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African American Knowledge Optimized for Mindfully Healthy Adolescents

Treatment Engagement in Psychiatric Clinical Research and Care for Depressed African American Adolescents

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00578318
Acronym
AAKOMA
Enrollment
16
Registered
2007-12-21
Start date
2007-06-30
Completion date
2011-12-31
Last updated
2013-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

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.

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)

Interventions

BEHAVIORALMotivational Interviewing Active

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

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
Georgetown University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
11 Years to 17 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Attendance at First Depression Treatment AppointmentPost 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).

Countries

United States

Participant flow

Recruitment details

Study patients were recruited from the local community using tested, strategic community engagement procedures.

Participants by arm

ArmCount
Motivational Interviewing Active
2 sessions with parent/legal guardian and adolescent study patient of culturally relevant Motivational Interviewing intervention
8
Delayed Control
At the conclusion of enrollment of all active patients, delayed control patients were offered opportunity to receive culturally relevant Motivational Interviewing intervention.
8
Total16

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up20
Overall StudyPhysician Decision10

Baseline characteristics

CharacteristicMotivational Interviewing ActiveTotalDelayed Control
Age, Categorical
<=18 years
8 Participants16 Participants8 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants
Region of Enrollment
United States
8 participants16 participants8 participants
Sex: Female, Male
Female
6 Participants13 Participants7 Participants
Sex: Female, Male
Male
2 Participants3 Participants1 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

Primary

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).

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)

ArmMeasureValue (NUMBER)
Motivational Interviewing ActiveAttendance at First Depression Treatment Appointment5 participants
Delayed ControlAttendance at First Depression Treatment Appointment6 participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026