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Mental Health Intervention for Black Fathers

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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

Study Description
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Mental Health Wellness 1 Behavioral: FFL + Cognitive Behavioral Therapy Behavioral: Fathers for a Lifetime (FFL) only Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
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
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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:

  1. Personal responsibility
  2. Personal responsibility to your child
  3. Responsibility to your family and community
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.


Outcome Measures
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Primary Outcome Measures :
  1. Attrition [ Time Frame: 12 weeks post-randomization ]
    Follow-up rate: participants who completed the 12 weeks program


Secondary Outcome Measures :
  1. Mental health status [ Time Frame: Baseline; 12 weeks post-randomization ]
    Defined according to the National Institute of Mental Health definition and DSM-V criteria

  2. Mental health diagnoses [ Time Frame: Baseline; 12 weeks post-randomization ]
    National Institute of Mental Health definition and Diagnostic Statistical Manual (DSM)-V criteria

  3. 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.

  4. Number of FFL participants screened [ Time Frame: Baseline ]
    Number of participants who completed the Intake Form and the DLA-20

  5. Refusal rates for participation [ Time Frame: Baseline; 12 weeks post-randomization ]
    Number of participants who decline to participate in the study

  6. Adherence to study procedures [ Time Frame: Baseline; 12 weeks post-randomization ]
    Participants who successfully followed the procedure


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   FFL is open to new, experienced or estranged African American fathers.
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Contacts
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Contact: Keyonna M King, DrPH 402-559-3813 Keyonna.King@unmc.edu
Contact: Tatiana Tchouankam, MS,MPH 402-800-6141 tatiana.tchouankam@unmc.edu

Locations
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United States, Nebraska
Charles Drew Health Center, Inc. Recruiting
Omaha, Nebraska, United States, 68111
Contact: Tori Conley    402-810-9838    tori.conley@charlesdrew.com   
Contact: Paul Burnett    402-810-9842    paul.burnett@charlesdrew.com   
Sponsors and Collaborators
University of Nebraska
Investigators
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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
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Beck Institute for Cognitive Behavior Therapy. What is cognitive behavior therapy (CBT)?  This link exits the ClinicalTrials.gov site National Institute of Mental Health. RAISE Glossary.  This link exits the ClinicalTrials.gov site

Publications:
Sinkewicz M, Lee R. Prevalence, Comorbidity, and Course of Depression Among Black Fathers in the United States. Research on Social Work Practice 21(3): 289-297, 2011.
Klonoff EA, Landrine H, & Ullman JB. Racial discrimination and psychiatric symptoms among Blacks. Cultural Diversity and Ethnic Minority Psychology 5: 329-339, 1999.
Landrine H, Elisabeth A, Klonoff EA. The Schedule of Racist Events: A Measure of Racial Discrimination and a Study of Its Negative Physical and Mental Health Consequences. Journal of Black Psychology 22: 144-168, 1996.
Clifford LB, Mavaddat R, Hsu SY. The Experience and Consequences of Perceived Racial Discrimination: A Study of African Americans. Journal of Black Psychology 26: 165-180, 2000.
DeNavas-Walt C, Proctor PD, Smith J. Income, poverty, and health insurance coverage in the United States: 2006. Washington, DC: U.S. Census Bureau. 2007.
Huang CC, Warner LA. Relationship characteristics and depression among fathers with newborns. Soc Serv 79: 95-118, 2005.
Nickerson KJ, Helms JE, Terrell F. cultural mistrust, opinions about mental illness, and Black students' attitudes toward seeking psychological help from white counselors. J Counsel Psychol 41: 378-85, 1994.
Halgin RP, Weaver DD, Donaldson PE. College students' perceptions of the advantages and disadvantages of obtaining psychotherapy. J of Soc Service Res 8: 75-86, 1986.
Douglas County Health Department. Maternal child health (MCH) tables, 2016.
Beck Institute for Cognitive Behavior Therapy. What is cognitive behavior therapy (CBT)? Retrieved on December 15 from https://beckinstitute.org/get-informed/what-is-cognitive-therapy/.
National Institute of Mental Health. RAISE Glossary. Retrieved on December 16, 2017 from https://www.nimh.nih.gov/health/topics/schizophrenia/raise/glossary.shtml.
Scott RL, Presmanes WS. Reliability and validity of the Daily Living Activities Scale: a functional assessment measure for severe mental disorders. Res Soc Wk Prac 11(3): 373-389, 2001.

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Responsible Party: Keyonna King, PI, University of Nebraska
ClinicalTrials.gov Identifier: NCT03552783    
Other Study ID Numbers: 092-18
First Posted: June 12, 2018    Key Record Dates
Last Update Posted: April 9, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Keyonna King, University of Nebraska:
fathers
parenting
African American