NCT00578318

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable depression

Timeline
Completed

Started Jun 2007

Longer than P75 for not_applicable depression

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

Study Start

First participant enrolled

June 1, 2007

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 21, 2007

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

May 17, 2013

Completed
Last Updated

May 17, 2013

Status Verified

May 1, 2013

Enrollment Period

2.6 years

First QC Date

December 19, 2007

Results QC Date

January 28, 2013

Last Update Submit

May 15, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

  • Attendance at First Depression Treatment Appointment

    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).

    Post completion of 2 session Motivational Interviewing (MI) intervention (approximately 3-4 weeks on average during which time study staff followed all patients)

Study Arms (2)

Motivational Interviewing Active

EXPERIMENTAL

Patients received a stepped progression of talk based treatment utilizing Motivational Interviewing as the basis.

Behavioral: Motivational Interviewing Active

Delayed Control

ACTIVE COMPARATOR

Patients received Treatment as usual (TAU) (i.e. no specific intervention and supportive check-ins from the study staff)

Behavioral: Motivational Interviewing Active

Interventions

Patients received 2 sessions of an in-person talk based intervention utilizing culturally relevant Motivational Interviewing.

Delayed ControlMotivational Interviewing Active

Eligibility Criteria

Age11 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Diminished capacity to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke Child and Family Study Center

Durham, North Carolina, 27705, United States

Location

Related Publications (5)

  • Breland-Noble AM, Bell C, Nicolas G. Family first: the development of an evidence-based family intervention for increasing participation in psychiatric clinical care and research in depressed African American adolescents. Fam Process. 2006 Jun;45(2):153-69. doi: 10.1111/j.1545-5300.2006.00088.x.

    PMID: 16768016BACKGROUND
  • Breland-Noble AM, Bell CC, Burriss A, Poole HK; The AAKOMA Project Adult Advisory Board. The Significance of Strategic Community Engagement in Recruiting African American Youth & Families for Clinical Research. J Child Fam Stud. 2012 Apr 1;21(2):273-280. doi: 10.1007/s10826-011-9472-1. Epub 2011 Mar 4.

  • Breland-Noble AM; AAKOMA Project Adult Advisory Board. Community and treatment engagement for depressed African American youth: the AAKOMA FLOA pilot. J Clin Psychol Med Settings. 2012 Mar;19(1):41-8. doi: 10.1007/s10880-011-9281-0.

  • Breland-Noble AM, Bell CC, Burriss A; AAKOMA Project Adult Advisory Board. "Mama just won't accept this": adult perspectives on engaging depressed African American teens in clinical research and treatment. J Clin Psychol Med Settings. 2011 Sep;18(3):225-34. doi: 10.1007/s10880-011-9235-6.

  • Breland-Noble AM, Burriss A, Poole HK; AAKOMA PROJECT Adult Advisory Board. Engaging depressed African American adolescents in treatment: lessons from the AAKOMA PROJECT. J Clin Psychol. 2010 Aug;66(8):868-79. doi: 10.1002/jclp.20708.

Related Links

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Limitations and Caveats

We lost 3 participants prior to intervention completion of the intervention which impacted results.

Results Point of Contact

Title
Alfiee M. Breland-Noblem Ph.D., MHSc
Organization
Georgetown University Medical Center

Study Officials

  • Alfiee M Breland-Noble, Ph.D.

    Georgetown University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 19, 2007

First Posted

December 21, 2007

Study Start

June 1, 2007

Primary Completion

January 1, 2010

Study Completion

December 1, 2011

Last Updated

May 17, 2013

Results First Posted

May 17, 2013

Record last verified: 2013-05

Locations