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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21MD011320-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FAB Pilot Study (Father/Male Participants) | Experimental | 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. |
|
| MB 1-on-1 Plus TEXT (Mother/Female Participants) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fathers and Babies (FAB) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and Post Intervention at 3 and 6 months |
| 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 | Baseline and Post Intervention at 3 and 6 months |
| 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 | Baseline and Post Intervention at 3 and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Darius Tandon, PhD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11485953 | Background | Evans J, Heron J, Francomb H, Oke S, Golding J. Cohort study of depressed mood during pregnancy and after childbirth. BMJ. 2001 Aug 4;323(7307):257-60. doi: 10.1136/bmj.323.7307.257. | |
| 15760246 | Background | Gaynes BN, Gavin N, Meltzer-Brody S, Lohr KN, Swinson T, Gartlehner G, Brody S, Miller WC. Perinatal depression: prevalence, screening accuracy, and screening outcomes. Evid Rep Technol Assess (Summ). 2005 Feb;(119):1-8. doi: 10.1037/e439372005-001. No abstract available. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | FAB Pilot Study (Father Participants) | 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. |
| FG001 | MB 1-on-1 Plus TEXT (Mother Participants) | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | MB 1-on-1 Plus TEXT (Mother Participants) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Analysis included participants who completed assessments at all time points associated with an analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline and Post Intervention at 3 and 6 months |
|
9 months
There were no adverse events during this project.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Darius Tandon | Northwestern University, CCH | +1 312 503 3398 | dtandon@northwestern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 1, 2020 | Feb 9, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 1, 2020 | Feb 9, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D019052 | Depression, Postpartum |
| D003863 | Depression |
| ID | Term |
|---|---|
| D011644 | Puerperal Disorders |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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We will conduct an uncontrolled pilot study examining acceptability and feasibility of the Fathers and Babies (FAB) curriculum.
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|
| MB 1-on-1 plus TXT | Behavioral | 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. |
|
| Baseline and Post Intervention at 3 and 6 months |
| 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. | Baseline and Post Intervention at 3 and 6 months |
| 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. | Baseline and Post Intervention at 3 and 6 months |
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| Background | Schmit S, Schott L, Pavetti L, Matthews H. Effective, Evidence-Based Home Visiting Programs in Every State at Risk if Congress Does Not Extend Funding. 2015; http://www.cbpp.org/research/effective-evidence-based-home-visiting-programs-in-every-state-at-risk-if-congress-does-not. Accessed February 10, 2016. |
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| Background | Prevent Child Abuse America. Healthy Families America Critical Elements. 2001; http://www.healthyfamiliesamerica.org/downloads/critical_elements_rationale.pdf. Accessed January 15, 2016. |
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| Background | Garfield CF, Isacco III AJ. Urban fathers' involvement in their child's health and healthcare. Psychology of Men & Masculinity. 2012;13(1):32. |
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| Background | Snow K, Thalji L, Derecho A, et al. Early Childhood Longitudinal Study, Birth Cohort (ECLS-B), Preschool Year Data File User's Manual (2005-06)(NCES 2008-024). Washington, DC: National Center for Education Statistics, Institute of Education Sciences, US Department of Education. 2007:1-190. |
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Dyads including a HV client (mother) and her partner (father) will receive separate interventions. The inventions are complimentary and will be implemented in parallel. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Educational Attainment | Count of Participants | Participants |
|
| Relationship Status | Count of Participants | Participants |
|
| Employment Status (N, %) | Count of Participants | Participants |
|
| Prenatal enrollees | Count of Participants | Participants |
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| Postnatal enrollees | Count of Participants | 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.
| OG001 | 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. |
|
|
|
| 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 | Analysis was limited to individuals for whom we had complete data at the time points used for analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline and Post Intervention at 3 and 6 months |
|
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|
| 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 | Analysis was limited to individuals for whom we had complete data at the time points used for analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline and Post Intervention at 3 and 6 months |
|
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|
|
| 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. | Analysis was limited to individuals for whom we had complete data at the time points used for analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline and Post Intervention at 3 and 6 months |
|
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|
|
| 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. | Analysis was limited to individuals for whom we had complete data at the time points used for analysis. | Posted | Count of Participants | Participants | Baseline and Post Intervention at 3 and 6 months |
|
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| 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. | 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. | Posted | Count of Participants | Participants | No | Baseline and Post Intervention at 3 and 6 months |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | 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. | 0 | 30 | 0 | 30 | 0 | 30 |
Not provided
Not provided
Not provided
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| 3 Months |
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| 6 Months |
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| 3-Month |
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| 6-Month |
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| We used a single group longitudinal pre-post design to evaluate study outcomes | Paired T-test | <0.05 | Other | 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. |
| 3-Month |
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| 6-Month |
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| 3-Month |
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| 6-Month |
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| 3-Month |
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| 6-Month |
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