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

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ClinicalTrials.gov Identifier: NCT03427528
Recruitment Status : Recruiting
First Posted : February 9, 2018
Last Update Posted : February 9, 2018
Sponsor:
Collaborator:
National Institute on Minority Health and Health Disparities (NIMHD)
Information provided by (Responsible Party):
Northwestern University

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
Perinatal Depression Postpartum Depression Depression Behavioral: Fathers and Babies (FAB) Behavioral: MB 1-on-1 plus TXT

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 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.
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
Anticipated Study Start Date : February 15, 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

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

Dyads including a female client and her male partner will receive separate interventions. The inventions are complimentary and will be implemented in parallel.

Male partners will receive Fathers and Babies (FAB Intervention) while his female partner will receive MB 1-on-1 plus MB-TXT.

Behavioral: Fathers and Babies (FAB)
Partners of female clients will receive the FAB texts that align with the original MB 1-on-1 intervention. The female partners will receive MB-TXT curriculum (i.e., MB 1-on-1 plus MB-TXT) and their male partners will receive the Home visitors will be responsible for sending texts to both their female clients and the clients' male partners.
Experimental: MB 1-on-1 Plus TEXT (Female Participants)

Dyads including a female client and her male partner will receive separate interventions. The inventions are complimentary and will be implemented in parallel.

Female clients will receive the Mothers and Babies with -Text Messages intervention (i.e., MB 1-on-1 plus MB-TXT) while her male partner will receive FAB.

Behavioral: MB 1-on-1 plus TXT
Female clients will receive the MB-TXT curriculum (i.e., MB 1-on-1 plus MB-TXT) and their male partners will receive the FAB texts that align with the original MB 1-on-1 intervention.Home visitors will be responsible for sending texts to both their female clients and the clients' male partners.



Primary Outcome Measures :
  1. Text messages read by HV clients [ Time Frame: Post Intervention at 6 months ]
    Measured by calculating the percentage of text messages responded to by clients.

  2. Home Visitor Adherence to MB-TXT protocol [ Time Frame: Post Intervention at 6 months ]
    will be measured by using the archived data from HealthySMS to calculate the percentage of texts sent at the appropriate intervals

  3. Client completion of personal projects [ Time Frame: Post Intervention at 6 months ]
    will be measured by asking home visitors to respond to a REDCap survey item after completing each MB session to assess if clients came to the session having completed their personal project.

  4. Client perceived utility and comprehension of text messages [ Time Frame: Post Intervention at 6 months ]
    will be measured by asking home visitors to rate the extent to which each of the 3 text messages received between sessions was a) useful and b) easy to understand. Questions will be on a 4-point Likert Scale and will be asked of clients at the end of each MB session.

  5. Change in the Relationship with Partner [ Time Frame: Baseline and Post Intervention at 6 (MB DAD PILOT ONLY) ]
    will be measured using the Revised Dyadic Adjustment Scale (RDAS). The RDAS measures (a) consensus in decision-making, (b) satisfaction in relationship and (c) cohesion. It contains 14 items, each of which asks respondents to rate certain aspects of his/her relationship on a 5- or 6- point scale. Higher scores indicate greater relationship satisfaction. The RDAS has demonstrated excellent internal consistency.

  6. Change in Fathers' involvement with child [ Time Frame: Baseline and Post Intervention at 6 (MB DAD PILOT ONLY) ]
    will be measured using questions from the Early Childhood Longitudinal Study-Birth Cohort (ECLS-B) which measures (a) engagement in cognitively stimulating activities with child, (b) physical care, (c) paternal warmth, (d) nurturing activities, and (e) caregiving activities.

  7. Change in Perceived social support from partner [ Time Frame: Baseline and Post Intervention at 6 (MB DAD PILOT ONLY) ]
    will be measured using the Perceived Social Support from Family Scale (PSS-Fa). This scale assesses perceived support from family members using a Likert-scale ranging from 1 (strongly disagree) to 4 (strongly agree) to statements regarding feelings and experiences via relationships with family members. We will modify wording of the survey to ask specifically about one's partner.


Secondary Outcome Measures :
  1. Change in Depressive Symptoms [ Time Frame: Baseline and Post Intervention at 6 and 9 months ]
    will be assessed using the Beck Depression Inventory-II (BDI),100 a 21-item self-report measure of depressive symptoms to assess severity of depressive symptoms consistent with DSM-IV symptom criteria. The BDI has excellent internal reliability for outpatient samples and its construct validity has been established.

  2. Change in Cognitive Structuring [ Time Frame: Baseline and Post Intervention at 6 and 9 months ]
    will be measures using the Experiences Questionnaire a 20-item self-report scale measuring decentering and rumination, which has demonstrated strong internal consistency in studies examining effects of interventions that incorporate cognitive restructuring.

  3. Change in Behavioral Activation [ Time Frame: Baseline and Post Intervention at 6 and 9 months ]
    will be measured using the Behavioral Activation Depression Scale, a 25-item, four subscale self-report with strong psychometric properties. The four subscales assess activation, avoidance/rumination, work/school impairment, and social impairment. We will also use a brief checklist adapted from the Pleasant Events Schedule, a psychometrically strong questionnaire. This 25 item self-report contains a list of pleasant events relevant to low-income pregnant women and assesses the extent to which subject's engaged in, and experienced pleasure from, these activities.

  4. Change in Social Support [ Time Frame: Baseline and Post Intervention at 6 and 9 months ]
    19-item Medical Outcomes Study Social Support Survey. This self-administered survey includes an overall functional social support index, as well as four functional support subscales: affectionate, emotional/informational, tangible, and positive social interaction.

  5. Change in Mood regulation [ Time Frame: Baseline and Post Intervention at 6 and 9 months ]
    will be measured using the Negative Mood Regulation Scale (NMRS).The NMRS assesses an individual's expectancy that some behavior or cognition will alleviate a negative mood state. For each question, respondents use a five-point scale from "very much disagree" to "very much agree" to indicate what they believe they can do when they are disappointed or experiencing a negative mood. The scale has demonstrated excellent internal consistency, good test-retest reliability, and correlational evidence of both convergent and discriminant validity with constructs such as depressive symptoms and locus of control, respectively.

  6. Change in Mothers and Babies Skill Utilization [ Time Frame: Baseline and Post Intervention at 6 and 9 months ]
    will be assessed using items developed the study investigators to assess participants utilization of the skills learned in the 12 MB sessions.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03427528


Contacts
Contact: Jaime Hamil, MPH 312-503-2645 jaime.hamil@northwestern.edu

Locations
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Jaime Hamil, MPH    312-503-2645    jaime.hamil@northwestern.edu   
Principal Investigator: Darius Tandon, PhD         
Sponsors and Collaborators
Northwestern University
National Institute on Minority Health and Health Disparities (NIMHD)
Investigators
Principal Investigator: Darius Tandon, PhD Northwestern University

Publications:
Muñoz RF, Le H-N, Ippen CG, et al. Prevention of postpartum depression in low-income women: Development of the Mamás y Bebés/Mothers and Babies course. Cognitive and Behavioral Practice. 2007;14(1):70-83
American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders:: DSM-5. ManMag; 2003
Campbell SB, Cohn JF, Flanagan C, Popper S, Meyers T. Course and correlates of postpartum depression during the transition to parenthood. Development and psychopathology. 1992;4(01):29-47
O'Hara M. Postpartum depression: identification and measurement in a cross-cultural context. Perinatal psychiatry: Use and misuse of the Edinburgh Postnatal Depression Scale. London: Gaskell. 1994:145-168.
Vázquez FL, Muñoz RF, Blanco V, López M. Validation of Muñoz's Mood Screener in a nonclinical Spanish population. European Journal of Psychological Assessment. 2008;24(1):57-64.
U.S. Department of Health and Human Services, Maternal and Child Health Bureau. Women's Health USA 2013. http://mchb.hrsa.gov/whusa13/health-services-utilization/pdf/mhcu.pdf. Accessed October 1.
Lewinsohn P, Muñoz R, Youngren M, Zeiss A. Control Your Depression. Reducing Depression through Learning Self-Control Techniques, Relaxation Training, Pleasant Activities, Social Skills, Constructed Thinking, Planning Ahead and More. New York: Simon & Schuster Inc; 1986
Ainsworth M, Blehar M, Waters E. Wall. s.(1978). Patterns of attachment: A psychological study of the strange situation
Bowlby J. Attachment and loss. Vol 3: Basic books; 1980
Madden M. Technology use by different income groups. 2013; http://www.pewinternet.org/2013/05/29/technology-use-by-different-income-groups/. Accessed February 2, 2016.
Anderson M. Technology device ownership: 2015. 2015; http://www.pewinternet.org/2015/10/29/technology-device-ownership-2015/. Accessed February 2, 2016.
Bronte-Tinkew J, Moore KA, Matthews G, Carrano J. Symptoms of major depression in a sample of fathers of infants sociodemographic correlates and links to father involvement. Journal of family Issues. 2007;28(1):61-99.
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.
Avellar S, Paulsell D, Sama-Miller E, Grosso PD, Akers L, Kleinman R. Home visiting evidence of effectiveness review: Executive summary. Mathematica Policy Research;2013
U.S. Department of Health and Human Services, Administration for Children and Families, Office of Planning and Evaluation. Depression in the Lives of Early Head Start Families: Research to Practice Brief. 2006; http://www.acf.hhs.gov/programs/opre/resource/depression-in-the-lives-of-early-head-start-families-research-to-practice. Accessed January 15, 2014. Accessed January 15, 2016
U.S. Department of Health and Human Services, Health Resources and Services Administration, Maternal and Child Health Bureau. A Comprehensive Approach for Community-Based Programs to Address Intimate Partner Violence and Perinatal Depression. 2013; http://mchb.hrsa.gov/pregnancyandbeyond/depression/partnerviolence/partnerviolenceandperinataldepression.pdf.Accessed February 10 2016.
Prevent Child Abuse America. Healthy Families America Critical Elements. 2001; http://www.healthyfamiliesamerica.org/downloads/critical_elements_rationale.pdf. Accessed January 15, 2016.
Kim HN, Garfield C, Lee YS. Paternal and Maternal Information and Communication Technology Usage as Their Very Low Birth Weight Infants Transition Home From the NICU. International Journal of Human-Computer Interaction. 2015;31(1):44-54.
Kanter JW, Mulick PS, Busch AM, Berlin KS, Martell CR. The Behavioral Activation for Depression Scale (BADS): psychometric properties and factor structure. Journal of Psychopathology and Behavioral Assessment. 2007;29(3):191-202.
Kanter JW, Rusch LC, Busch AM, Sedivy SK. Validation of the Behavioral Activation for Depression Scale (BADS) in a community sample with elevated depressive symptoms. Journal of Psychopathology and Behavioral Assessment. 2009;31(1):36-42.
MacPhillamy DJ, Lewinsohn PM. The pleasant events schedule: Studies on reliability, validity, and scale intercorrelation. Journal of consulting and clinical psychology. 1982;50(3):363
Catanzaro SJ, Greenwood G. Expectancies for negative mood regulation, coping, and dysphoria among college students. Journal of Counseling Psychology. 1994;41(1):34.
Garfield CF, Isacco III AJ. Urban fathers' involvement in their child's health and healthcare. Psychology of Men & Masculinity. 2012;13(1):32.
Tandon SD, Mercer CD, Saylor EL, Duggan AK. Paraprofessional home visitors' perspectives on addressing poor mental health, substance abuse, and domestic violence: A qualitative study. Early Childhood Research Quarterly. 2008;23(3):419-428
Crane DR, Middleton KC, Bean RA. Establishing criterion scores for the Kansas marital satisfaction scale and the revised dyadic adjustment scale. American Journal of Family Therapy. 2000;28(1):53-60.
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.

Responsible Party: Northwestern University
ClinicalTrials.gov Identifier: NCT03427528     History of Changes
Other Study ID Numbers: STU00203918-B
1R21MD011320-01 ( U.S. NIH Grant/Contract )
First Posted: February 9, 2018    Key Record Dates
Last Update Posted: February 9, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
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
Depressive Disorder
Depression, Postpartum
Behavioral Symptoms
Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications