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Development, Feasibility and Acceptability of Fathers and Babies (FAB): A Pilot Study

Sponsor
Northwestern University (Other)
Overall Status
Completed
CT.gov ID
NCT03427528
Collaborator
National Institute on Minority Health and Health Disparities (NIMHD) (NIH)
60
Enrollment
1
Location
2
Arms
30.6
Actual Duration (Months)
2
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Fathers and Babies (FAB)
  • Behavioral: MB 1-on-1 plus TXT
 N/A

Detailed Description

Enhancements to Mothers and Babies are warranted to address the mental health of both parents, via the home visitation service delivery model where many of the most at-risk families enter into provider-client relationships during their child's infancy and early childhood.

Previous postpartum depression preventive interventions-including MB-have neglected to intervene with partners of pregnant women, despite the growing recognition that paternal depression also exerts influence on children's social-emotional development and occurs in a similar time-frame. Thus, in an otherwise successful intervention, these limitations-mixed success in improving hypothesized intervention mechanisms and limited engagement of fathers-may mitigate intervention efficacy. Paternal depression is hypothesized to mediate the relationship between MB modules and maternal mental health outcomes.

This study addresses this limitation. The investigators will collaborate with 10-12 home visiting (HV) programs serving primarily low-income families. The investigators will recruit 24 mother-father dyads for an uncontrolled pilot in which mothers will receive MB-TXT and fathers will receive FAB, a pilot curriculum developed using existing materials and data collected via qualitative research with home visiting clients, their partners, and home visiting staff.

Aim 1. To develop and determine the feasibility and acceptability of a) conducting the MB-DAD intervention protocol and b) assessing paternal and dyadic outcomes across two home visiting programs. Focus groups with prior trial participants, their male partners, and home visiting staff will generate information on a) intervention content, b) frequency of contact, and c) relationship to MB materials received by their partner.

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
We will conduct an uncontrolled pilot study examining acceptability and feasibility of the Fathers and Babies (FAB) curriculum.We will conduct an uncontrolled pilot study examining acceptability and feasibility of the Fathers and Babies (FAB) curriculum.
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Integrating Text Messages Into the Mothers and Babies Course to Address Depression in Low-Income Women and Their Partners
Actual Study Start Date :
Feb 15, 2018
Actual Primary Completion Date :
Sep 4, 2020
Actual Study Completion Date :
Sep 4, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: FAB Pilot Study (Father/Male Participants)

Fathers (male partners) received Fathers and Babies (FAB). FAB is a 12-session intervention with content that mirrors content found in MB, but was father-centric. The initial FAB session was delivered in person or by phone by the home visitor working with the mother, and lasted 30 min on average. Subsequent sessions were delivered, in-person, via text message with embedded links to online content, or a mix of both in-person and text messages, depending on the preference and availability of the father. Fathers received three to six text messages per FAB session.

Behavioral: Fathers and Babies (FAB)
The initial FAB session was delivered in person or by phone by the home visitor working with the mother, and lasted 30 min on average. Subsequent sessions were delivered, in-person, via text message with embedded links to online content, or a mix of both in-person and text messages, depending on the preference and availability of the father. Fathers received three to six text messages per FAB session.
Experimental: MB 1-on-1 Plus TEXT (Mother/Female Participants)

Home visiting clients received the Mothers and Babies with -Text Messages intervention in person during regular scheduled home visits (i.e., MB 1-on-1 plus MB-TXT) while her partner received Fathers and Babies in parallel. MB 1-on-1 is 12-sessions and is a postpartum depression preventive intervention. MB includes an introductory module followed by three cognitive-behavioral therapy modules: (1) pleasant activities, (2) thoughts, and (3) contact with others. After each in person session home visiting clients receive three messages to reinforce skill practice and remind them about their personal projects.

Behavioral: MB 1-on-1 plus TXT
Home visiting clients received the Mothers and Babies with -Text Messages intervention in person during regular scheduled home visits (i.e., MB 1-on-1 plus MB-TXT). After each in person session home visiting clients receive three messages to reinforce skill practice and remind them about their personal projects.

Outcome Measures

Primary Outcome Measures

  1. Change in Depressive Symptoms [Baseline and Post Intervention at 3 and 6 months]

    Beck Depression Inventory-II (BDI-II) (Beck et al., 1988). The BDI-II was used to assess severity of depressive symptoms consistent with DSM-IV symptom criteria. The BDI-II is a 21-item survey, each item asks respondents to indicate on a scale ranging from 0 to 3 the extent to which they endorse different symptoms of depression over the past two weeks with higher scores indicating greater depression severity, with the highest score of 63. 0-10-considered normal 11-16 Mild mood disturbance 17-20 Borderline clinical depression 21-30 Moderate depression 31-40 Severe depression Over 40 Extreme depression.

  2. Change in Anxiety [Baseline and Post Intervention at 3 and 6 months]

    Generalized Anxiety Disorder 7-item Scale (GAD-7) (Spitzer et al., 2006). The GAD-7 is a 7-item survey, each item asks respondents to indicate on a 4-point scale the extent to which they endorse different symptoms of anxiety over the past two weeks with higher scores indicating greater anxiety symptoms. The highest score is 21. Score 0-4: Minimal Anxiety Score 5-9: Mild Anxiety Score 10-14: Moderate Anxiety Score greater than 15: Severe Anxiety

  3. Change in Perceived Stress [Baseline and Post Intervention at 3 and 6 months]

    Perceived Stress Scale 10-item Scale (PSS-10) (Cohen & Williamson, 1988). The PSS-10 is a 10-item survey that asks respondents to indicate on a 5-point scale the extent to which they appraised certain situations as stressful over the past month, with higher scores indicating greater perceived stress. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress. 0-13 are considered low stress Scores ranging from 14-26 are considered moderate stress Scores ranging from 27-40 are considered high perceived stress

Secondary Outcome Measures

  1. Change in Social Support Effectiveness [Baseline and Post Intervention at 3 and 6 months]

    Social Support Effectiveness Questionnaire (SSE-Q) (Rini et al., 2011). The SSE-Q is a 25-item survey that asks respondents to indicate the extent to which their partners provided different types of support in the past three months. The SSE-Q consists of subscales on task support, informational support, emotional support, and negative effects of support. For this study, we calculated a total social support score that summed these four subscales (range 0-80). High scores indicate more effective support. Full scale scores can range from 0 to 80, and each subscale can range from 0 to 20.

  2. Instrumental Social Support Support Survey (Cyranowski et al., 2013). [Baseline and Post Intervention at 3 and 6 months]

    The measure consists of 8 questions and asks respondents to indicate on a 5-point scale the extent to which they have received different types of instrumental support in the last month. Higher scores indicate greater support. We report on the count and percentage of individuals with high instrumental support at each time point.

  3. Emotional Support Support (Cyranowski et al., 2013) [Baseline and Post Intervention at 3 and 6 months]

    NIH Toolbox Emotional Support Support Survey. The survey consists of 8 questions and asks respondents to indicate on a 5-point scale the extent to which they have received different types of emotional support in the last month. Higher scores indicate greater support. We report on the count and percentage of individuals with high emotional support at each time point.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Northwestern University Chicago Illinois United States 60611

Sponsors and Collaborators

  • Northwestern University
  • National Institute on Minority Health and Health Disparities (NIMHD)

Investigators

  • Principal Investigator: Darius Tandon, PhD, Northwestern University

Study Documents (Full-Text)

More Information

Publications

Responsible Party:
Darius Tandon, Associate Professor, Northwestern University
ClinicalTrials.gov Identifier:
NCT03427528
Other Study ID Numbers:
  • STU00203918-B
  • 1R21MD011320-01
First Posted:
Feb 9, 2018
Last Update Posted:
Jul 18, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Depression, Postpartum
Depression
Depressive Disorder

Study Results

Participant Flow

Recruitment Details We used a single group longitudinal pre-post design to evaluate study outcomes. Nine HV programs served as project partners and referral sites. These HV programs had been previously trained on MB and had prior experience delivering MB to perinatal women. HV programs participated in a training webinar with study investigators to review FAB implementation, study design and participant recruitment. We received 37 father-mother dyad referrals, of whom 30 (81%) were enrolled.
Pre-assignment Detail
Arm/Group Title FAB Pilot Study (Father Participants) MB 1-on-1 Plus TEXT (Mother Participants)
Arm/Group Description Dyads including the home visiting client (Mom) and her partner (Father) will receive separate interventions. The inventions are complimentary and were implemented in parallel. Fathers received Fathers and Babies (FAB Intervention) while his partner (Mom) will receive MB 1-on-1 plus MB-TXT. Dyads including the HV client (Mom) and her partner (Father) will receive separate interventions. The inventions are complimentary and will be implemented in parallel. HV clients (Mothers) received the Mothers and Babies with -Text Messages intervention (i.e., MB 1-on-1 plus MB-TXT) while her partner (Father) received FAB.
Period Title: Overall Study
STARTED 30 30
COMPLETED 17 23
NOT COMPLETED 13 7

Baseline Characteristics

Arm/Group Title FAB Pilot Study (Father Participants) MB 1-on-1 Plus TEXT (Mother Participants) Total
Arm/Group Description Dyads including a HV client (mother) and her partner (father) will receive separate interventions. The inventions are complimentary and will be implemented in parallel. Dyads including a HV client (mother) and her partner (father) will receive separate interventions. The inventions are complimentary and will be implemented in parallel. Total of all reporting groups
Overall Participants 30 30 60
Age (Count of Participants)
<=18 years
0
0%
0
0%
0
0%
Between 18 and 65 years
30
100%
30
100%
60
100%
>=65 years
0
0%
0
0%
0
0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
27.7
(6.0)
26.5
(5.5)
27.1
(5.6)
Sex: Female, Male (Count of Participants)
Female
0
0%
30
100%
30
50%
Male
30
100%
0
0%
30
50%
Race/Ethnicity, Customized (Count of Participants)
Black/African American
11
36.7%
10
33.3%
21
35%
Hispanic/Latino
9
30%
9
30%
18
30%
White/Caucasian
8
26.7%
8
26.7%
16
26.7%
Other
2
6.7%
3
10%
5
8.3%
Region of Enrollment (Count of Participants)
United States
30
100%
30
100%
60
100%
Educational Attainment (Count of Participants)
< High school degree
3
10%
3
10%
6
10%
High school degree/GED
12
40%
6
20%
18
30%
Some college or beyond
15
50%
21
70%
36
60%
Relationship Status (Count of Participants)
Married
8
26.7%
8
26.7%
16
26.7%
Engaged
5
16.7%
5
16.7%
10
16.7%
Single
10
33.3%
10
33.3%
20
33.3%
Living with partner, not married/engaged
7
23.3%
7
23.3%
14
23.3%
Employment Status (N, %) (Count of Participants)
Not currently working
0
0%
18
60%
18
30%
Working part-time
5
16.7%
7
23.3%
12
20%
Working full-time
25
83.3%
5
16.7%
30
50%
Prenatal enrollees (Count of Participants)
Count of Participants [Participants]
6
20%
6
20%
12
20%
Postnatal enrollees (Count of Participants)
Count of Participants [Participants]
24
80%
24
80%
48
80%

Outcome Measures

1. Primary Outcome
Title Change in Depressive Symptoms
Description Beck Depression Inventory-II (BDI-II) (Beck et al., 1988). The BDI-II was used to assess severity of depressive symptoms consistent with DSM-IV symptom criteria. The BDI-II is a 21-item survey, each item asks respondents to indicate on a scale ranging from 0 to 3 the extent to which they endorse different symptoms of depression over the past two weeks with higher scores indicating greater depression severity, with the highest score of 63. 0-10-considered normal 11-16 Mild mood disturbance 17-20 Borderline clinical depression 21-30 Moderate depression 31-40 Severe depression Over 40 Extreme depression.
Time Frame Baseline and Post Intervention at 3 and 6 months

Outcome Measure Data

Analysis Population Description
Analysis included participants who completed assessments at all time points associated with an analysis.
Arm/Group Title FAB Pilot Study (Father Participants) MB 1-on-1 Plus TEXT (Mother Participants)
Arm/Group Description Dyads including a HV client (mother) and her partner (father) will receive separate interventions. The inventions are complimentary and will be implemented in parallel. Dyads including a HV client (mother) and her partner (father) will receive separate interventions. The inventions are complimentary and will be implemented in parallel.
Measure Participants 30 30
Baseline
6.5
(6.6)
9.7
(8.1)
3 Months
4.5
(4.6)
8.4
(9.5)
6 Months
3.6
(5.1)
8.3
(8.4)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FAB Pilot Study (Father Participants), MB 1-on-1 Plus TEXT (Mother Participants)
Comments We used a single group longitudinal pre-post design to evaluate study outcomes
Type of Statistical Test Other
Comments To assess paternal and maternal outcomes on the BDI-II we conducted a series of paired t-tests with Bonferroni correction for multiple comparisons. T-tests compared baseline scores on each outcome to 3-month follow-up scores, with separate t-tests conducted to examine changes between baseline and 6-month follow-up. We used a Cohen's d statistic to indicate effect sizes for our BDI-II.
Statistical Test of Hypothesis p-Value <0.05
Comments
Method Paired T-test
Comments
2. Primary Outcome
Title Change in Anxiety
Description Generalized Anxiety Disorder 7-item Scale (GAD-7) (Spitzer et al., 2006). The GAD-7 is a 7-item survey, each item asks respondents to indicate on a 4-point scale the extent to which they endorse different symptoms of anxiety over the past two weeks with higher scores indicating greater anxiety symptoms. The highest score is 21. Score 0-4: Minimal Anxiety Score 5-9: Mild Anxiety Score 10-14: Moderate Anxiety Score greater than 15: Severe Anxiety
Time Frame Baseline and Post Intervention at 3 and 6 months

Outcome Measure Data

Analysis Population Description
Analysis was limited to individuals for whom we had complete data at the time points used for analysis.
Arm/Group Title FAB Pilot Study (Father Participants) MB 1-on-1 Plus TEXT (Mother Participants)
Arm/Group Description Dyads including a HV client (mother) and her partner (father) will receive separate interventions. The inventions are complimentary and will be implemented in parallel. Dyads including a HV client (mother) and her partner (father) will receive separate interventions. The inventions are complimentary and will be implemented in parallel.
Measure Participants 30 30
Baseline
4.1
(4.5)
6.8
(5.5)
3 Months
3.2
(3.4)
6.2
(51)
6 Months
2.8
(3.2)
6.3
(4.8)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FAB Pilot Study (Father Participants), MB 1-on-1 Plus TEXT (Mother Participants)
Comments We used a single group longitudinal pre-post design to evaluate study outcomes
Type of Statistical Test Other
Comments To assess paternal and maternal outcomes on the GAD-7, we conducted a series of paired t-tests with Bonferroni correction for multiple comparisons. T-tests compared baseline scores on each outcome to 3-month follow-up scores, with separate t-tests conducted to examine changes between baseline and 6-month follow-up. We used a Cohen's d statistic to indicate effect sizes for our outcomes.
Statistical Test of Hypothesis p-Value >0.05
Comments
Method Paired T-test
Comments
3. Primary Outcome
Title Change in Perceived Stress
Description Perceived Stress Scale 10-item Scale (PSS-10) (Cohen & Williamson, 1988). The PSS-10 is a 10-item survey that asks respondents to indicate on a 5-point scale the extent to which they appraised certain situations as stressful over the past month, with higher scores indicating greater perceived stress. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress. 0-13 are considered low stress Scores ranging from 14-26 are considered moderate stress Scores ranging from 27-40 are considered high perceived stress
Time Frame Baseline and Post Intervention at 3 and 6 months

Outcome Measure Data

Analysis Population Description
Analysis was limited to individuals for whom we had complete data at the time points used for analysis.
Arm/Group Title FAB Pilot Study (Father Participants) MB 1-on-1 Plus TEXT (Mother Participants)
Arm/Group Description Dyads including a HV client (mother) and her partner (father) will receive separate interventions. The inventions are complimentary and will be implemented in parallel. Dyads including a HV client (mother) and her partner (father) will receive separate interventions. The inventions are complimentary and will be implemented in parallel.
Measure Participants 30 30
Baseline
14.9
(7.6)
20.4
(9.1)
3-Month
12.6
(7.1)
16.9
(7.4)
6-Month
10.9
(9.1)
16.8
(6.8)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FAB Pilot Study (Father Participants)
Comments We used a single group longitudinal pre-post design to evaluate study outcomes
Type of Statistical Test Other
Comments To assess paternal and maternal outcomes on the PSS-10, we conducted a series of paired t-tests with Bonferroni correction for multiple comparisons. T-tests compared baseline scores on each outcome to 3-month follow-up scores, with separate t-tests conducted to examine changes between baseline and 6-month follow-up. We used a Cohen's d statistic to indicate effect sizes for our PSS-10 outcomes.
Statistical Test of Hypothesis p-Value <0.05
Comments
Method Paired T-test
Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MB 1-on-1 Plus TEXT (Mother Participants)
Comments We used a single group longitudinal pre-post design to evaluate study outcomes
Type of Statistical Test Other
Comments To assess paternal and maternal outcomes on the PSS-10 we conducted a series of paired t-tests with Bonferroni correction for multiple comparisons. T-tests compared baseline scores on each outcome to 3-month follow-up scores, with separate t-tests conducted to examine changes between baseline and 6-month follow-up. We used a Cohen's d statistic to indicate effect sizes for our PSS-10 outcomes.
Statistical Test of Hypothesis p-Value <0.05
Comments
Method Paired T-test
Comments
4. Secondary Outcome
Title Change in Social Support Effectiveness
Description Social Support Effectiveness Questionnaire (SSE-Q) (Rini et al., 2011). The SSE-Q is a 25-item survey that asks respondents to indicate the extent to which their partners provided different types of support in the past three months. The SSE-Q consists of subscales on task support, informational support, emotional support, and negative effects of support. For this study, we calculated a total social support score that summed these four subscales (range 0-80). High scores indicate more effective support. Full scale scores can range from 0 to 80, and each subscale can range from 0 to 20.
Time Frame Baseline and Post Intervention at 3 and 6 months

Outcome Measure Data

Analysis Population Description
Analysis was limited to individuals for whom we had complete data at the time points used for analysis.
Arm/Group Title FAB Pilot Study (Father Participants) MB 1-on-1 Plus TEXT (Mother Participants)
Arm/Group Description Dyads including a HV client (mother) and her partner (father) will receive separate interventions. The inventions are complimentary and will be implemented in parallel. Dyads including a HV client (mother) and her partner (father) will receive separate interventions. The inventions are complimentary and will be implemented in parallel.
Measure Participants 30 30
Baseline
60.9
(14.3)
48.9
(11.6)
3-Month
57.8
(12.6)
51.4
(14.5)
6-Month
59.3
(13.7)
52.2
(12.2)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FAB Pilot Study (Father Participants), MB 1-on-1 Plus TEXT (Mother Participants)
Comments We used a single group longitudinal pre-post design to evaluate study outcomes
Type of Statistical Test Other
Comments
Statistical Test of Hypothesis p-Value >0.05
Comments
Method t-test, 2 sided
Comments
5. Secondary Outcome
Title Instrumental Social Support Support Survey (Cyranowski et al., 2013).
Description The measure consists of 8 questions and asks respondents to indicate on a 5-point scale the extent to which they have received different types of instrumental support in the last month. Higher scores indicate greater support. We report on the count and percentage of individuals with high instrumental support at each time point.
Time Frame Baseline and Post Intervention at 3 and 6 months

Outcome Measure Data

Analysis Population Description
Analysis was limited to individuals for whom we had complete data at the time points used for analysis.
Arm/Group Title FAB Pilot Study (Father Participants) MB 1-on-1 Plus TEXT (Mother Participants)
Arm/Group Description Dyads including a HV client (mother) and her partner (father) will receive separate interventions. The inventions are complimentary and will be implemented in parallel. Dyads including a HV client (mother) and her partner (father) will receive separate interventions. The inventions are complimentary and will be implemented in parallel.
Measure Participants 30 30
Baseline
9
30%
4
13.3%
3-Month
6
20%
8
26.7%
6-Month
9
30%
9
30%
6. Secondary Outcome
Title Emotional Support Support (Cyranowski et al., 2013)
Description NIH Toolbox Emotional Support Support Survey. The survey consists of 8 questions and asks respondents to indicate on a 5-point scale the extent to which they have received different types of emotional support in the last month. Higher scores indicate greater support. We report on the count and percentage of individuals with high emotional support at each time point.
Time Frame Baseline and Post Intervention at 3 and 6 months

Outcome Measure Data

Analysis Population Description
NIH Toolbox Instrumental Support Support Survey. Each survey consists of 8 questions and asks respondents to indicate on a 5-point scale the extent to which they have received different types of instrumental and emotional support in the last month. Higher scores indicate greater support. Reported on percentage of participants with high levels of instrumental support at all time points.
Arm/Group Title FAB Pilot Study (Father Participants) MB 1-on-1 Plus TEXT (Mother Participants)
Arm/Group Description Dyads including a HV client (mother) and her partner (father) will receive separate interventions. The inventions are complimentary and will be implemented in parallel. Dyads including a HV client (mother) and her partner (father) will receive separate interventions. The inventions are complimentary and will be implemented in parallel.
Measure Participants 30 30
Baseline
9
30%
7
23.3%
3-Month
6
20%
9
30%
6-Month
8
26.7%
5
16.7%

Adverse Events

Time Frame 9 months
Adverse Event Reporting Description There were no adverse events during this project.
Arm/Group Title FAB Pilot Study (Father Participants) MB 1-on-1 Plus TEXT (Mother Participants)
Arm/Group Description Dyads including a HV client (mother) and her partner (father) will receive separate interventions. The inventions are complimentary and will be implemented in parallel. Dyads including a HV client (mother) and her partner (father) will receive separate interventions. The inventions are complimentary and will be implemented in parallel.
All Cause Mortality
FAB Pilot Study (Father Participants) MB 1-on-1 Plus TEXT (Mother Participants)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/30 (0%) 0/30 (0%)
Serious Adverse Events
FAB Pilot Study (Father Participants) MB 1-on-1 Plus TEXT (Mother Participants)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/30 (0%) 0/30 (0%)
Other (Not Including Serious) Adverse Events
FAB Pilot Study (Father Participants) MB 1-on-1 Plus TEXT (Mother Participants)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/30 (0%) 0/30 (0%)

Limitations/Caveats

Our pilot did not include a comparison group, so it is possible that the findings were associated with forces external to FAB. We also were only able to collect pre-birth depressive symptoms from 25% of enrolled fathers given that the other 75% enrolled in the pilot program postnatally. Attrition among fathers at our follow-up time points was also higher than among mothers, thereby limiting generalizability of our findings.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Dr. Darius Tandon
Organization Northwestern University, CCH
Phone +1 312 503 3398
Email dtandon@northwestern.edu
Responsible Party:
Darius Tandon, Associate Professor, Northwestern University
ClinicalTrials.gov Identifier:
NCT03427528
Other Study ID Numbers:
  • STU00203918-B
  • 1R21MD011320-01
First Posted:
Feb 9, 2018
Last Update Posted:
Jul 18, 2022
Last Verified:
Jul 1, 2022