed description
Father engagement in the prenatal and infant periods is associated with improved infant outcomes (e.g., physical, social and emotional health and development), and mother and father well-being. However, this key window of opportunity has been insufficiently leveraged to promote father engagement, especially, first-time fathers-to-be.
text4FATHER, a multi-modal text messaging program, is designed to increase first-time fathers' knowledge, self-efficacy, and behavioral engagement. text4FATHER sends texts twice-weekly to fathers with threaded content to support infant, partner, and father well-being including resource weblinks to support behavior change from mid-pregnancy through 2 months postnatally. Text content was developed using formative research and feedback from the target population, consensus building with experts, and an evidence-based review.
- Conditions
- Fathers, Mobile Health, Nuclear Family
- Being tested
- text4FATHER
- Keywords
- Fatherhood
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
text4FATHERBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: text4FATHER |
| Usual care | No intervention | Usual care that is consistent with typical maternity care in involving fathers-to-be. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Self-efficacy as assessed by the Parenting Sense of Competence Scale (PSOC)
Self-report measure with higher score indicating greater confidence in overall parenting skills. This measure is scaled with range from 1 (low) to 6 (high). Mean range 1-6.
Measured: Baseline and 7 months
Karitane Parenting Confidence Scale (KPCS)
Self-report measure with higher score indicating greater confidence in infant care behaviors. This measure is scaled with range from 0 (no, hardly ever) to 3 (yes, most times). Mean range 0-3.
Measured: Baseline and 7 months
Father Engagement Scale (FES)
Self-report measure with higher score indicating greater degree of father engagement in infant care activities. This measure is scaled with range from 0 (never) to 4 (every day or almost every day). Mean range 0-4.
Measured: Baseline and 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2024
- Study start10 Sep 2024
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for FathersStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 groups will be enrolled and randomized to receipt or not receipt of the intervention.
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Health Resources and Services Administration (HRSA)
- Responsible party
- Sponsor
- Investigators
- Arik Marcell, MD, MPH, Principal investigator, Johns Hopkins Dept of Pediatrics / Division of Adolescent/Young Adult Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06289101
- Sponsor's protocol ID
- IRB00422008
- Other IDs
- R21HD112617
- Status last verified
- Jul 2026
- First submitted
- 26 Feb 2024
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34421016Allport 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.
PubMed 29653255Allport-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.
PubMed 32409095Aqil 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.
PubMed 30611921
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapting text4FATHER to Directly Link to First-time Expectant Fathers Using Social Media to Improve Infant and Family Health
- ClinicalTrials.gov ID
- NCT06289101
- Acronym / sponsor ID
- IRB00422008
- Conditions
- Fathers, Mobile Health, Nuclear Family
- Keywords
- Fatherhood
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Health Resources and Services Administration (HRSA)
- Study start
- 10 Sep 2024 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 1 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Father engagement in the prenatal and infant periods is associated with improved infant outcomes (e.g., physical, social and emotional health and development), and mother and father well-being. However, this key window of opportunity has been insufficiently leveraged to promote father engagement, especially, first-time fathers-to-be.
text4FATHER, a multi-modal text messaging program, is designed to increase first-time fathers' knowledge, self-efficacy, and behavioral engagement. text4FATHER sends texts twice-weekly to fathers with threaded content to support infant, partner, and father well-being including resource weblinks to support behavior change from mid-pregnancy through 2 months postnatally. Text content was developed using formative research and feedback from the target population, consensus building with experts, and an evidence-based review.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2 groups will be enrolled and randomized to receipt or not receipt of the intervention.
| Arm | Type | Receives |
|---|---|---|
| text4FATHER | Experimental | Behavioral: text4FATHERReceipt 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 intervention | –Usual care that is consistent with typical maternity care in involving fathers-to-be. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged ≥18 years
- Live in the U.S.
- Speak English
- Mother gestational age at enrollment less than 25 weeks
- First-time father-to-be
Key exclusion criteria (6 listed)
- Individuals who are minors
- Do not speak English
- Unable to provide informed consent
- Not a first-time father
- Not willing/unable to receive texts
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| text4FATHERReceipt 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. | Behavioural | text4FATHER |
Primary outcome
Change in Self-efficacy as assessed by the Parenting Sense of Competence Scale (PSOC)
Time frame: Baseline and 7 months
Self-report measure with higher score indicating greater confidence in overall parenting skills. This measure is scaled with range from 1 (low) to 6 (high). Mean range 1-6.
Karitane Parenting Confidence Scale (KPCS)
Time frame: Baseline and 7 months
Self-report measure with higher score indicating greater confidence in infant care behaviors. This measure is scaled with range from 0 (no, hardly ever) to 3 (yes, most times). Mean range 0-3.
Father Engagement Scale (FES)
Time frame: Baseline and 7 months
Self-report measure with higher score indicating greater degree of father engagement in infant care activities. This measure is scaled with range from 0 (never) to 4 (every day or almost every day). Mean range 0-4.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Background: PubMed 34421016Marcell 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.
- Background: PubMed 29653255Allport 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.
- Background: PubMed 32409095Allport-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.
- Background: PubMed 30611921Aqil 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Arik Marcell, MD, MPH principal investigator
Johns Hopkins Dept of Pediatrics / Division of Adolescent/Young Adult Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing text4FATHER in people with Fathers and Mobile Health, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arik V Marcell, MD, MPH (4432878946, amarcell@jhu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Self-efficacy as assessed by the Parenting Sense of Competence Scale (PSOC) (time frame: Baseline and 7 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06289101, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.