跳至主要内容
临床试验/NCT06701942
NCT06701942尚未招募不适用

Multiple-Family Group Intervention Programming to Improve Mental Health of Adolescents Living With HIV/AIDS in Ghana: An Implementation Science Study Protocol.

University of Ghana0 个研究点目标入组 80 人开始时间: 2025年1月15日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
80
主要终点
Depression.

研究概览

简要总结

When young people living with HIV don't get the mental health support they need, it can lead to a lot of problems. Not only do they suffer from mental health issues, but it also makes it harder for them to stick to their HIV treatment, practice safe sex, go to school regularly, and do well in their studies.

Because of these challenges, experts are urging that we take action to address the mental health needs of these adolescents. They believe that our healthcare system should provide a more comprehensive approach that includes mental health services for these young people. This would not only improve their HIV treatment but also give more people access to mental healthcare around the world.

Being a teenager with HIV is especially difficult, so it's crucial they get the right support, including help with their mental health, to navigate this stage of life. However, many studies show that mental health issues in young people living with HIV, especially in poorer areas, are often ignored. These places often have underfunded and poorly organized healthcare systems, making it even harder to address these problems.

There have been significant advances in treating and preventing HIV, and with the right medication, young people with HIV can now live almost as long as those without the virus. Ghana, like many other countries, has committed to the global goal of ensuring that 95% of people living with HIV are diagnosed, 95% of those diagnosed start treatment, and 95% of those on treatment achieve and maintain low levels of the virus. But these goals are hard to reach without addressing the significant mental health and substance abuse issues faced by adolescents living with HIV.

In Ghana and other low-resource areas, the healthcare system is struggling. Mental health services are rarely included in the basic healthcare that young people living with HIV receive. Most psychiatric units in hospitals are underfunded, so these young people are often referred to specialized hospitals for mental health support. However, financial difficulties, distance, and other barriers prevent many from accessing these services, leaving their mental health needs unmet.

To address this issue, it's essential to integrate mental health services into primary care for adolescents living with HIV. One promising approach is the Multiple Family Group Therapy (MFGT), which could provide much-needed support in these settings.

Multiple Family Group Therapy (MFGT) is a very affordable way to address the emotional and social challenges faced by young people living with HIV and their families. It's a proven method that's listed in the U.S. national registry of effective programs because it uses minimal resources to achieve positive mental health outcomes for many participants.

MFGT was initially designed to help children with behavior problems and their parents, but it has since been used to address a wide range of issues like depression and anxiety in different groups, including people living with HIV. The program is structured and combines group and family therapy, focusing on building skills and improving family dynamics through what are called the 4Rs (Rules, Responsibility, Relationship, and Respectful communication) and 2Ss (Stress and Social support).

The main goal of MFGT is to create a space where families who are dealing with similar challenges can support each other and learn together, all with the aim of improving mental health and behavior. The program helps participants stay engaged with healthcare services, stick to their treatment, reduce symptoms, prevent relapses, and improve their overall quality of life.

Although MFGT was developed in the West and is based on several theories like family systems and social learning, it has been successfully adapted for use in low-resource settings like Ghana. It's particularly appealing in these areas because it can be facilitated by non-professionals such as lay counselors, community health workers, or even parents. This aligns with the World Health Organization's strategy of task-shifting, which involves training non-mental health professionals to provide basic mental health support.

详细描述

Globally, 38.4 million people are living with HIV, of which 1.7 million are children aged 0-14 years (UNAIDS, 2022). Sub-Saharan Africa contributes substantially to the HIV burden, reflected in the high HIV prevalence, mortality and morbidity (Kharsany & Karim, 2016). Relating to Ghana, about 1.7% of population is living with HIV, with adolescents aged 15-19 years contributing to 0.7% of the HIV burden (Agyemang et al., 2020). The diagnosis of HIV potentiates a cascade of mental health problems that impact all aspect of HIV prevention, treatment/management. This vulnerability is significantly elevated in adolescents who have heightened risk for mental health problems owing to their developmental stage (Wright et al., 2021). In a recent global meta-analytic study, the prevalence of depression among ALHIV was 26.07%, with females (32.15%) and older adolescents aged 15-19 years (37.09%) recording the highest rate than males (25.07%) and younger adolescents aged 10-14 years (29.82%), respectively (Ayano et al., 2021).

Focusing on SSA, a recent systematic review found that 25% ALHIV screened positive for any psychiatric disorder, whereas 30-50% presented with emotional, behavioral difficulties or significant psychological distress (Dessauvagie et al., 2020). Despite the paucity of epidemiological studies in Ghana, existing evidence suggests that ALHIV suffer from discrimination and rejection, ushering them into profound psychological distress such as suicidal thoughts and hopelessness (Doat et al., 2021) that often culminate into poorer psychosocial adjustment (Doku, 2010). Unaddressed mental health problems in ALHIV not only contribute to mental health burden but also negatively impact on treatment adherence, prevention of HIV through adoption of safe sexual practices and behaviors, school attendance and academic achievement (Remien et al., 2019).

In view of the above, analysts have called for a proactive response to the mental health issues in ALHIV(Bhana et al., 2021). In particular, the healthcare systems has been admonished to provide integrated healthcare to ALHIV that includes mental health (Dessauvagie et al., 2020; Vreeman et al., 2017). Doing so would not only strengthen HIV prevention and care outcomes, but it would additionally improve global access to mental healthcare (Remien et al., 2019). Indeed, living with HIV as an adolescent raises the exigency for effective support and guidance, including addressing mental health issues, to ensure they traverse through this developmental stage (Hodgson et al., 2012). However, the literature is replete with the general neglect of mental health problems in ALHIV, particularly in low resource settings where investment in and delivery of mental health are notably poor and disorganized (Essien & Asamoah, 2020). Significant advances have been made in the prevention and treatment of HIV. For example, adolescents diagnosed with HIV can expect a near normal life span given access and adherence to combination anti-retroviral therapy (cART)(Mills et al., 2011; Teeraananchai et al., 2017). Ghana, like other countries have subscribed to the Joint United Nations Programme on HIV/AIDs goal of 95-95-95 call for 95% of people living with HIV (PLWH) to be diagnosed, with 95% of them initiating cART, and 95% of those on cART to achieve and sustain viral suppression through adherence to the treatment. However, these gains will not be achieved without addressing the significant mental and substance use problems among ALHIV(Remien et al., 2019). The lack of research and support for mental health needs in Ghana and other resource-limited settings presents an enormous burden for which cost-effective solutions are urgently needed (Vreeman et al., 2017).

The Multiple Family Group Therapy (MFGT) is an extremely cost-effective interventions that has the tendency to address psychosocial burden holistically among ALHIV and their significant others simultaneously. Listed on the national Registry of evidence-based programs in the US, the MFGT uses relatively minimal resources to achieve positive mental health outcomes for different participants. It was originally developed to target children with disruptive behavior disorders, their parents and service providers but has since been applied to address a range of psychopathological behaviors such as depression, anxiety in different population, including individuals living with HIV(Sensoy Bahar et al., 2020). As a structured program and a hybrid of group and family interventions, the MFGT is focused on improving skills and family processes referred to as 4Rs (Rules, Responsibility, Relationship and Respectful communication) and 2Ss (Stress and Social support). The key therapeutic aim of MFGT is to foster mutual support and learning between families who face similar difficulties and are united by a common goal of improving mental health and behavioral outcomes (Loh et al., 2021). It aims to support engagement with healthcare service, treatment adherence, symptoms reduction, relapse prevention, and quality of life. The MFGT is a Western-based model with strong theoretical underpinning, been a derivative of multiple theories such as family systems, structural family, and social learning theories. It is also anchored in psychoeducation and social group work. The MFGT is attractive in low resource settings such as Ghana given that it has been successfully facilitated by lay counsellors, community health workers, village health team and/or parent peers(McKay et al., 2004; Mellins et al., 2014). This is consistent with the task shifting strategy proposed by the WHO to address mental health problems by empowering non-mental health professionals to provide essential and basic mental health support(Adjorlolo et al., 2019).

The major caveats in relation to the application of the MFGT in Ghana are two-fold. First, the MFGT is formulated based on predominantly individualistic, western family principles, processes and practices that starkly contrast family systems in predominantly collective societies, including Ghana. This questions the application of the MFGT in Ghana without recourse to Ghanaian family systems and practices(Asampong et al., 2021; Sensoy Bahar et al., 2020); an observation that necessitates the adaption of the MFGT to increase its sensitivity to the local settings and family systems in Ghana. Although some versions of the MFGT have been incorporated into a family-based HIV prevention intervention (i.e., CHAMP program) in South Africa (McKay et al., 2004; Mellins et al., 2014) and family focused economic strengthening intervention (SUUBI program) in Uganda(Ssewamala et al., 2014), this is the first attempt to wholly adapt the MFGT to address mental health and psychosocial issues in ALHIV in SSA, focusing on Ghana. Previous effort to adapt the MFGT in Uganda has centered on adolescents with disruptive behaviors disorders in educational settings; a population that is functionally and psychological distinct from ALHIV, including family structures and functioning. Besides, none of the previous efforts were aimed at healthcare system strengthening to deliver integrated health services that include mental health support. Owing to the limited human resource, finance and logistics, the healthcare system in Ghana, just like other countries in SSA, is fragmented mostly at the primary level. Mental health services are barely integrated into the primary healthcare for ALHIV. Most of the psychiatric units of the Ghanaian hospitals are poorly resourced, making referrals of ALHIV in need of mental support to psychiatric hospitals the most viable option. However, financial problems and geographic barriers and others limit the utilization of the referral system, leaving the mental health of ALHIV unaddressed. This demands the integration of mental health support system into the primary care for ALHIV; the MFGT holds significant prospects in this regard.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
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

入选标准

  • Adolescents:
  • Aged 10-19 years (as per WHO definition of adolescence) Confirmed HIV-positive status Currently receiving antiretroviral therapy (ART) Aware of their HIV status Residing in Lower Manya Krobo district Able to communicate in either English or the local language Willing to participate in group sessions
  • Caregivers/family:
  • Primary caregiver of an eligible adolescent participant Aged 18 years or older Aware of the adolescent's HIV status Residing in Lower Manya Krobo district Able to communicate in either English or the local language Willing to participate in group sessions

排除标准

  • Adolescents:
  • Presence of severe cognitive impairment that would prevent participation in group activities Acute psychiatric conditions requiring immediate intensive treatment Current participation in another mental health intervention study Unable to provide assent or obtain caregiver consent
  • Primary Caregivers/Family:
  • Presence of severe cognitive impairment that would prevent participation in group activities Acute psychiatric conditions requiring immediate intensive treatment Unable to provide informed consent
  • Both Adolescents and Caregivers:
  • Planning to relocate outside of Lower Manya Krobo district within the next 12 months Unable to commit to attending the majority of planned group sessions

结局指标

主要结局

Depression.

时间窗: Baseline, immediate post intervention and 3, and 6 months follow-up

Depression will be assessed with the Patient Health Questionnaire-9 (PHQ-9) (Kroenke et al., 2001) which has been validated for use with adolescents and in Ghanaian settings (Adjorlolo, 2019) The PHQ-9 has 9 items, each scored 0-3, with a total score range 0-27 Scores ≥10 indicate moderate to severe depressive symptoms

Anxiety

时间窗: Baseline, immediate post intervention and 3, and 6 months follow-up

Anxiety will be assessed with the Generalized Anxiety Disorder-7 (GAD-7) (Spitzer et al., 2006), whic has also been validated for use in Ghanaian adolescents (Anum et al., 2019). The GAD-7 has 7 items, each scored 0-3, with a total score range of 0-21. Scores ≥10 indicate moderate to severe anxiety symptoms

次要结局

  • Adherence to Antiretroviral therapy(Baseline, immediate post intervention and 3, and 6 months follow-up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dorothy Serwaa Boakye

Ms

University of Ghana

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