Study of Treatments for Depression Among Displaced Adolescents in Northern Uganda.
Primary Purpose
Depression
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
interpersonal psychotherapy for groups
creative play therapy
Sponsored by

About this trial
This is an interventional treatment trial for Depression focused on measuring randomized controlled trial, depression, Uganda, adolescents
Eligibility Criteria
Inclusion Criteria: aged 14-17 years. living in displaced persons camps in northern Uganda meet study-specific criteria for depression Exclusion Criteria: reported age of less than 14 or older than 17 years does not live in a displaced persons camp
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
IPT arm
CP arm
control
Arm Description
interpersonal psychotherapy for groups (IPT-G). this consists of psychotherapy provided to participants in a group format.
Creative Play therapy consists of play activities provided to participants in groups.
those who are wait-list controls
Outcomes
Primary Outcome Measures
depression
adapted depression instrument - HSCL.
Secondary Outcome Measures
Full Information
NCT ID
NCT00280319
First Posted
January 20, 2006
Last Updated
March 10, 2017
Sponsor
Boston University
Collaborators
World Vision
1. Study Identification
Unique Protocol Identification Number
NCT00280319
Brief Title
Study of Treatments for Depression Among Displaced Adolescents in Northern Uganda.
Official Title
Randomized Controlled Study of Non-pharmacologic Treatments for Depression Among Displaced Adolescents in Northern Uganda.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
December 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston University
Collaborators
World Vision
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
That interpersonal psychotherapy and creative play therapies can reduce symptoms of depression among adolescents with depressive-type illness in northern Uganda.
Detailed Description
This study represents the third phase of a project aimed at developing, validating, and using locally-relevant assessments of emotional and behavioral problems in Acholi war-affected children to evaluate interventions being delivered by non-governmental organizations in the N. of Uganda. It is positioned to make a unique contribution to the field by both developing culturally appropriate screening and assessment methods and then using them to assess the efficacy of an adapted, manualized treatment both pre-and post-intervention.
The intent of the proposed intervention study is to test the efficacy of group interpersonal psychotherapy (IPT) for treatment of specific psychosocial problems and associated impairment in Acholi IDP adolescents living in the Unyama and Awer camps of Gulu District, Northern Uganda. These interventions represent the existing standard of care provided by NGOs working in this region, but. for tje first time, collaboration of the NGOs in this study will help ensure systematic assessment of participants to investigate the efficacy of interventions being offered.
The proposed research study aims to test the efficacy of a group treatment for emotional and behavioral problems in war-affected adolescents. Emotional and behavioral problems will be assessed using a locally-validated scale of psychosocial problems and functional impairment developed from ethnographic work conducted in the same IDP camps in Gulu District in July 2004. The intervention to be tested will be group interpersonal therapy (IPT) which has shown efficacy for use in treating depression in Ugandan adults In Masaka and Rakai provinces. The decision to use IPT in this IDP population was based on the fact that symptoms similar to depression and comorbid anxiety, for which IPT is indicated, dominated in the ethnographic assessment of emotional and behavioral problems collected in July. Additionally, we have prior direct experience in Uganda that IPT can be easily trained and systematically delivered in a low-resource environment lay practitioners and that it is effective in treating depression. Furthermore, our ethnographic work has resulted in a suitable measure for assessing emotional and behavioral problems in war- affected Acholi youth living in the Northern Uganda for use in screening adolescents into intervention groups. The application of valid instruments to assess psychosocial problems and the degree of impairment both pre and post- intervention will be invaluable to our implementing partners - World Vision/War Child - for developing effective interventions to address the ongoing mental health needs of the young people they serve in Northern Uganda.
Specific Objectives 1. To assess symptoms of locally described depression-like syndromes (Kumu/Par/Two Tam), a local anxiety syndrome (Ma Lwor) and social problems (Gin lugero/tic marac) in Acholi war-affected adolescents using the Acholi Psychosocial Assessment Instrument (APAI), a locally-derived tool for assessment of emotional and behavioral problems in children and youth available in the Luo language.
2. To randomly assign screened individuals found to have these problems to one of three treatment conditions including: a) group IPT; b) a facilitated arts & recreation control condition; and c) a wait-list control condition.
3. To conduct post-intervention testing and comparison of all treatment conditions using the APAI. This will be done immediately after the IPT intervention is completed, and repeated 6 months later.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
randomized controlled trial, depression, Uganda, adolescents
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
338 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IPT arm
Arm Type
Experimental
Arm Description
interpersonal psychotherapy for groups (IPT-G). this consists of psychotherapy provided to participants in a group format.
Arm Title
CP arm
Arm Type
Experimental
Arm Description
Creative Play therapy consists of play activities provided to participants in groups.
Arm Title
control
Arm Type
No Intervention
Arm Description
those who are wait-list controls
Intervention Type
Behavioral
Intervention Name(s)
interpersonal psychotherapy for groups
Intervention Description
psychotherapy
Intervention Type
Behavioral
Intervention Name(s)
creative play therapy
Intervention Description
consisted of play activities
Primary Outcome Measure Information:
Title
depression
Description
adapted depression instrument - HSCL.
Time Frame
pre, post and 6 months post treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
aged 14-17 years. living in displaced persons camps in northern Uganda meet study-specific criteria for depression
Exclusion Criteria:
reported age of less than 14 or older than 17 years does not live in a displaced persons camp
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Bolton, MB BS
Organizational Affiliation
Boston University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
17666672
Citation
Bolton P, Bass J, Betancourt T, Speelman L, Onyango G, Clougherty KF, Neugebauer R, Murray L, Verdeli H. Interventions for depression symptoms among adolescent survivors of war and displacement in northern Uganda: a randomized controlled trial. JAMA. 2007 Aug 1;298(5):519-27. doi: 10.1001/jama.298.5.519.
Results Reference
derived
Learn more about this trial
Study of Treatments for Depression Among Displaced Adolescents in Northern Uganda.
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