NCT03552783

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 12, 2018

Completed
9 months until next milestone

Study Start

First participant enrolled

March 8, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2020

Completed
Last Updated

September 29, 2023

Status Verified

September 1, 2023

Enrollment Period

9 months

First QC Date

April 16, 2018

Last Update Submit

September 27, 2023

Conditions

Keywords

fathersparentingAfrican American

Outcome Measures

Primary Outcomes (1)

  • Attrition

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

    12 weeks post-randomization

Secondary Outcomes (6)

  • Mental health status

    Baseline; 12 weeks post-randomization

  • Mental health diagnoses

    Baseline; 12 weeks post-randomization

  • Daily functioning

    Baseline; 12 weeks post-randomization

  • Number of FFL participants screened

    Baseline

  • Refusal rates for participation

    Baseline; 12 weeks post-randomization

  • +1 more secondary outcomes

Study Arms (2)

Fathers for a Lifetime (FFL) only

ACTIVE COMPARATOR

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

FFL + Cognitive Behavioral Therapy

EXPERIMENTAL

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

Interventions

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.

FFL + Cognitive Behavioral Therapy

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

Fathers for a Lifetime (FFL) only

Eligibility Criteria

Age19 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsFFL is open to new, experienced or estranged African American fathers.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • African American men
  • Father
  • 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

You may not qualify if:

  • Females
  • Not speaking English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charles Drew Health Center, Inc.

Omaha, Nebraska, 68111, United States

Location

Related Publications (51)

  • 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.

    BACKGROUND
  • Klonoff EA, Landrine H, & Ullman JB. Racial discrimination and psychiatric symptoms among Blacks. Cultural Diversity and Ethnic Minority Psychology 5: 329-339, 1999.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • Sellers SL, Bonham V, Neighbors HW, Amell JW. Effects of racial discrimination and health behaviors on mental and physical health of middle-class African American men. Health Educ Behav. 2009 Feb;36(1):31-44. doi: 10.1177/1090198106293526. Epub 2006 Nov 27.

    PMID: 17130248BACKGROUND
  • Rosin RD. Perspectives--IJS Issue No. 4, 2009. Int J Surg. 2009 Aug;7(4):277-8. doi: 10.1016/j.ijsu.2009.07.007. Epub 2009 Jul 23. No abstract available.

    PMID: 19631298BACKGROUND
  • 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.

    BACKGROUND
  • Huang CC, Warner LA. Relationship characteristics and depression among fathers with newborns. Soc Serv 79: 95-118, 2005.

    BACKGROUND
  • DeKlyen M, Brooks-Gunn J, McLanahan S, Knab J. The mental health of married, cohabiting, and non-coresident parents with infants. Am J Public Health. 2006 Oct;96(10):1836-41. doi: 10.2105/AJPH.2004.049296. Epub 2006 Mar 29.

    PMID: 16571717BACKGROUND
  • Amrock SM, Weitzman M. Parental psychological distress and children's mental health: results of a national survey. Acad Pediatr. 2014 Jul-Aug;14(4):375-81. doi: 10.1016/j.acap.2014.02.005. Epub 2014 May 29.

    PMID: 24882378BACKGROUND
  • Paulson JF, Dauber S, Leiferman JA. Individual and combined effects of postpartum depression in mothers and fathers on parenting behavior. Pediatrics. 2006 Aug;118(2):659-68. doi: 10.1542/peds.2005-2948.

    PMID: 16882821BACKGROUND
  • Kane P, Garber J. The relations among depression in fathers, children's psychopathology, and father-child conflict: a meta-analysis. Clin Psychol Rev. 2004 Jul;24(3):339-60. doi: 10.1016/j.cpr.2004.03.004.

    PMID: 15245835BACKGROUND
  • Das Eiden R, Leonard KE. Paternal alcoholism, parental psychopathology, and aggravation with infants. J Subst Abuse. 2000;11(1):17-29. doi: 10.1016/s0899-3289(99)00016-4.

    PMID: 10756511BACKGROUND
  • McMahon TJ, Winkel JD, Rounsaville BJ. Drug abuse and responsible fathering: a comparative study of men enrolled in methadone maintenance treatment. Addiction. 2008 Feb;103(2):269-83. doi: 10.1111/j.1360-0443.2007.02075.x.

    PMID: 18199306BACKGROUND
  • Beardslee WR, Gladstone TR, Wright EJ, Cooper AB. A family-based approach to the prevention of depressive symptoms in children at risk: evidence of parental and child change. Pediatrics. 2003 Aug;112(2):e119-31. doi: 10.1542/peds.112.2.e119.

    PMID: 12897317BACKGROUND
  • Klein DN, Lewinsohn PM, Rohde P, Seeley JR, Olino TM. Psychopathology in the adolescent and young adult offspring of a community sample of mothers and fathers with major depression. Psychol Med. 2005 Mar;35(3):353-65. doi: 10.1017/s0033291704003587.

    PMID: 15841871BACKGROUND
  • Lieb R, Isensee B, Hofler M, Pfister H, Wittchen HU. Parental major depression and the risk of depression and other mental disorders in offspring: a prospective-longitudinal community study. Arch Gen Psychiatry. 2002 Apr;59(4):365-74. doi: 10.1001/archpsyc.59.4.365.

    PMID: 11926937BACKGROUND
  • Cooke CG, Kelley ML, Fals-Stewart W, Golden J. A comparison of the psychosocial functioning of children with drug-versus alcohol-dependent fathers. Am J Drug Alcohol Abuse. 2004 Nov;30(4):695-710. doi: 10.1081/ada-200037530.

    PMID: 15624545BACKGROUND
  • Griffith DM, Neighbors HW, Johnson J. Using national data sets to improve the health and mental health of Black Americans: challenges and opportunities. Cultur Divers Ethnic Minor Psychol. 2009 Jan;15(1):86-95. doi: 10.1037/a0013594.

    PMID: 19209983BACKGROUND
  • Yorgason JB, Linville D, Zitzman B. Mental health among college students: do those who need services know about and use them? J Am Coll Health. 2008 Sep-Oct;57(2):173-81. doi: 10.3200/JACH.57.2.173-182.

    PMID: 18809534BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • Hines-Martin V, Malone M, Kim S, Brown-Piper A. Barriers to mental health care access in an African American population. Issues Ment Health Nurs. 2003 Apr-May;24(3):237-56. doi: 10.1080/01612840305281.

    PMID: 12623684BACKGROUND
  • Ayalon L, Young MA. Racial group differences in help-seeking behaviors. J Soc Psychol. 2005 Aug;145(4):391-403. doi: 10.3200/SOCP.145.4.391-404.

    PMID: 16050338BACKGROUND
  • Barksdale CL, Molock SD. Perceived norms and mental health help seeking among African American college students. J Behav Health Serv Res. 2009 Jul;36(3):285-99. doi: 10.1007/s11414-008-9138-y. Epub 2008 Jul 31.

    PMID: 18668368BACKGROUND
  • Bender DS, Skodol AE, Dyck IR, Markowitz JC, Shea MT, Yen S, Sanislow CA, Pinto A, Zanarini MC, McGlashan TH, Gunderson JG, Daversa MT, Grilo CM. Ethnicity and mental health treatment utilization by patients with personality disorders. J Consult Clin Psychol. 2007 Dec;75(6):992-9. doi: 10.1037/0022-006X.75.6.992.

    PMID: 18085915BACKGROUND
  • Copeland VC, Butler J. Reconceptualizing access: a cultural competence approach to improving the mental health of African American women. Soc Work Public Health. 2007;23(2-3):35-58. doi: 10.1080/19371910802148263.

    PMID: 19306587BACKGROUND
  • Woodward AT, Taylor RJ, Chatters LM. Use of Professional and Informal Support by Black Men with Mental Disorders. Res Soc Work Pract. 2011 Jul;21(3):328-336. doi: 10.1177/1049731510388668.

    PMID: 21686069BACKGROUND
  • Douglas County Health Department. Maternal child health (MCH) tables, 2016.

    BACKGROUND
  • McCarter-Spaulding D, Shea S. Effectiveness of Discharge Education on Postpartum Depression. MCN Am J Matern Child Nurs. 2016 May-Jun;41(3):168-72. doi: 10.1097/NMC.0000000000000236.

    PMID: 27128643BACKGROUND
  • Wozney L, Olthuis J, Lingley-Pottie P, McGrath PJ, Chaplin W, Elgar F, Cheney B, Huguet A, Turner K, Kennedy J. Strongest Families Managing Our Mood (MOM): a randomized controlled trial of a distance intervention for women with postpartum depression. Arch Womens Ment Health. 2017 Aug;20(4):525-537. doi: 10.1007/s00737-017-0732-y. Epub 2017 Jun 7.

    PMID: 28593360BACKGROUND
  • Howland M, Armeli S, Feinn R, Tennen H. Daily emotional stress reactivity in emerging adulthood: temporal stability and its predictors. Anxiety Stress Coping. 2017 Mar;30(2):121-132. doi: 10.1080/10615806.2016.1228904. Epub 2016 Oct 1.

    PMID: 27635675BACKGROUND
  • Melnyk BM, Feinstein NF, Alpert-Gillis L, Fairbanks E, Crean HF, Sinkin RA, Stone PW, Small L, Tu X, Gross SJ. Reducing premature infants' length of stay and improving parents' mental health outcomes with the Creating Opportunities for Parent Empowerment (COPE) neonatal intensive care unit program: a randomized, controlled trial. Pediatrics. 2006 Nov;118(5):e1414-27. doi: 10.1542/peds.2005-2580. Epub 2006 Oct 16.

    PMID: 17043133BACKGROUND
  • Welch MG, Myers MM. Advances in family-based interventions in the neonatal ICU. Curr Opin Pediatr. 2016 Apr;28(2):163-9. doi: 10.1097/MOP.0000000000000322.

    PMID: 26886783BACKGROUND
  • Stahl ST, Albert SM, Dew MA, Lockovich MH, Reynolds CF 3rd. Coaching in healthy dietary practices in at-risk older adults: a case of indicated depression prevention. Am J Psychiatry. 2014 May;171(5):499-505. doi: 10.1176/appi.ajp.2013.13101373.

    PMID: 24788282BACKGROUND
  • Kuyken W, Hayes R, Barrett B, Byng R, Dalgleish T, Kessler D, Lewis G, Watkins E, Brejcha C, Cardy J, Causley A, Cowderoy S, Evans A, Gradinger F, Kaur S, Lanham P, Morant N, Richards J, Shah P, Sutton H, Vicary R, Weaver A, Wilks J, Williams M, Taylor RS, Byford S. Effectiveness and cost-effectiveness of mindfulness-based cognitive therapy compared with maintenance antidepressant treatment in the prevention of depressive relapse or recurrence (PREVENT): a randomised controlled trial. Lancet. 2015 Jul 4;386(9988):63-73. doi: 10.1016/S0140-6736(14)62222-4. Epub 2015 Apr 20.

    PMID: 25907157BACKGROUND
  • Munshi K, Eisendrath S, Delucchi K. Preliminary long-term follow-up of Mindfulness-based cognitive therapy-induced remission of depression. Mindfulness (N Y). 2013 Dec 1;4(4):354-361. doi: 10.1007/s12671-012-0135-0.

    PMID: 24443660BACKGROUND
  • Sandler I, Gunn H, Mazza G, Tein JY, Wolchik S, Berkel C, Jones S, Porter M. Effects of a Program to Promote High Quality Parenting by Divorced and Separated Fathers. Prev Sci. 2018 May;19(4):538-548. doi: 10.1007/s11121-017-0841-x.

    PMID: 28913663BACKGROUND
  • Doyle O, Joe S, Caldwell CH. Ethnic differences in mental illness and mental health service use among Black fathers. Am J Public Health. 2012 May;102 Suppl 2(Suppl 2):S222-31. doi: 10.2105/AJPH.2011.300446. Epub 2012 Mar 8.

    PMID: 22401518BACKGROUND
  • Demontigny F, Girard ME, Lacharite C, Dubeau D, Devault A. Psychosocial factors associated with paternal postnatal depression. J Affect Disord. 2013 Aug 15;150(1):44-9. doi: 10.1016/j.jad.2013.01.048. Epub 2013 Mar 13.

    PMID: 23489392BACKGROUND
  • Waller H, Craig T, Landau S, Fornells-Ambrojo M, Hassanali N, Iredale C, Jolley S, McCrone P, Garety P. The effects of a brief CBT intervention, delivered by frontline mental health staff, to promote recovery in people with psychosis and comorbid anxiety or depression (the GOALS study): study protocol for a randomized controlled trial. Trials. 2014 Jun 27;15:255. doi: 10.1186/1745-6215-15-255.

    PMID: 24973026BACKGROUND
  • Sadler P, McLaren S, Klein B, Jenkins M, Harvey J. Cognitive behaviour therapy for older adults experiencing insomnia and depression in a community mental health setting: Study protocol for a randomised controlled trial. Trials. 2015 Nov 27;16:538. doi: 10.1186/s13063-015-1066-6.

    PMID: 26614277BACKGROUND
  • Eccleston C, Fisher E, Law E, Bartlett J, Palermo TM. Psychological interventions for parents of children and adolescents with chronic illness. Cochrane Database Syst Rev. 2015 Apr 15;4(4):CD009660. doi: 10.1002/14651858.CD009660.pub3.

    PMID: 25874881BACKGROUND
  • Taylor HL, Rybarczyk BD, Nay W, Leszczyszyn D. Effectiveness of a CBT Intervention for Persistent Insomnia and Hypnotic Dependency in an Outpatient Psychiatry Clinic. J Clin Psychol. 2015 Jul;71(7):666-83. doi: 10.1002/jclp.22186. Epub 2015 Apr 23.

    PMID: 25907406BACKGROUND
  • Lopez MA, Basco MA. Effectiveness of cognitive behavioral therapy in public mental health: comparison to treatment as usual for treatment-resistant depression. Adm Policy Ment Health. 2015 Jan;42(1):87-98. doi: 10.1007/s10488-014-0546-4.

    PMID: 24692026BACKGROUND
  • 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/.

    BACKGROUND
  • National Institute of Mental Health. RAISE Glossary. Retrieved on December 16, 2017 from https://www.nimh.nih.gov/health/topics/schizophrenia/raise/glossary.shtml.

    BACKGROUND
  • Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012 Mar;50(3):217-26. doi: 10.1097/MLR.0b013e3182408812.

    PMID: 22310560BACKGROUND
  • 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.

    BACKGROUND
  • McGrew JH, Bond GR, Dietzen L, Salyers M. Measuring the fidelity of implementation of a mental health program model. J Consult Clin Psychol. 1994 Aug;62(4):670-8. doi: 10.1037//0022-006x.62.4.670.

    PMID: 7962870BACKGROUND
  • Bond GR, Evans L, Salyers MP, Williams J, Kim HW. Measurement of fidelity in psychiatric rehabilitation. Ment Health Serv Res. 2000 Jun;2(2):75-87. doi: 10.1023/a:1010153020697.

    PMID: 11256719BACKGROUND

Related Links

MeSH Terms

Interventions

Cognitive Behavioral TherapySingle Person

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesMarital StatusFamily CharacteristicsDemographyPopulation CharacteristicsSocioeconomic Factors

Study Officials

  • Keyonna M King, DrPH

    University of Nebraska

    PRINCIPAL INVESTIGATOR
  • Paul Estabrooks, PhD

    University of Nebraska

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
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.
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2018

First Posted

June 12, 2018

Study Start

March 8, 2019

Primary Completion

November 30, 2019

Study Completion

January 20, 2020

Last Updated

September 29, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

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.

Locations