Multiple-Family Group Intervention Programming to Improve Mental Health of Adolescents Living With HIV in Ghana: An Implementation Science Approach

NCT06701942 | Not Yet Recruiting

• 1 other identifier: POS-24-07
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Depressive Disorder; Anxiety Disorder (Panic Disorder or GAD)

Keywords

Multiple family group therapy; Adolescents; HIV/AIDS; Depression; Anxiety

Outcome Measures

Primary Outcomes (2)

• Depression.

  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

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

• Anxiety

  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

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

Secondary Outcomes (1)

• Adherence to Antiretroviral therapy

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

Study Arms (2)

Multiple family group therapy intervention arm

EXPERIMENTAL

ALHIV and their families will be invited to participate in 16 program sessions, each lasting 90 minutes, and will be held on clinic days over a period of 14 weeks. The MFG will combine group discussions and activities fostering support, learning and interaction both within the family and among families. The MFG intervention will be delivered by parent peers and community health workers trained by the study team

Other: Multiple family group intervention therapy

Control Arm

NO INTERVENTION

Clinic allocated to the control group will continue with treatment as usual. This group will not receive the MFGT until after the study period when they may be considered to also receive the intervention to ensure all participants eventually benefit from the program. Until then, the control group will receive the usual standard of care including adherence counselling, adherence support, health education and medical care.

Interventions

Multiple family group intervention therapy OTHER

Overview The intervention will be implemented at designated clinics where adolescents living with HIV/AIDS (ALHIV) and their families currently receive care. These sites will provide the MFG intervention alongside standard care services. All eligible adolescents and their family members who consent to participate will be included in the intervention group. Program Structure The MFG intervention consists of 16 structured sessions, each running for 90 minutes. Sessions will be scheduled to coincide with clinic days over a 14-week period to maximize accessibility and attendance. Parent peers and community health workers, trained by the research team, will facilitate these group sessions. Session Format Sessions on the MFGT will begin with introducing participants to one another, the facilitators, and the program curriculum. Subsequent sessions will concentrate on areas such as respectful communication, support, resilience building, problem-solving, conflict resolution, stress management

Multiple family group therapy intervention arm

Eligibility Criteria

• Age: 10 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Ghana: lead

Related Publications (2)

• Boakye DS, Adjorlolo S. Stakeholder perspectives on contextual barriers to the successful implementation of multiple family group therapy in the Lower Manya Krobo District, Ghana: a qualitative study. BMJ Open. 2025 Sep 8;15(9):e105448. doi: 10.1136/bmjopen-2025-105448.

  PMID: 40921643 DERIVED

• Boakye DS, Adjorlolo S. Multiple-family group intervention programming to improve mental health of adolescents living with HIV/AIDS in Ghana: An implementation science study protocol. PLoS One. 2025 Jun 12;20(6):e0325854. doi: 10.1371/journal.pone.0325854. eCollection 2025.

  PMID: 40504853 DERIVED

MeSH Terms

Conditions

Depressive Disorder; Anxiety Disorders; Panic Disorder; Generalized Anxiety Disorder; Acquired Immunodeficiency Syndrome; Depression

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Behavioral Symptoms; Behavior

Central Study Contacts

Samuel Adjorlolo, PhD, MPhil, MSc, BSc, RN

CONTACT

0240592635; sadjorlolo@ug.edu.gh

Dorothy Serwaa Boakye, PGDE,MPhil, MA, BSc, RN

CONTACT

0249924121; dsboakye001@st.ug.edu.gh

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ms

Study Record Dates

• First Submitted: November 19, 2024
• First Posted: November 22, 2024
• Study Start: January 15, 2025
• Primary Completion: August 20, 2025
• Study Completion (Estimated): December 30, 2026
• Last Updated: November 22, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: The de-identified Individual Participant Data (IPD) and supporting documentation will be made available starting \[insert start date, e.g., six months after primary study results are published\]. This timeframe ensures adequate time for the study team to finalize and publish the primary findings. Data will remain accessible for 5 years after the start date, during which researchers can request access in line with the data-sharing policy. This period may be extended upon review and at the discretion of the study team
• Access Criteria: Individual Participant Data (IPD) Access Statement Access to Individual Participant Data (IPD) and supporting documentation from this study will be available to qualified researchers for non-commercial, academic purposes that align with the goals of advancing public health and scientific knowledge. The following details describe the access framework: Who will be able to access the data? Data access will be granted to researchers affiliated with recognized institutions, universities, or organizations that submit a formal request and demonstrate the scientific merit of their proposed analysis. Applicants must also provide proof of ethical clearance for their secondary analysis and agree to abide by data protection regulations. What will they be able to access? Approved researchers will have access to de-identified participant-level data (IPD), which will include demographic, intervention, and outcome variables relevant to the study objectives.