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African American Knowledge Optimized for Mindfully Healthy Adolescents (AAKOMA)

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ClinicalTrials.gov Identifier: NCT00578318
Recruitment Status : Completed
First Posted : December 21, 2007
Results First Posted : May 17, 2013
Last Update Posted : May 17, 2013
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Alfiee Breland-Noble, Georgetown University

Brief Summary:
The purpose of this study was to better understand how African American families identify and treat emotional and behavioral concerns associated with depression in their adolescent youth. The goals of the study included (a) identifying factors associated with participation in psychiatric research and treatment and (b) developing an intervention to increase participation in psychiatric research and treatment.

Condition or disease Intervention/treatment Phase
Depression Behavioral: Motivational Interviewing Active Not Applicable

Detailed Description:

The aim of this study was to obtain an in-depth understanding of African Americans' perceptions of barriers to adolescent and family engagement in psychiatric treatment and research utilizing a mixed methods approach in two Phases. Phase I consisted of data collected via surveys, focus groups and individual interviews with African American adults and youth. The data generated in Phase I provided a foundation for the domains incorporated into manual development and therapist training procedures of the subsequent intervention phase of the project (Phase II).

After the research team developed the depression treatment engagement intervention, the intervention was pilot tested in a sample of depressed African American youth and families (Phase II)


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment Engagement in Psychiatric Clinical Research and Care for Depressed African American Adolescents
Study Start Date : June 2007
Actual Primary Completion Date : January 2010
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Motivational Interviewing Active
Patients received a stepped progression of talk based treatment utilizing Motivational Interviewing as the basis.
Behavioral: Motivational Interviewing Active
Patients received 2 sessions of an in-person talk based intervention utilizing culturally relevant Motivational Interviewing.
Active Comparator: Delayed Control
Patients received Treatment as usual (TAU) (i.e. no specific intervention and supportive check-ins from the study staff)
Behavioral: Motivational Interviewing Active
Patients received 2 sessions of an in-person talk based intervention utilizing culturally relevant Motivational Interviewing.



Primary Outcome Measures :
  1. Attendance at First Depression Treatment Appointment [ Time Frame: Post completion of 2 session Motivational Interviewing (MI) intervention (approximately 3-4 weeks on average during which time study staff followed all patients) ]
    Patients were randomized to the intervention or a delayed control group. The primary outcome was bifurcated as yes or no to specify whether or not the patient attended the first available depression treatment appointment scheduled after he/she completed the AAKOMA protocol. The average time to attendance at the first session was approximately 3-4 weeks and during this intermediate time between completion of the protocol and initiation of treatment all patients were followed by study staff).



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Ages Eligible for Study:   11 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Persons who self-identify as Black or African American
  • Adolescents aged 11 to 17 at the time of recruitment
  • Adult parents
  • Parent consent and adolescent assent
  • Demonstrated cognitive ability to understand participation

Exclusion Criteria:

  • Diminished capacity to participate

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): NCT00578318


Locations
United States, North Carolina
Duke Child and Family Study Center
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Georgetown University
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Alfiee M Breland-Noble, Ph.D. Georgetown University

Additional Information:
Publications of Results:
Other Publications:
Responsible Party: Alfiee Breland-Noble, Assistant Professor, Georgetown University
ClinicalTrials.gov Identifier: NCT00578318     History of Changes
Other Study ID Numbers: Pro00006780 (9065)
1K01MH073814-01A1 ( U.S. NIH Grant/Contract )
5K01MH073814-02 ( U.S. NIH Grant/Contract )
5K01MH073814-03 ( U.S. NIH Grant/Contract )
First Posted: December 21, 2007    Key Record Dates
Results First Posted: May 17, 2013
Last Update Posted: May 17, 2013
Last Verified: May 2013