TEA for Families and Children: A Randomized Intervention Trial

NCT01762553 | Completed DMC

• 1 other identifier: 1R01HD068165-01
• Study Type: interventional
• Target: 1,533
• Locations: 1 country
• Sites: 1

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.

Conditions

Behaviors; Health

Outcome Measures

Primary Outcomes (1)

• children's behavior problems and health

  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).

  Change from baseline to 6-, 12-, 18-, and 24 month follow up

Secondary Outcomes (1)

• People living with HIV and Family member

  Change from baseline to 6-. 12-, 18-, and 24 month follow up

Study Arms (2)

intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

The TEA intervention BEHAVIORAL

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.

intervention

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• PLH: age 18 or over, being a resident of one of the 24 selected villages, who is currently HIV sero-positive parent of a child between 6-18 years in his/her family, and who provide informed consent.
• Family members: 18 years and older, being a resident of one of the 24 selected villages, who is aware of PLH's HIV status, who has consent from participating PLH to be invited to join the study, and who provides informed consent. If there are two PLHs in a household, they both will be recruited as PLH participants.
• Children: aged 6-18 years, being a resident of one of the 24 selected villages, who lives in a HIV-affected family in which at least one or both parents is HIV-positive, and who provides parent/guardian permission, child/youth assent forms or informed consent if aged 18.

You may not qualify if:

• Those who cannot give informed consent (e.g., intoxicated) Those who have a permanent disability (e.g., deaf, serious mental illness, mental retardation).

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

Anhui Provincial Center for Disease Control and Prevention

Hefei, Anhui, China

Location

Related Publications (2)

• Li L, Liang LJ, Lin C, Lan CW, Ji G, Xiao Y. Changes in behavioral outcomes among children affected by HIV: Results of a randomized controlled trial in China. J Health Psychol. 2019 Sep;24(11):1581-1594. doi: 10.1177/1359105317746479. Epub 2017 Dec 15.

  PMID: 29243519 DERIVED

• 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.

  PMID: 28530433 DERIVED

MeSH Terms

Conditions

Behavior

Study Officials

• Li Li, PhD

  NPI-Center for Community Health, UCLA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Residence

Study Record Dates

• First Submitted: January 4, 2013
• First Posted: January 7, 2013
• Study Start: May 1, 2011
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: February 18, 2016

Record last verified: 2016-02

Locations

CN (1)