Clinical trial NCT03552783: Mental Health Intervention for Black Fathers
Official title: Get Your Mind Right: Feasibility of a Mental Health Intervention for African American Fathers in North Omaha
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health Wellness 1
Keywords: fathers
parenting
African American
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2018-06-12
Enrollment: 10
Sex: MALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The intervention will be a quasi-experimental study. The participants will be randomized into one of two study arms: Father For a Lifetime (FFL) + Cognitive Behavioral Therapy (CBT) (intervention arm) or FFL only (comparison arm).
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to examine the feasibility of implementing a mental health intervention, using individual and group Cognitive Behavior Therapy (CBT), embedded into Fathers for a Lifetime; an existing parenting program for fathers. The study will also assess the mental health status and daily functioning of fathers participating in the intervention and comparison arms. The mental health treatments available for parents focused on prevention and treatment of mothers or families but rarely was there a focus on fathers. Our study will use an existing parenting program for fathers to provide a mental health treatment for African American fathers with the intent of creating an effective treatment to screen, diagnosis, increase access to mental health services, and provide mental health treatment. By improving fathers' mental health, we can expect to see improvement in daily functioning, parent-parent interactions, parent-child interactions, increase confidence in parenting skills, and a decrease in parental stress.

Detailed description: The intervention will utilize the Cognitive Behavioral Therapy (CBT), an evidence-based psychotherapeutic approach to addressing mental health issues ranging from anxiety, depression, and other mental illnesses. CBT is based on a cognitive model, the way that individuals perceive a situation is more closely connected to their reaction than the situation itself. The purpose of CBT is to help people focus on how to solve their current problems. The therapist helps the patient learn how to identify distorted or unhelpful thinking patterns, recognize and change inaccurate beliefs, relate to others in more positive ways, and change behaviors accordingly. Participants in the intervention arm will receive 12 weekly, one-hour, group CBT sessions, and three, one-hour, one-on-one therapy sessions throughout the 12-week Father For a LIfetime (FFL) program. We will implement an individual and group CBT mental health intervention that will align with the topics addressed in the FFL weekly curriculum. For instance, the group CBT intervention will examine methods to build resiliency, develop skills to remain calm in stressful situations, learn coping skills when separated from their child/children, and learn how to cope with strained relationships. The FFL curriculum is adapted from the Wise Guys: Male Responsibility Curriculum, an evidence-informed curriculum designed to engage males in the prevention of pregnancies. The curriculum topics are broken into three categories: 1) personal responsibility, 2) responsibility to your child and 3) responsibility to your family and community. Figure 1 below displays the topic description covered each week within each category. The intention of our proposed therapeutic mental health intervention is to improve mental health status utilizing CBT in a group setting and initiating treatment of specific mental illnesses in the one-on-one therapy sessions to meet the unique needs of the father that may not be addressed in a group setting. Participants will receive the intervention immediately after the FFL programming concludes.

The intervention will be delivered by a gender and culturally-matched Licensed Mental Health Professional (LIMHP) who will be trained to deliver the curriculum by the co-investigator and Senior Director of Behavioral Health Services at Charles Drew Health Center. In addition, the men will receive three one-on-one therapy sessions with a Charles Drew LIMHP that will be completed by the end of the FFL program. Participants in the comparison arm will receive the standard, 12-week program curriculum. Our proposed study falls within the T3 translational spectrum, which includes testing an intervention within a community setting by observing and gathering information on implementation to determine feasibility or effectiveness.

Eligibility criteria: Inclusion Criteria:

* African American men
* Father
* 19 or older at the time of the enrollment
* Fluent in English (speaking and reading)
* Reside within the specific zip codes: 68104, 68110, 68111, 68112, and 68131

Exclusion Criteria:

* Females
* Not speaking English

Primary outcomes:
measure: Attrition
timeFrame: 12 weeks post-randomization
Secondary outcomes:
measure: Mental health status
timeFrame: Baseline; 12 weeks post-randomization
measure: Mental health diagnoses
timeFrame: Baseline; 12 weeks post-randomization
measure: Daily functioning
timeFrame: Baseline; 12 weeks post-randomization
measure: Number of FFL participants screened
timeFrame: Baseline
measure: Refusal rates for participation
timeFrame: Baseline; 12 weeks post-randomization
measure: Adherence to study procedures
timeFrame: Baseline; 12 weeks post-randomization
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Charles Drew Health Center, Inc.
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Keyonna M King, DrPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Nebraska
name: Paul Estabrooks, PhD
role: STUDY_CHAIR
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