- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02180750
Phase II Randomised Controlled Trial of Memory Work Therapy at PASADA, Tanzania (MWT)
July 1, 2014 updated by: Elvis Joseph Miti, Pastoral Activities and Service for AIDS Dar-Es-Salaam Archdiocese
An Evaluation of a Psychosocial Intervention for Orphans With HIV Infection: a Phase II Randomised Controlled Trial of Memory Work Therapy at PASADA, Tanzania
Memory Work Therapy (MWT) has been developed to improve psycho-social outcomes for children living with HIV who are orphaned.
This phase 2 trial aims to determine whether attending the intervention improves outcomes compared to standard care.
We aim to test the hypothesis that attendance at MWT improves psychological symptoms, self-esteem, emotional and behavioural difficulties, and self-efficacy compared to standard care.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
48
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Temeke, Tanzania
- PASADA
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Aged 14-18 years
- HIV positive
- Orphaned
- Naïve to the intervention
Exclusion Criteria:
- Adults
- Children under 14
- HIV negative
- Parent(s) living
- Previously attended the intervention
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention: Memory Work Therapy
Residential week intervention consisting of memory box, memory book, tree of life, Active Citizen book, all activities facilitated.
|
|
Active Comparator: Control: standard care
Usual care services.
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Pediatric clinic, ART
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change: Brief Symptom Inventory
Time Frame: T0( study entry), T1 (2 weeks), T2 (6 weeks)
|
The BSI measures psychological symptom patterns
|
T0( study entry), T1 (2 weeks), T2 (6 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change: Rosenberg Self-Esteem Scale
Time Frame: T0 (study entry), T1 (2 weeks), T2 (6 weeks)
|
A measure of self esteem
|
T0 (study entry), T1 (2 weeks), T2 (6 weeks)
|
Change: Goodman's strengths and difficulties questionnaire
Time Frame: T0 (study entry), T1 (2 weeks) T2 (6 weeks)
|
Measures mental health in children and young people
|
T0 (study entry), T1 (2 weeks) T2 (6 weeks)
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Change: Self-efficacy questionnaire for children
Time Frame: T0 (study entry), T1 (2 weeks), T2 (6 weeks)
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measure emotional and social self-efficacy.
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T0 (study entry), T1 (2 weeks), T2 (6 weeks)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2013
Primary Completion (Anticipated)
July 1, 2014
Study Completion (Anticipated)
August 1, 2014
Study Registration Dates
First Submitted
June 24, 2014
First Submitted That Met QC Criteria
July 1, 2014
First Posted (Estimate)
July 3, 2014
Study Record Updates
Last Update Posted (Estimate)
July 3, 2014
Last Update Submitted That Met QC Criteria
July 1, 2014
Last Verified
July 1, 2014
More Information
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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