TEA for Families and Children: A Randomized Intervention Trial
|ClinicalTrials.gov Identifier: NCT01762553|
Recruitment Status : Completed
First Posted : January 7, 2013
Last Update Posted : February 18, 2016
|Condition or disease||Intervention/treatment||Phase|
|Behaviors Health||Behavioral: The TEA intervention||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1533 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||TEA (Together for Empowerment Activities)for Families and Children: A Randomized Intervention Trial|
|Study Start Date :||May 2011|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||June 2015|
The TEA intervention program will be implemented for the intervention group. The TEA intervention has three modules (healthy body & healthy mind, family interaction, and quality of life) logically connected to each other and implemented at three levels from individual, family to the community: 1) TEA Gathering is a small group training session for PLH and their family members to deal with HIV-related challenges at individual level; 2) 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; 3) 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.
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.
No Intervention: Control
In order to tease out the impact of the proposed intervention from the impact of attention in general, we will add limited activities to the control group condition. The differences between the intervention and control conditions consist in both contents and formats. For the control group, there will only be group sessions once a week for three weeks starting after baseline assessment. The content of the sessions for the control group will focus on basic care, health education and promotion, nutrition, personal and family hygiene. The Essential Care Package (ECP), a set of education materials originally developed by the World Health Organization (WHO) and supported by the Global Fund Project, will be used and explained in these group sessions. Health workers from villages in the control group will also visit participating families once a week for the initial three weeks and once a month for 12 months.
- 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).
- 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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01762553
|Anhui Provincial Center for Disease Control and Prevention|
|Hefei, Anhui, China|
|Principal Investigator:||Li Li, PhD||NPI-Center for Community Health, UCLA|