TEA for Families and Children: A Randomized Intervention Trial
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|ClinicalTrials.gov Identifier: NCT01762553|
Recruitment Status : Completed
First Posted : January 7, 2013
Last Update Posted : February 18, 2016
|First Submitted Date ICMJE||January 4, 2013|
|First Posted Date ICMJE||January 7, 2013|
|Last Update Posted Date||February 18, 2016|
|Study Start Date ICMJE||May 2011|
|Actual Primary Completion Date||June 2015 (Final data collection date for primary outcome measure)|
|Current Primary Outcome Measures ICMJE
||children's behavior problems and health [ Time Frame: Change from baseline to 6-, 12-, 18-, and 24 month follow up ]
During the intervention pilot, we conducted assessments for children aged 6-12 and 13-18, respectively. We also asked adults questions regarding their children's behavior. Health for children will be assessed by the questions from the China Global School-Based Student Health Survey.50 Questions from the China Children Health and Nutrition Survey will be filled out by PLH. Mental health will be measured by the Everyday Stress Index (α=0.79), and the Rosenberg Self-Esteem Scale54 (α=0.69). For children aged 13-18, the Emotional Quotient Scale (α=0.69) including subscales of motivation, relationship, and satisfaction will be administered. Behavioral adjustment will be measured by their self reports on school performance and satisfaction, consistent family routines (α=0.60), peer relations, and delinquent behaviors (α=0.70).
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT01762553 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||People living with HIV and Family member [ Time Frame: Change from baseline to 6-. 12-, 18-, and 24 month follow up ]
Health of the PLH and FM will be assessed by using the Medical Outcomes Study (MOS)-HIV for PLH and MOS-Short Form-36 (SF-36) for family members. For PLH's health, MOS-HIV physical functioning (α=0.85), pain, energy/fatigue (α=0.85), and health distress (α=0.72) will be used. For FMs' health, MOS-SF36 will be used (α=0.89). Mental health of PLH will be assessed using MOS-HIV mental health scale (α=0.84) and cognitive functioning scale (α=0.65). For both PLH and FM, Zung Self-Rating Depression Scale will be used to assess their level of depressive symptoms. This instrument has been used by our team twice in the pilot studies (α=0.80 for PLH and α=0.83 for FM). PTSD will be measured by a brief 7-item scale (α=0.77) for PLH only. FM burden will be assessed with the Perceived Caregiver Burden Scale (PCB). Quality of life of PLH will be assessed using MOS-HIV general health perceptions (α=0.81) and role functioning (α=0.79).
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||TEA for Families and Children: A Randomized Intervention Trial|
|Official Title ICMJE||TEA (Together for Empowerment Activities)for Families and Children: A Randomized Intervention Trial|
|Brief 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.|
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:
|Study Type ICMJE||Interventional|
|Study Phase||Not Applicable|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
|Intervention ICMJE||Behavioral: The TEA intervention
TEA Gathering is a small group training session for PLH and their family members to deal with HIV-related challenges at individual level; TEA Time is home based family activities for PLHs and their family members to interact with their children after each TEA Gathering to promote family positive interaction; TEA Garden is the community events that built social integration for HIV affected families to live a healthy social life and to build sustained, supportive relationships in their communities. There will be reunions once a month for 12 months after the completion of the TEA intervention.
|Publications *||Li L, Ji G, Liang LJ, Lin C, Hsieh J, Lan CW, Xiao Y. Efficacy of a multilevel intervention on the mental health of people living with HIV and their family members in rural China. Health Psychol. 2017 Sep;36(9):863-871. doi: 10.1037/hea0000503. Epub 2017 May 22.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Actual Enrollment ICMJE
|Original Estimated Enrollment ICMJE
|Actual Study Completion Date||June 2015|
|Actual Primary Completion Date||June 2015 (Final data collection date for primary outcome measure)|
|Eligibility Criteria ICMJE||
Those who cannot give informed consent (e.g., intoxicated) Those who have a permanent disability (e.g., deaf, serious mental illness, mental retardation).
Anyone who does not meet the inclusion criteria.
|Ages||6 Years and older (Child, Adult, Senior)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||China|
|Removed Location Countries|
|NCT Number ICMJE||NCT01762553|
|Other Study ID Numbers ICMJE||1R01HD068165-01( U.S. NIH Grant/Contract )|
|Has Data Monitoring Committee||Yes|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Li Li, University of California, Los Angeles|
|Study Sponsor ICMJE||University of California, Los Angeles|
|Collaborators ICMJE||Not Provided|
|PRS Account||University of California, Los Angeles|
|Verification Date||February 2016|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP