Trial Outcomes & Findings for Text4Father Pilot Feasibility, Acceptability Study (NCT NCT04101565)

Results Overview

Feasibility of recruitment will be measured as the number of fathers who were randomized and completed baseline procedures.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

120 participants

Primary outcome timeframe

At Baseline

Results posted on

2025-05-04

Participant Flow

120 participants completed consent procedures, and a total of 97 completed baseline study survey procedures and then were randomized (23 participants did not complete the baseline survey study activity, and were thus not randomized).

Participant milestones

Participant milestones
Measure	text4FATHER 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. text4FATHER: 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.	Usual Care Usual care that is consistent with typical maternity care in involving expectant fathers.
Overall Study STARTED	53	44
Overall Study COMPLETED	41	34
Overall Study NOT COMPLETED	12	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Text4Father Pilot Feasibility, Acceptability Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	text4FATHER n=53 Participants 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. text4FATHER: 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.	Usual Care n=44 Participants Usual care that is consistent with typical maternity care in involving expectant fathers.	Total n=97 Participants Total of all reporting groups
Age, Customized 18-29	33 Participants n=5 Participants	25 Participants n=7 Participants	58 Participants n=5 Participants
Age, Customized 30 or older	20 Participants n=5 Participants	19 Participants n=7 Participants	39 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	53 Participants n=5 Participants	44 Participants n=7 Participants	97 Participants n=5 Participants
Race/Ethnicity, Customized non-Hispanic Black	37 Participants n=5 Participants	30 Participants n=7 Participants	67 Participants n=5 Participants
Race/Ethnicity, Customized non-Hispanic White	12 Participants n=5 Participants	11 Participants n=7 Participants	23 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Live with partner	43 Participants n=5 Participants	39 Participants n=7 Participants	82 Participants n=5 Participants
First-time father	28 Participants n=5 Participants	16 Participants n=7 Participants	44 Participants n=5 Participants

PRIMARY outcome

Timeframe: At Baseline

Feasibility of recruitment will be measured as the number of fathers who were randomized and completed baseline procedures.

Outcome measures

Outcome measures
Measure	text4FATHER n=53 Participants 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. text4FATHER: 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.	Usual Care n=44 Participants Usual care that is consistent with typical maternity care in involving expectant fathers.
Feasibility of Overall Recruitment	53 Participants	44 Participants

PRIMARY outcome

Timeframe: Follow-up (7 months)

Feasibility of retention will be assessed as the number of enrolled participants who complete 7-month follow-up survey (2-months of postnatal age).

Outcome measures

Outcome measures
Measure	text4FATHER n=53 Participants 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. text4FATHER: 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.	Usual Care n=44 Participants Usual care that is consistent with typical maternity care in involving expectant fathers.
Feasibility of Overall Retention	41 Participants	34 Participants

PRIMARY outcome

Timeframe: Follow-up (7 months)

Population: 12 individuals were lost to follow-up \& 1 individual did not complete these items

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.

Outcome measures

Outcome measures
Measure	text4FATHER n=40 Participants 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. text4FATHER: 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.	Usual Care Usual care that is consistent with typical maternity care in involving expectant fathers.
Intervention Usability as Assessed by the Usability Score	3.38 score on a scale Standard Deviation 0.39	—

PRIMARY outcome

Timeframe: Follow-up (7 months)

Population: 12 individuals were lost to follow-up \& 1 individual did not complete these items

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.

Outcome measures

Outcome measures
Measure	text4FATHER n=40 Participants 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. text4FATHER: 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.	Usual Care Usual care that is consistent with typical maternity care in involving expectant fathers.
Intervention Acceptability as Assessed by the Acceptability Score	3.33 score on a scale Standard Deviation 0.51	—

SECONDARY outcome

Timeframe: 7 months (2 months post-birth)

Population: 12 intervention fathers were lost to follow-up; 10 usual care fathers were lost to follow-up.

17 item self-report measure with higher score indicating greater confidence in overall parenting skills to assess Parenting Sense of Competence (PSOC) at follow-up 7 months later (2 months post-birth). This measure is scaled with range from 1 (low) to 6 (high). Mean of participant scale choice (1-6) is reported.

Outcome measures

Outcome measures
Measure	text4FATHER n=41 Participants 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. text4FATHER: 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.	Usual Care n=34 Participants Usual care that is consistent with typical maternity care in involving expectant fathers.
Self-efficacy as Assessed by the Parenting Sense of Competence Scale (PSOC)	4.49 score on a scale Standard Deviation 0.79	4.49 score on a scale Standard Deviation 0.60

Adverse Events

text4FATHER

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Arik Marcell

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

Phone: 4432878946

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place