Suicide Assessment and Feasible Evidence-based Treatments for Youth Living With HIV in Lilongwe: SAFETY Planning Pilot Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Pennsylvania
- Enrollment
- 60
- Locations
- 4
- Primary Endpoint
- Study retention (study feasibility)
Study Overview
Brief Summary
The overall aim of this study is to determine the feasibility, fidelity, acceptability, and preliminary effectiveness of the Friendship Bench +Safety Planning intervention in reducing suicidal ideation and behaviors (SIBs) and improving HIV engagement amongst adolescents living with HIV (ALWH) when compared to augmented usual care.
Detailed Description
This project aims to evaluate the feasibility, acceptability, fidelity, and preliminary effectiveness of the enhanced Friendship Bench+Safety Planning (FB+SP) intervention model. We will enroll 60 depressed ALWH who report suicidality from four facilities in Lilongwe, Malawi, and randomize them 1:1 to the enhanced FB+SP model or augmented usual care. This pilot trial is a step toward our long-term goal of generating and implementing an evidence-based model to prevent suicide in Malawi amongst ALWH by enhancing the capacity of the health system to identify suicidality and provide evidence-based care. Information gathered in this proposal will be used to develop a subsequent randomized control trial.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 13 Years to 19 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 13-19
- •Diagnosed with HIV
- •Report current or historical suicidal ideation and behaviors (SIBs) on question 9 of the Patient Health Questionnaire modified for adolescents (PHQ-9-A) and the Ask Suicide-Screening questionnaire (ASQ)
- •Living in the clinic's catchment area with intention to remain for more than 1 year
- •Willing to provide consent (age 18+ or 16-17 years old and married and thereby considered emancipated minors per Malawi law) or assent with parental consent (age 13-17).
Exclusion Criteria
- •Refuse to participate
- •Refuse to be audio-taped for in-depth interviews
Arms & Interventions
Augmented Usual Care
Continue with usual outpatient care, augmented to provide mental health evaluation, brief supportive counseling, information, education and support on SIBs, and (if indicated) facilitation of referral to the clinic's psychiatric nurse or to Bwaila Hospital.
Intervention: Augmented usual care (Behavioral)
Enhanced Friendship Bench + Safety Planning (FB+SP)
Friendship Bench (FB) problem-solving therapy and Safety Planning (SP)
Intervention: Behavioral: Enhanced Friendship Bench + Safety Planning (Behavioral)
Outcomes
Primary Outcomes
Study retention (study feasibility)
Time Frame: Through study completion- 6 months
This outcome measure of feasibility will be measured as the ability to retain ALWH in the pilot trial. Feasibility will be evaluated by measuring the number of participants retained in the study (number of patients enrolled at baseline who are still enrolled in the trial) through study completion.
Recruitment rate (Intervention feasibility)
Time Frame: Baseline
This outcome measure of feasibility will be measured as the ability to successfully enroll ALWH in the pilot trial. Feasibility will be evaluated by measuring the recruitment rate (number of patients approached in order to accrue the final sample).
Overall satisfaction with the intervention among participants (intervention acceptability)
Time Frame: 6 months
The proportion of participants who found the intervention acceptable and helpful among all participants who received the intervention.
Proportion of sessions meeting fidelity threshold (intervention fidelity)
Time Frame: 6 months
The proportion of sessions meeting or exceeding expectations for at least 80% of the total number of fidelity checklist items assessed per session during random monitoring sessions out of all sessions monitored.
Secondary Outcomes
- Prevalence of suicidal ideation and behaviors(6 months)
- Prevalence of suicide risk(6 months)
- Prevalence of depressive symptoms(6 months)
Investigators
Melissa Stockton
Assistant Professor of Psychiatry
University of Pennsylvania