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

NCT03427528 | Completed Results

• 2 other identifiers: STU00203918-B1R21MD011320-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Perinatal Depression; Postpartum Depression; Depression

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (3)

• Change in Social Support Effectiveness

  Baseline and Post Intervention at 3 and 6 months

• Instrumental Social Support Support Survey (Cyranowski et al., 2013).

  Baseline and Post Intervention at 3 and 6 months

• Emotional Support Support (Cyranowski et al., 2013)

  Baseline and Post Intervention at 3 and 6 months

Study Arms (2)

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.

Behavioral: Fathers and Babies (FAB)

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.

Behavioral: MB 1-on-1 plus TXT

Interventions

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.

FAB Pilot Study (Father/Male Participants)

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.

MB 1-on-1 Plus TEXT (Mother/Female Participants)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

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MeSH Terms

Conditions

Depression, Postpartum; Depression

Interventions

Docetaxel

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Limitations and 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.

Results Point of Contact

• Title: Dr. Darius Tandon
• Organization: Northwestern University, CCH

dtandon@northwestern.edu

+1 312 503 3398

Study Officials

• Darius Tandon, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: We will conduct an uncontrolled pilot study examining acceptability and feasibility of the Fathers and Babies (FAB) curriculum.

Study Record Dates

• First Submitted: January 29, 2018
• First Posted: February 9, 2018
• Study Start: February 15, 2018
• Primary Completion: September 4, 2020
• Study Completion: September 4, 2020
• Last Updated: July 18, 2022
• Results First Posted: July 18, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)