Depression, Perinatal Depression, Postpartum Depression
Conditions
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.
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.
Interventions
BEHAVIORALFathers 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.
BEHAVIORALMB 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.
Sponsors
National Institute on Minority Health and Health Disparities (NIMHD)
Northwestern University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
We will conduct an uncontrolled pilot study examining acceptability and feasibility of the Fathers and Babies (FAB) curriculum.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Countries
United States
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.
Participants by arm
| Arm | Count |
|---|---|
| FAB Pilot Study (Father Participants) Dyads including a HV client (mother) and her partner (father) will receive separate interventions. The inventions are complimentary and will be implemented in parallel. | 30 |
| MB 1-on-1 Plus TEXT (Mother Participants) Dyads including a HV client (mother) and her partner (father) will receive separate interventions. The inventions are complimentary and will be implemented in parallel. | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | FAB Pilot Study (Father Participants) | MB 1-on-1 Plus TEXT (Mother Participants) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants | 30 Participants | 60 Participants |
| Age, Continuous | 27.7 years STANDARD_DEVIATION 6 | 26.5 years STANDARD_DEVIATION 5.5 | 27.1 years STANDARD_DEVIATION 5.6 |
| Educational Attainment < High school degree | 3 Participants | 3 Participants | 6 Participants |
| Educational Attainment High school degree/GED | 12 Participants | 6 Participants | 18 Participants |
| Educational Attainment Some college or beyond | 15 Participants | 21 Participants | 36 Participants |
| Employment Status (N, %) Not currently working | 0 Participants | 18 Participants | 18 Participants |
| Employment Status (N, %) Working full-time | 25 Participants | 5 Participants | 30 Participants |
| Employment Status (N, %) Working part-time | 5 Participants | 7 Participants | 12 Participants |
| Postnatal enrollees | 24 Participants | 24 Participants | 48 Participants |
| Prenatal enrollees | 6 Participants | 6 Participants | 12 Participants |
| Race/Ethnicity, Customized Black/African American | 11 Participants | 10 Participants | 21 Participants |
| Race/Ethnicity, Customized Hispanic/Latino | 9 Participants | 9 Participants | 18 Participants |
| Race/Ethnicity, Customized Other | 2 Participants | 3 Participants | 5 Participants |
| Race/Ethnicity, Customized White/Caucasian | 8 Participants | 8 Participants | 16 Participants |
| Region of Enrollment United States | 30 Participants | 30 Participants | 60 Participants |
| Relationship Status Engaged | 5 Participants | 5 Participants | 10 Participants |
| Relationship Status Living with partner, not married/engaged | 7 Participants | 7 Participants | 14 Participants |
| Relationship Status Married | 8 Participants | 8 Participants | 16 Participants |
| Relationship Status Single | 10 Participants | 10 Participants | 20 Participants |
| Sex: Female, Male Female | 0 Participants | 30 Participants | 30 Participants |
| Sex: Female, Male Male | 30 Participants | 0 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
Change in Anxiety
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
Population: Analysis was limited to individuals for whom we had complete data at the time points used for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FAB Pilot Study (Father Participants) | Change in Anxiety | Baseline | 4.1 score on a scale | Standard Deviation 4.5 |
| FAB Pilot Study (Father Participants) | Change in Anxiety | 3 Months | 3.2 score on a scale | Standard Deviation 3.4 |
| FAB Pilot Study (Father Participants) | Change in Anxiety | 6 Months | 2.8 score on a scale | Standard Deviation 3.2 |
| MB 1-on-1 Plus TEXT (Mother Participants) | Change in Anxiety | Baseline | 6.8 score on a scale | Standard Deviation 5.5 |
| MB 1-on-1 Plus TEXT (Mother Participants) | Change in Anxiety | 3 Months | 6.2 score on a scale | Standard Deviation 51 |
| MB 1-on-1 Plus TEXT (Mother Participants) | Change in Anxiety | 6 Months | 6.3 score on a scale | Standard Deviation 4.8 |
Comparison: We used a single group longitudinal pre-post design to evaluate study outcomesp-value: >0.05Paired T-test
Primary
Change in Depressive Symptoms
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
Population: Analysis included participants who completed assessments at all time points associated with an analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FAB Pilot Study (Father Participants) | Change in Depressive Symptoms | Baseline | 6.5 score on a scale | Standard Deviation 6.6 |
| FAB Pilot Study (Father Participants) | Change in Depressive Symptoms | 3 Months | 4.5 score on a scale | Standard Deviation 4.6 |
| FAB Pilot Study (Father Participants) | Change in Depressive Symptoms | 6 Months | 3.6 score on a scale | Standard Deviation 5.1 |
| MB 1-on-1 Plus TEXT (Mother Participants) | Change in Depressive Symptoms | Baseline | 9.7 score on a scale | Standard Deviation 8.1 |
| MB 1-on-1 Plus TEXT (Mother Participants) | Change in Depressive Symptoms | 3 Months | 8.4 score on a scale | Standard Deviation 9.5 |
| MB 1-on-1 Plus TEXT (Mother Participants) | Change in Depressive Symptoms | 6 Months | 8.3 score on a scale | Standard Deviation 8.4 |
Comparison: We used a single group longitudinal pre-post design to evaluate study outcomesp-value: <0.05Paired T-test
Primary
Change in Perceived Stress
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
Population: Analysis was limited to individuals for whom we had complete data at the time points used for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FAB Pilot Study (Father Participants) | Change in Perceived Stress | Baseline | 14.9 score on a scale | Standard Deviation 7.6 |
| FAB Pilot Study (Father Participants) | Change in Perceived Stress | 3-Month | 12.6 score on a scale | Standard Deviation 7.1 |
| FAB Pilot Study (Father Participants) | Change in Perceived Stress | 6-Month | 10.9 score on a scale | Standard Deviation 9.1 |
| MB 1-on-1 Plus TEXT (Mother Participants) | Change in Perceived Stress | Baseline | 20.4 score on a scale | Standard Deviation 9.1 |
| MB 1-on-1 Plus TEXT (Mother Participants) | Change in Perceived Stress | 3-Month | 16.9 score on a scale | Standard Deviation 7.4 |
| MB 1-on-1 Plus TEXT (Mother Participants) | Change in Perceived Stress | 6-Month | 16.8 score on a scale | Standard Deviation 6.8 |
Comparison: We used a single group longitudinal pre-post design to evaluate study outcomesp-value: <0.05Paired T-test
Comparison: We used a single group longitudinal pre-post design to evaluate study outcomesp-value: <0.05Paired T-test
Secondary
Change in Social Support Effectiveness
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
Population: Analysis was limited to individuals for whom we had complete data at the time points used for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FAB Pilot Study (Father Participants) | Change in Social Support Effectiveness | Baseline | 60.9 score on a scale | Standard Deviation 14.3 |
| FAB Pilot Study (Father Participants) | Change in Social Support Effectiveness | 3-Month | 57.8 score on a scale | Standard Deviation 12.6 |
| FAB Pilot Study (Father Participants) | Change in Social Support Effectiveness | 6-Month | 59.3 score on a scale | Standard Deviation 13.7 |
| MB 1-on-1 Plus TEXT (Mother Participants) | Change in Social Support Effectiveness | Baseline | 48.9 score on a scale | Standard Deviation 11.6 |
| MB 1-on-1 Plus TEXT (Mother Participants) | Change in Social Support Effectiveness | 3-Month | 51.4 score on a scale | Standard Deviation 14.5 |
| MB 1-on-1 Plus TEXT (Mother Participants) | Change in Social Support Effectiveness | 6-Month | 52.2 score on a scale | Standard Deviation 12.2 |
Comparison: We used a single group longitudinal pre-post design to evaluate study outcomesp-value: >0.05t-test, 2 sided
Secondary
Emotional Support Support (Cyranowski et al., 2013)
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
Population: 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 | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| FAB Pilot Study (Father Participants) | Emotional Support Support (Cyranowski et al., 2013) | Baseline | 9 Participants |
| FAB Pilot Study (Father Participants) | Emotional Support Support (Cyranowski et al., 2013) | 3-Month | 6 Participants |
| FAB Pilot Study (Father Participants) | Emotional Support Support (Cyranowski et al., 2013) | 6-Month | 8 Participants |
| MB 1-on-1 Plus TEXT (Mother Participants) | Emotional Support Support (Cyranowski et al., 2013) | Baseline | 7 Participants |
| MB 1-on-1 Plus TEXT (Mother Participants) | Emotional Support Support (Cyranowski et al., 2013) | 3-Month | 9 Participants |
| MB 1-on-1 Plus TEXT (Mother Participants) | Emotional Support Support (Cyranowski et al., 2013) | 6-Month | 5 Participants |
Secondary
Instrumental Social Support Support Survey (Cyranowski et al., 2013).
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
Population: Analysis was limited to individuals for whom we had complete data at the time points used for analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| FAB Pilot Study (Father Participants) | Instrumental Social Support Support Survey (Cyranowski et al., 2013). | Baseline | 9 Participants |
| FAB Pilot Study (Father Participants) | Instrumental Social Support Support Survey (Cyranowski et al., 2013). | 3-Month | 6 Participants |
| FAB Pilot Study (Father Participants) | Instrumental Social Support Support Survey (Cyranowski et al., 2013). | 6-Month | 9 Participants |
| MB 1-on-1 Plus TEXT (Mother Participants) | Instrumental Social Support Support Survey (Cyranowski et al., 2013). | Baseline | 4 Participants |
| MB 1-on-1 Plus TEXT (Mother Participants) | Instrumental Social Support Support Survey (Cyranowski et al., 2013). | 3-Month | 8 Participants |
| MB 1-on-1 Plus TEXT (Mother Participants) | Instrumental Social Support Support Survey (Cyranowski et al., 2013). | 6-Month | 9 Participants |