Mental Health Intervention for Black Fathers
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03552783|
Recruitment Status : Recruiting
First Posted : June 12, 2018
Last Update Posted : April 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Mental Health Wellness 1||Behavioral: FFL + Cognitive Behavioral Therapy Behavioral: Fathers for a Lifetime (FFL) only||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|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).|
|Masking Description:||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.|
|Official Title:||Get Your Mind Right: Feasibility of a Mental Health Intervention for African American Fathers in North Omaha|
|Actual Study Start Date :||March 8, 2019|
|Estimated Primary Completion Date :||November 30, 2019|
|Estimated Study Completion Date :||December 31, 2019|
Active Comparator: 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.
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:
Experimental: 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.
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.
- Attrition [ Time Frame: 12 weeks post-randomization ]Follow-up rate: participants who completed the 12 weeks program
- Mental health status [ Time Frame: Baseline; 12 weeks post-randomization ]Defined according to the National Institute of Mental Health definition and DSM-V criteria
- Mental health diagnoses [ Time Frame: Baseline; 12 weeks post-randomization ]National Institute of Mental Health definition and Diagnostic Statistical Manual (DSM)-V criteria
- Daily functioning [ Time Frame: Baseline; 12 weeks post-randomization ]Four out of five domains of the Daily Living Activities (DLA-20) Functional Assessment: coping skills, communication, family relationships, and social networking.
- Number of FFL participants screened [ Time Frame: Baseline ]Number of participants who completed the Intake Form and the DLA-20
- Refusal rates for participation [ Time Frame: Baseline; 12 weeks post-randomization ]Number of participants who decline to participate in the study
- Adherence to study procedures [ Time Frame: Baseline; 12 weeks post-randomization ]Participants who successfully followed the procedure
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): NCT03552783
|Contact: Keyonna M King, DrPH||402-559-3813||Keyonna.King@unmc.edu|
|Contact: Tatiana Tchouankam, MS,MPHfirstname.lastname@example.org|
|United States, Nebraska|
|Charles Drew Health Center, Inc.||Recruiting|
|Omaha, Nebraska, United States, 68111|
|Contact: Tori Conley 402-810-9838 email@example.com|
|Contact: Paul Burnett 402-810-9842 firstname.lastname@example.org|
|Principal Investigator:||Keyonna M King, DrPH||University of Nebraska Medical Center, Center to Reduce health Disparities|
|Study Chair:||Paul Estabrooks, PhD||University of Nebraska Medical Center, College of Public Health|