DepressionAAKOMANCT00578318
African American Knowledge Optimized for Mindfully Healthy Adolescents
A study testing Motivational Interviewing Active in people with Depression, run by Georgetown University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 17 years
- Conditions the study is for
- Depression
- What is being tested?
- Motivational Interviewing Active
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Dec 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Diminished capacity to participate
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Child and Family Study Center
Durham, North Carolina, 27705
About this study
Official title: Treatment Engagement in Psychiatric Clinical Research and Care for Depressed African American Adolescents
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.
Read the 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)
- Conditions
- Depression
- Being tested
- Motivational Interviewing Active
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational Interviewing ActiveBehavioural
Patients received 2 sessions of an in-person talk based intervention utilizing culturally relevant Motivational Interviewing.
| Study group | Role | What they receive |
|---|---|---|
| Motivational Interviewing Active | Experimental | Patients received a stepped progression of talk based treatment utilizing Motivational Interviewing as the basis. Receives: 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) Receives: Behavioral: Motivational Interviewing Active |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Post completion of 2 session Motivational Interviewing (MI) intervention (approximately 3-4 weeks on average during which time study staff followed all patients)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2007 (estimated)
- Study startJun 2007
- Primary completionJan 2010
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Alfiee Breland-Noble, Georgetown University
- Investigators
- Alfiee M Breland-Noble, Ph.D., Principal investigator, Georgetown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00578318
- Sponsor's protocol ID
- Pro00006780 (9065)
- Other IDs
- 1K01MH073814-01A1, 5K01MH073814-02, 5K01MH073814-03
- Acronym
- AAKOMA
- Status last verified
- May 2013
- First submitted
- 19 Dec 2007
- Last updated
- 17 May 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 16768016Breland-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.
PubMed 22984337Breland-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.
PubMed 22354616Breland-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.
PubMed 21512751Breland-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.
PubMed 20564682
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Engagement in Psychiatric Clinical Research and Care for Depressed African American Adolescents
- ClinicalTrials.gov ID
- NCT00578318
- Acronym / sponsor ID
- AAKOMA / Pro00006780 (9065)
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jun 2007
- Primary completion
- Jan 2010 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 21 Dec 2007 (estimated)
- Results
- Posted 17 May 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motivational Interviewing Active | Experimental | Behavioral: Motivational Interviewing ActivePatients received a stepped progression of talk based treatment utilizing Motivational Interviewing as the basis. |
| Delayed Control | Active comparator | Behavioral: Motivational Interviewing ActivePatients received Treatment as usual (TAU) (i.e. no specific intervention and supportive check-ins from the study staff) |
Who may qualify
- Ages
- 11 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Diminished capacity to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational Interviewing ActivePatients received 2 sessions of an in-person talk based intervention utilizing culturally relevant Motivational Interviewing. | Behavioural | Delayed Control, Motivational Interviewing Active |
Primary outcome
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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16768016Breland-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.
- Results publication: PubMed 22984337Breland-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.
- Results publication: PubMed 22354616Breland-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.
- Results publication: PubMed 21512751Breland-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.
- Results publication: PubMed 20564682Breland-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.
- Study WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alfiee M Breland-Noble, Ph.D. principal investigator
Georgetown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Interviewing Active in people with Depression, run by Georgetown University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 May 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00578318, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2013.