BehaviorsNCT01762553
TEA for Families and Children: A Randomized Intervention Trial
A study testing The TEA intervention in people with Behaviors and Health, run by University of California, Los Angeles at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 6 years and older
- What is being tested?
- The TEA intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,533 participants
- Where
- 1 siteChina
- Study dates
- May 2011to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Anhui Provincial Center for Disease Control and Prevention
Hefei, Anhui
About this study
Official title: TEA (Together for Empowerment Activities)for Families and Children: A Randomized Intervention Trial
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.
Read the detailed 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:
- 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.
- 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.
- 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.
- Being tested
- The TEA intervention
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The TEA interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Change from baseline to 6-, 12-, 18-, and 24 month follow up
Secondary outcomes (1)
People living with HIV and Family member
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).
Measured: Change from baseline to 6-. 12-, 18-, and 24 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2013 (estimated)
- Study startMay 2011
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for BehaviorsStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,533 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Li, University of California, Los Angeles
- Investigators
- Li Li, PhD, Principal investigator, NPI-Center for Community Health, UCLA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01762553
- Sponsor's protocol ID
- 1R01HD068165-01
- Status last verified
- Feb 2016
- First submitted
- 4 Jan 2013
- Last updated
- 18 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 29243519Li 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.
PubMed 28530433
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TEA (Together for Empowerment Activities)for Families and Children: A Randomized Intervention Trial
- ClinicalTrials.gov ID
- NCT01762553
- Acronym / sponsor ID
- 1R01HD068165-01
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,533 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 7 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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:
- 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.
- 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.
- 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Behavioral: The TEA interventionThe 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. |
| 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. |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The TEA interventionTEA 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. | Behavioural | intervention |
Primary outcome
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).
1 secondary outcome
People living with HIV and Family member
Time frame: Change from baseline to 6-. 12-, 18-, and 24 month follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2016.
- Derived from this study: PubMed 29243519Li 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.
- Derived from this study: PubMed 28530433Li 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.
Related trials for Behaviors
Recruiting
The Trans-Led Care Study
Substance Abuse, Substance Addiction
Active, not recruitingPhase 2
Effects of Brain Stimulation on Food Intake and Behavioral Weight Loss Treatment
Electric Stimulation Therapy, Obesity
Enrolling by invitation
Neural Mechanisms for Stopping Ongoing Speech Production (Study 2)
Epilepsy, Speech
Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
Familial Hypercholesterolemia
Recruiting
Neurobehavioral Changes Following Spaceflight Stressors
Stressor, Individual, Alcohol Impairment
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li Li, PhD principal investigator
NPI-Center for Community Health, UCLA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The TEA intervention in people with Behaviors and Health, run by University of California, Los Angeles at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
children's behavior problems and health (time frame: Change from baseline to 6-, 12-, 18-, and 24 month follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01762553, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2016.