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Trial Outcomes & Findings for African American Knowledge Optimized for Mindfully Healthy Adolescents (NCT NCT00578318)

NCT ID: NCT00578318

Last Updated: 2013-05-17

Results Overview

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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

16 participants

Primary outcome timeframe

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

Results posted on

2013-05-17

Participant Flow

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

Participant milestones

Participant milestones
Measure
Motivational Interviewing Active
2 sessions with parent/legal guardian and adolescent study patient of culturally relevant Motivational Interviewing intervention
Delayed Control
At the conclusion of enrollment of all active patients, delayed control patients were offered opportunity to receive culturally relevant Motivational Interviewing intervention.
Overall Study
STARTED
8
8
Overall Study
COMPLETED
5
8
Overall Study
NOT COMPLETED
3
0

Reasons for withdrawal

Reasons for withdrawal
Measure
Motivational Interviewing Active
2 sessions with parent/legal guardian and adolescent study patient of culturally relevant Motivational Interviewing intervention
Delayed Control
At the conclusion of enrollment of all active patients, delayed control patients were offered opportunity to receive culturally relevant Motivational Interviewing intervention.
Overall Study
Lost to Follow-up
2
0
Overall Study
Physician Decision
1
0

Baseline Characteristics

African American Knowledge Optimized for Mindfully Healthy Adolescents

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Motivational Interviewing Active
n=8 Participants
2 sessions with parent/legal guardian and adolescent study patient of culturally relevant Motivational Interviewing intervention
Delayed Control
n=8 Participants
At the conclusion of enrollment of all active patients, delayed control patients were offered opportunity to receive culturally relevant Motivational Interviewing intervention.
Total
n=16 Participants
Total of all reporting groups
Age, Categorical
<=18 years
8 Participants
n=5 Participants
8 Participants
n=7 Participants
16 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Sex: Female, Male
Female
6 Participants
n=5 Participants
7 Participants
n=7 Participants
13 Participants
n=5 Participants
Sex: Female, Male
Male
2 Participants
n=5 Participants
1 Participants
n=7 Participants
3 Participants
n=5 Participants
Region of Enrollment
United States
8 participants
n=5 Participants
8 participants
n=7 Participants
16 participants
n=5 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure
Motivational Interviewing Active
n=8 Participants
2 sessions with parent/legal guardian and adolescent study patient of culturally relevant Motivational Interviewing intervention
Delayed Control
n=8 Participants
At the conclusion of enrollment of all active patients, delayed control patients were offered opportunity to receive culturally relevant Motivational Interviewing intervention.
Attendance at First Depression Treatment Appointment
5 participants
6 participants

Adverse Events

Motivational Interviewing Active

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Delayed Control

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Alfiee M. Breland-Noblem Ph.D., MHSc

Georgetown University Medical Center

Phone: 2026872392

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place