Feasibility and Acceptability of the Promoting Resilience in Stress Management (PRISM) Intervention Among Adolescents (10 - 19 Years) Living With HIV in Eswatini: A Single Site, Single-Blind, Randomized Controlled Pilot Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Feasibility of the PRISM intervention
研究概览
简要总结
Adolescents living with Human Immunodeficiency Virus (ALHIV) are at an increased risk of experiencing psychological distress and adverse mental health outcomes, particularly in low- to middle-income countries (LMICs). Although interventions aimed at promoting resilience have demonstrated potential in enhancing psychosocial outcomes among adolescents with chronic illnesses in high-income settings, there is a paucity of evidence from LMICs. This study protocol aims to outline a comprehensive framework for evaluating the feasibility, acceptability, and effectiveness of the Promoting Resilience in Stress Management (PRISM) intervention in comparison to standard psychosocial care among ALHIV in a LMIC, such as Eswatini (formerly known as Swaziland). Additionally, it seeks to gather qualitative insights from both participants and PRISM coaches regarding the PRISM program. Exploratory outcomes under investigation are psychological distress, resilience, and HIV health-related quality of life. We hypothesise that:
- Participants in the PRISM intervention group will experience reduced psychological distress compared to those in the control arm.
- Participants in the PRISM intervention group will report improved HIV health-related quality of life after receiving the intervention compared to the control group.
- Participants in the intervention arm will have higher resilience scores after receiving the intervention compared to those receiving usual psychosocial care.
详细描述
This study employs an explanatory sequential mixed-methods design to rigorously evaluate the Promoting Resilience in Stress Management (PRISM) intervention. In the initial quantitative phase, a single-site, single-blind, pilot randomized controlled trial (RCT) will be conducted. A sample of (n=140) ALHIV will be recruited and randomly assigned to either the PRISM intervention arm or a control arm receiving standard psychosocial care. The PRISM intervention, a manualized, skills-based training program, originally comprises six 30-60-minute, one-on-one sessions designed to enhance resilience resources, including stress management, goal-setting, cognitive reframing, and meaning-making, in adolescents and young adults (AYAs). For the purposes of this trial, the PRISM intervention will be adapted to consist of three 60-minute sessions, delivered at intervals of 1-2 weeks based on participant preference. Participants in both arms will complete validated survey instruments to assess exploratory outcomes, including psychological distress, resilience, and HIV-related quality of life. Data collection will occur at baseline (T0), and at 3 months (T1), 6 months (T2), 9 months (T3), and 12 months (T4) post-enrollment. The researchers will then evaluate the feasibility, acceptability, and effectiveness of the PRISM intervention based on these outcomes.
In the second phase of the study, an Exploratory-Descriptive Qualitative (EDQ) research design will be employed to investigate the experiences and perceptions of participants engaged in the PRISM program. Data collection will involve the use of semi-structured interview guides administered to nurse PRISM coaches and a purposively selected sample of ALHIV from the intervention arm of the pilot clinical trial. The collected data will undergo rigorous thematic analysis to elucidate key insights into the participants' experiences and perceptions of the PRISM intervention, thereby contributing to a deeper understanding of its implementation and impact.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •for the Clinical Trial:
- •Adolescents living with HIV aged 10-19 years.
- •Adolescents living with HIV who are cognitively able to participate in interviews (based on their medical history).
- •Adolescents living with HIV who will have a score > 13 on the Kessler Screening Scale for Psychological Distress (K6).
排除标准
- •for the Clinical Trial:
- •Adolescents who refuse to participate.
- •Adolescents whose parents/caretakers (for <18 years) will not consent to their participation.
- •Adolescents who will report having suicidal thoughts (i.e., who will respond yes to one item asking if they thought of killing themselves in the last 30days). This exclusion is based on the understanding that the PRISM intervention was not designed to address suicidal ideation, as confirmed by its developers. Such individuals will be referred to a licensed psychologist following the study's established referral plan, thereby ensuring they receive the appropriate care and support.
- •Inclusion criteria for a support person:
- •The PRISM intervention requires a caretaker or parent to be invited by the study participant to join the third session.
- •Parent or caretaker should be ≥ 18 years of age and consent to participation.
- •Exclusion criteria for a support person:
- •A parent or caretaker who refuses to participate.
- •Eligibility Criteria for Participation in Semi-Structured Interviews Post Intervention
- •Inclusion criteria for participants:
- •Adolescents who have been in the treatment arm of the PRISM intervention pilot clinical trial.
- •Adolescents who completed all sessions of the PRISM intervention.
- •Adolescents who are willing to be audio taped.
- •Exclusion criteria for participants:
- •Participants who meet the inclusion criteria but are unwilling to provide informed consent or assent and/or parental consent.
- •Inclusion criteria for implementers:
- •PRISM coaches who offered all sessions of the PRISM intervention and who will be willing to be audio-taped.
- •Exclusion criteria for implementers:
- •PRISM coaches who meet the inclusion criteria but are unwilling to provide informed consent to participate.
研究组 & 干预措施
Treatment Arm
Promoting Resilience in Stress Management (PRISM)
Individual, 1:1 version of the Promoting Resilience in Stress Management intervention.
干预措施: Promoting Resilience in Stress Management intervention (Behavioral)
Standard Psychosocial Care
Standard psychosocial care includes comprehensive psychosocial evaluations and referrals to behavioural health services, financial assistance, and various social support resources available at the health facility.
结局指标
主要结局
Feasibility of the PRISM intervention
时间窗: 12 months outcome assessment point.
Feasibility of the PRISM intervention will be defined as priori \>70% program completion of the three PRISM sessions among enrolled participants.
Feasibility of the PRISM intervention
时间窗: 12 months outcome assessment point.
Feasibility of the PRISM intervention will be defined as priori \>70% program completion of the three PRISM sessions among enrolled participants.
Acceptability of the PRISM
时间窗: 12 months outcome assessment point.
Acceptability of the PRISM intervention, which is a primary outcome, will be measured using the Client Satisfaction Questionnaire (CSQ-8), an 8-item measuring participant's opinions and assessments of the intervention. Each item is rated on a 4-point Likert scale, where responses range from 1 (indicating dissatisfaction) to 4 (indicating high satisfaction). The total score, which ranges from 8 to 32, is derived by summing the responses to all eight items. A higher score on the CSQ-8 reflects greater satisfaction with the PRISM intervention.
Acceptability of the PRISM
时间窗: 12 months outcome assessment point.
Acceptability of the PRISM intervention, which is a primary outcome, will be measured using the Client Satisfaction Questionnaire (CSQ-8), an 8-item measuring participant's opinions and assessments of the intervention. Each item is rated on a 4-point Likert scale, where responses range from 1 (indicating dissatisfaction) to 4 (indicating high satisfaction). The total score, which ranges from 8 to 32, is derived by summing the responses to all eight items. A higher score on the CSQ-8 reflects greater satisfaction with the PRISM intervention.
次要结局
- Effectiveness of the PRISM intervention(At 12 months outcome assessment point.)
- Psychological distress(At 3, 6, 9, and 12-months outcome assessment points.)
- Resilience(At 3, 6, 9, and 12-months outcome assessment points.)
- HIV health-related quality of life(At 3, 6, 9, and 12-months outcome assessment points.)
- Effectiveness of the PRISM intervention(At 12 months outcome assessment point.)
- HIV health-related quality of life(At 3, 6, 9, and 12-months outcome assessment points.)
- Psychological distress(At 3, 6, 9, and 12-months outcome assessment points.)
- Resilience(At 3, 6, 9, and 12-months outcome assessment points.)
研究者
Musa Lewis Nhlabatsi
Family Nurse Practitioner
Eswatini Nazarene Health Institutions