Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
10 participants
Study Classification
INTERVENTIONAL
Study Start Date
2019-03-08
Study Completion Date
2020-01-20
Brief Summary
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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.
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Detailed Description
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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.
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.
Conditions
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Mental Health Wellness 1
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
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 Study Purpose
DIAGNOSTIC
Blinding Strategy
SINGLE
Participants
The program coordinator is intimately involved with program participants as his role includes completing the intakes with each participant, implementing the program, and for the purpose of the study, the screening process. To eliminate the bias, the program coordinator will continue to collect intake data and screen the participants. However, we will include a Licensed Mental Health Professional (LIMHP) who will utilize the screening information to complete the comprehensive assessment, randomize, and enroll the participants in the study. In addition, the LIMHP will also complete the follow-up data collection. This will prevent researcher bias during program delivery.
Study Groups
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Fathers for a Lifetime (FFL) only
The participants in the comparison arm will receive the standard, 12-week program curriculum of Father For a Lifetime.
Group Type
ACTIVE_COMPARATOR
Fathers for a Lifetime (FFL) only
Intervention Type
BEHAVIORAL
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:
1. Personal responsibility
2. Personal responsibility to your child
3. Responsibility to your family and community
FFL + Cognitive Behavioral Therapy
The participants in the intervention will receive will the standard, 12-week program curriculum of Father For a Lifetime and the Cognitive Behavioral Therapy. The intervention will be delivered by a gender and culturally-matched Licensed Mental Health Professional (LIMHP). 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.
Group Type
EXPERIMENTAL
FFL + Cognitive Behavioral Therapy
Intervention Type
BEHAVIORAL
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.
Interventions
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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.
Intervention Type
BEHAVIORAL
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:
1. Personal responsibility
2. Personal responsibility to your child
3. Responsibility to your family and community
Intervention Type
BEHAVIORAL
Eligibility Criteria
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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
* 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
* Not speaking English
Minimum Eligible Age
19 Years
Eligible Sex
MALE
Accepts Healthy Volunteers
Yes
Sponsors
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University of Nebraska
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Keyonna M King, DrPH
Role: PRINCIPAL_INVESTIGATOR
University of Nebraska
Paul Estabrooks, PhD
Role: STUDY_CHAIR
University of Nebraska
Locations
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Charles Drew Health Center, Inc.
Omaha, Nebraska, United States
Site Status
Countries
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United States
References
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Related Links
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https://www.nimh.nih.gov/health/topics/schizophrenia/raise/glossary.shtml
National Institute of Mental Health. RAISE Glossary.
Other Identifiers
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0092-18-EP
Identifier Type: -
Identifier Source: org_study_id
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