N/A
N=60
Development, Feasibility and Acceptability of Fathers and Babies (FAB): A Pilot Study
Perinatal Depression · Postpartum Depression · Depression
Bottom Line
View on ClinicalTrials.gov: NCT03427528 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Jul 2022
Primary outcome: Primary: Change in Depressive Symptoms — 6.5; 9.7; 4.5; 8.4 score on a scale — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Fathers and Babies (FAB) (Behavioral); MB 1-on-1 plus TXT (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Northwestern University
- Primary completion
- Sep 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Depressive Symptoms |
6.5; 9.7; 4.5; 8.4; 3.6; 8.3 | <0.05 sig |
| PRIMARY Change in Anxiety |
4.1; 6.8; 3.2; 6.2; 2.8; 6.3 | >0.05 |
| PRIMARY Change in Perceived Stress |
14.9; 20.4; 12.6; 16.9; 10.9; 16.8 | <0.05 sig |
| SECONDARY Change in Social Support Effectiveness |
60.9; 48.9; 57.8; 51.4; 59.3; 52.2 | >0.05 |
| SECONDARY Instrumental Social Support Support Survey (Cyranowski et al., 2013). |
9; 4; 6; 8; 9; 9 | — |
| SECONDARY Emotional Support Support (Cyranowski et al., 2013) |
9; 7; 6; 9; 8; 5 | — |
Summary
During this project the investigators will develop and pilot test a companion intervention for fathers (Fathers and Babies-FAB), to supplement the Mothers and Babies Course (MB) that provides stress and mood management tools for home visiting clients. Focus groups with prior study participants, their male partners, and home visiting staff will be used to develop the FAB curriculum and protocol. FAB text messages aim to improve the mental health of the male partner and help him support his partner's mental health. Feasibility, acceptability, and outcome measures will be supplemented with assessments of fathers' mental health and partners' relationships. Participant assessments will be conducted at baseline, 3 and 6 months in this uncontrolled pilot study. The public health significance and innovation of this project is substantial. If the investigators are able to integrate MB-TXT and MB-DAD into home visiting programs and generate improved mental health outcomes for home visiting clients and their partners, the investigators will be prepared to replicate this intervention across home visiting programs nationally at a time when home visitation as a service delivery model for families with infants and young children is rapidly proliferating through federal funding.
Eligibility Criteria
Inclusion Criteria
English-speaking women >18 years old enrolled in home visiting programs who are in their 1st or 2nd or 3rd Trimester will be eligible for enrollment
Male partners of English-speaking women >18 years old enrolled in home visiting programs who are in their 1st or 2nd or 3rd Trimester will be eligible for enrollment
Note: Both parents/partners are required to participate in this study, not just one or the other.
Data sourced from ClinicalTrials.gov (NCT03427528). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.