Phase II Randomised Controlled Trial of Memory Work Therapy at PASADA, Tanzania
MWT
An Evaluation of a Psychosocial Intervention for Orphans With HIV Infection: a Phase II Randomised Controlled Trial of Memory Work Therapy at PASADA, Tanzania
1 other identifier
interventional
48
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable hiv
Started Jun 2013
Shorter than P25 for not_applicable hiv
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 24, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedFirst Posted
Study publicly available on registry
July 3, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedJuly 3, 2014
July 1, 2014
1.1 years
June 24, 2014
July 1, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change: Brief Symptom Inventory
The BSI measures psychological symptom patterns
T0( study entry), T1 (2 weeks), T2 (6 weeks)
Secondary Outcomes (3)
Change: Rosenberg Self-Esteem Scale
T0 (study entry), T1 (2 weeks), T2 (6 weeks)
Change: Goodman's strengths and difficulties questionnaire
T0 (study entry), T1 (2 weeks) T2 (6 weeks)
Change: Self-efficacy questionnaire for children
T0 (study entry), T1 (2 weeks), T2 (6 weeks)
Study Arms (2)
Intervention: Memory Work Therapy
EXPERIMENTALResidential week intervention consisting of memory box, memory book, tree of life, Active Citizen book, all activities facilitated.
Control: standard care
ACTIVE COMPARATORUsual care services.
Interventions
Eligibility Criteria
You may qualify if:
- Aged 14-18 years
- HIV positive
- Orphaned
- Naïve to the intervention
You may not qualify if:
- Adults
- Children under 14
- HIV negative
- Parent(s) living
- Previously attended the intervention
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pastoral Activities and Service for AIDS Dar-Es-Salaam Archdioceselead
- University of Cape Towncollaborator
- King's College Londoncollaborator
Study Sites (1)
PASADA
Temeke, Tanzania
Related Publications (1)
Harding R, Wei G, Gwyther L, Miti E. Improving psychological outcomes for orphans living with HIV in Tanzania through a novel intervention to improve resilience: findings from a pilot RCT. AIDS Care. 2019 Mar;31(3):340-348. doi: 10.1080/09540121.2018.1533630. Epub 2018 Oct 17.
PMID: 30332895DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Social Worker
Study Record Dates
First Submitted
June 24, 2014
First Posted
July 3, 2014
Study Start
June 1, 2013
Primary Completion
July 1, 2014
Study Completion
August 1, 2014
Last Updated
July 3, 2014
Record last verified: 2014-07