TEA for Families and Children: A Randomized Intervention Trial

Health Clinical Trial

Official title: TEA (Together for Empowerment Activities)for Families and Children: A Randomized Intervention Trial

Status Completed

Clinical Trial Summary

The impact of HIV/AIDS is negatively influencing the affected families and their next generation. HIV is radiating through the extended families, shifting the life patterns not only for the parents living with HIV/AIDS (PLH), but also for their children, partners, and other family members. To help PLHs and their family members, the TEA intervention has been developed, refined and piloted in the previous study. The goal of this study is to implement the TEA intervention in a full scale to determine its efficacy and the potential for enhancing HIV policy and programs that support HIV-affected families to cope with the challenges in China in responding to the global HIV epidemic.

Clinical Trial Description

This 5-year project is a randomized controlled trial of the TEA (Together for Empowerment Activities) intervention, a family intervention for HIV-affected families in rural areas of China.

The impact of HIV/AIDS is negatively influencing the affected families and their next generation. Currently in China, there are about 740,000 families living with HIV and 105,000 of them have developed AIDS. HIV is radiating through the extended families, shifting the life patterns not only for the parents living with HIV/AIDS (PLH), but also for their children, partners, and other family members. The negative impact of HIV is compounded by Chinese tradition of accepting illness stoically and not discussing difficult issues within the family due to shame and fear. Chronic illness also reverses the Chinese traditional family roles especially when the ill parents are not capable of contributing to housework or providing financial stability and the further burden rests on the children. As a result, the relationship between parents, family members and children is significantly strained. To help PLHs and their family members, the TEA intervention has been developed, refined and piloted in the previous study. The goal of this study is to implement the TEA intervention in a full scale to determine its efficacy and the potential for enhancing HIV policy and programs that support HIV-affected families to cope with the challenges in China in responding to the global HIV epidemic.

TEA intervention will have six sessions (plus a preparation session) delivered at three levels simultaneously: 1) TEA Gathering (small group for PLH and their family members), 2) TEA Time (home-based family activities with children that accompany each TEA Gathering), and 3) TEA Garden (community events that build social integration). Built on the successful pilot work by the collaborative team, this intervention trial will include 24 administrative villages with 20 families each, resulting in a total of 480 participating families affected by HIV. The administrative villages will be randomized into two groups (12 villages in each): TEA intervention group and control group (with 240 families in each group). A total of 240 PLH, 240 family members and 360 children at age of 6-18 will be recruited in each group. After the baseline assessment, the TEA intervention will be conducted in the intervention group, but not in the control group. Follow-up assessments will be conducted at 6, 12, 18 and 24 months after the intervention is delivered. The impact of the intervention will be assessed by comparing the outcomes measures at baseline and 6-, 12-, 18- and 24-month follow-ups between the intervention and control groups for HIV-affected families, including PLH, family members, and children in poor, rural areas in China (Figure 1). The primary outcomes are children's health, mental health, and behavioral adjustment. The secondary outcomes will be the PLH's and family members' physical health, mental health, and quality of life, as well as family indicators such as family daily routines, positive interactions, parenting, coping, and community integration.

The study will be implemented in Anhui, China. Four counties, Lixin, Funan, Yinzhou and Linquan in Anhui Province have been selected as project sites based on the sample size of HIV-affected families and similarity of demographics. Within the selected counties, the administrative villages that have 20 or more HIV-affected families with at least one child aged 6-18 have been identified based on the current epidemiological data, resulting in a total of 24 villages for this study. Through a randomization procedure, 12 villages will be randomized to TEA intervention group and 12 villages to control group. Only the families that have one PLH, at least one family member, and at least one child aged at 6-18 years will be invited to participate. We will recruit all families from each of the villages, resulting in a total of about 480 HIV-affected families with 480 PLHs, 480 family members and 720 children.

The purpose of this study is to develop a feasible and practical intervention strategy through a randomized controlled intervention trial, which will help HIV-affected families in rural areas of China to face the challenges of HIV and improve their health and quality of life.

The Specific Aims of the study are:

1. To test that the children in the intervention group, compared to those in the control group, will have significantly better physical health, mental health, and behavioral outcomes.

2. To test that the PLH and family members in the intervention group, compared to those in the control group, will have significantly improved physical health, mental health, and quality of life outcomes.

3. To investigate how outcomes of the children, PLH, and family members are mediated by family indicators such as consistent daily routines, positive family interactions, parenting, coping, and community integration. ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Behaviors
• Health

• NCT number: NCT01762553
• Study type: Interventional
• Source: University of California, Los Angeles
• Status: Completed
• Phase: N/A
• Start date: May 2011
• Completion date: June 2015