Mental Health Intervention for Black Fathers

Mental Health Wellness 1 Clinical Trial

Official title:

Get Your Mind Right: Feasibility of a Mental Health Intervention for African American Fathers in North Omaha

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03552783
• Other study ID #: 0092-18-EP
• Status: Completed
• Phase: N/A
• Start date: March 8, 2019
• Est. completion date: January 20, 2020

Study information

• Verified date: September 2023
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: January 20, 2020
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mental Health Wellness 1

Intervention

Behavioral:
• FFL + Cognitive Behavioral Therapy
Participants in the intervention arm will receive the standard, 12-week program curriculum of Fathers for a Lifetime in addition to 12 weekly, one-hour, group CBT sessions, and three (3), one-hour, one-on-one therapy sessions throughout the 12-week 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.
• Fathers for a Lifetime (FFL) only
The participants in the comparison arm will receive the standard, 12-week program curriculum of Fathers for a Lifetime. The curriculum is broken into three categories: Personal responsibility Personal responsibility to your child Responsibility to your family and community

Locations

Country	Name	City	State
United States	Charles Drew Health Center, Inc.	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
University of Nebraska

Country where clinical trial is conducted

United States, 

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* Note: There are 51 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Attrition	Follow-up rate: participants who completed the 12 weeks program	12 weeks post-randomization
Secondary	Mental health status	Defined according to the National Institute of Mental Health definition and DSM-V criteria	Baseline; 12 weeks post-randomization
Secondary	Mental health diagnoses	National Institute of Mental Health definition and Diagnostic Statistical Manual (DSM)-V criteria	Baseline; 12 weeks post-randomization
Secondary	Daily functioning	Four out of five domains of the Daily Living Activities (DLA-20) Functional Assessment: coping skills, communication, family relationships, and social networking.	Baseline; 12 weeks post-randomization
Secondary	Number of FFL participants screened	Number of participants who completed the Intake Form and the DLA-20	Baseline
Secondary	Refusal rates for participation	Number of participants who decline to participate in the study	Baseline; 12 weeks post-randomization
Secondary	Adherence to study procedures	Participants who successfully followed the procedure	Baseline; 12 weeks post-randomization

External Links

•   National Institute of Mental Health. RAISE Glossary.