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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
Sponsor:
Information provided by (Responsible Party):
Keyonna King, University of Nebraska

Tracking Information
First Submitted Date  ICMJE April 16, 2018
First Posted Date  ICMJE June 12, 2018
Last Update Posted Date April 9, 2019
Actual Study Start Date  ICMJE March 8, 2019
Estimated Primary Completion Date November 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 8, 2018)
Attrition [ Time Frame: 12 weeks post-randomization ]
Follow-up rate: participants who completed the 12 weeks program
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03552783 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 5, 2019)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: June 8, 2018)
  • 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 DSM-V criteria
  • Daily functioning [ Time Frame: Baseline; 12 weeks post-randomization ]
    Four out of five domains of the Daily Living Activities 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mental Health Intervention for Black Fathers
Official Title  ICMJE Get Your Mind Right: Feasibility of a Mental Health Intervention for African American Fathers in North Omaha
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
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: Single (Participant)
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.
Primary Purpose: Diagnostic
Condition  ICMJE Mental Health Wellness 1
Intervention  ICMJE
  • 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.
  • 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
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Fathers for a Lifetime (FFL) only
  • 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.
    Intervention: Behavioral: FFL + Cognitive Behavioral Therapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 8, 2018)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2019
Estimated Primary Completion Date November 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Gender Eligibility Description: FFL is open to new, experienced or estranged African American fathers.
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Keyonna M King, DrPH 402-559-3813 Keyonna.King@unmc.edu
Contact: Tatiana Tchouankam, MS,MPH 402-800-6141 tatiana.tchouankam@unmc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03552783
Other Study ID Numbers  ICMJE 092-18
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Only the entities involved in the study will have access to the participants' data. The data will be collected and temporarily stored at Charles Drew Health Center (the recruitment site). The participants' data will be stored and analyzed at the Center to Reduce Health Disparities/University of Nebraska Medical Center.
Responsible Party Keyonna King, University of Nebraska
Study Sponsor  ICMJE University of Nebraska
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account University of Nebraska
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP