Clincosm LogoSign in Get a demo

Mental Health Intervention for Black Fathers

Sponsor
University of Nebraska (Other)
Overall Status
Completed
CT.gov ID
NCT03552783
Collaborator
(none)
10
Enrollment
1
Location
2
Arms
10.4
Actual Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

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
  • Behavioral: FFL + Cognitive Behavioral Therapy
  • Behavioral: Fathers for a Lifetime (FFL) only
 N/A

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

Study Type:
Interventional
Actual Enrollment :
10 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).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 :
Mar 8, 2019
Actual Primary Completion Date :
Nov 30, 2019
Actual Study Completion Date :
Jan 20, 2020

Arms and Interventions

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: Personal responsibility Personal responsibility to your child 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

Primary Outcome Measures

  1. Attrition [12 weeks post-randomization]

    Follow-up rate: participants who completed the 12 weeks program

Secondary Outcome Measures

  1. Mental health status [Baseline; 12 weeks post-randomization]

    Defined according to the National Institute of Mental Health definition and DSM-V criteria

  2. Mental health diagnoses [Baseline; 12 weeks post-randomization]

    National Institute of Mental Health definition and Diagnostic Statistical Manual (DSM)-V criteria

  3. Daily functioning [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 [Baseline]

    Number of participants who completed the Intake Form and the DLA-20

  5. Refusal rates for participation [Baseline; 12 weeks post-randomization]

    Number of participants who decline to participate in the study

  6. Adherence to study procedures [Baseline; 12 weeks post-randomization]

    Participants who successfully followed the procedure

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 Charles Drew Health Center, Inc. Omaha Nebraska United States 68111

Sponsors and Collaborators

  • University of Nebraska

Investigators

  • 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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Keyonna King, PI, University of Nebraska
ClinicalTrials.gov Identifier:
NCT03552783
Other Study ID Numbers:
  • 092-18
First Posted:
Jun 12, 2018
Last Update Posted:
Jan 20, 2021
Last Verified:
Jan 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Keyonna King, PI, University of Nebraska
fathers
parenting
African American

Study Results

No Results Posted as of Jan 20, 2021