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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
Boston University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring randomized controlled trial, depression, Uganda, adolescents

Eligibility Criteria

14 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

    First Posted
    January 20, 2006
    Last Updated
    March 10, 2017
    Sponsor
    Boston University
    Collaborators
    World Vision
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    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

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    Study of Treatments for Depression Among Displaced Adolescents in Northern Uganda.

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