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African American Knowledge Optimized for Mindfully Healthy Adolescents (AAKOMA)

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Alfiee Breland-Noble, Georgetown University
ClinicalTrials.gov Identifier:
NCT00578318
First received: December 19, 2007
Last updated: May 15, 2013
Last verified: May 2013
History of Changes
  Purpose

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 Intervention
Depression
 Behavioral: Motivational Interviewing Active

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment Engagement in Psychiatric Clinical Research and Care for Depressed African American Adolescents

Resource links provided by NLM:

MedlinePlus related topics: Depression
U.S. FDA Resources

Further study details as provided by Georgetown University:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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).


Enrollment: 16
Study Start Date: June 2007
Study Completion Date: December 2011
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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)

  Eligibility

Ages Eligible for Study:   11 Years to 17 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
Study Website  This link exits the ClinicalTrials.gov site

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, 5K01MH073814-02, 5K01MH073814-03
Study First Received: December 19, 2007
Results First Received: January 28, 2013
Last Updated: May 15, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 23, 2013