TEA for Families and Children: A Randomized Intervention Trial

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by University of California, Los Angeles
Sponsor:
Information provided by (Responsible Party):
Li Li, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01762553
First received: January 4, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
  Purpose

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.


Condition Intervention
Behaviors
Health
Behavioral: The TEA intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: TEA (Together for Empowerment Activities)for Families and Children: A Randomized Intervention Trial

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • children's behavior problems and health [ Time Frame: Change from baseline to 6-, 12-, 18-, and 24 month follow up ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • People living with HIV and Family member [ Time Frame: Change from baseline to 6-. 12-, 18-, and 24 month follow up ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 1680
Study Start Date: May 2011
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: intervention
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01762553

Contacts
Contact: Li Li 310-794-2446 lililili@ucla.edu

Locations
China, Anhui
Anhui Provincial Center for Disease Control and Prevention Recruiting
Hefei, Anhui, China
Contact: Guoping Ji, PhD         
Principal Investigator: Guoping Ji, PhD         
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: Li Li, PhD NPI-Center for Community Health, UCLA
  More Information

No publications provided

Responsible Party: Li Li, Professor in Residence, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01762553     History of Changes
Other Study ID Numbers: 1R01HD068165-01
Study First Received: January 4, 2013
Last Updated: January 4, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 22, 2014