Family to Family: Psychoeducation to Improve Children's Outcomes in HIV+ Families

NCT01037946 | Completed

• 1 other identifier: R01NR009922
• Study Type: interventional
• Target: 1,033
• Locations: 1 country
• Sites: 1

Brief Summary

This project aims to support adults in HIV-affected families in order to improve their well-being. UCLA's Center for Community Health (CCH), in collaboration with the Thai Ministry of Public Health, Bureau of Epidemiology, will implement the Family-to-Family (F2F) intervention in order to improve the social, behavioral and mental health outcomes for families affected by HIV. In Phase 1, the investigators pilot tested the current intervention contents and activities by collecting qualitative data from HIV+ families in the four district hospitals in Chiang Rai and Nakohn Ratchasima provinces selected for the proposed study. The findings from Phase was used to develop intervention content, as well as the format and style of the intervention for Phase 2. In addition, the findings from Phase 1 was used to finalize the assessment measures the investigators will use in Phase 2. In Phase 2, 410 families with HIV+ parents from 4 district hospitals in Chiang Rai \& Nakhon Ratchasima Provinces will be recruited to an intervention to benefit their school-aged children aged 6-17 years. At their clinical care site,the investigators randomly assigned families to either: 1) F2F, a psychoeducational intervention for HIV+ parents and family caregivers; or 2) a Standard Care condition. The impact of the F2F intervention will be monitored over 24 months.

Conditions

Quality of Life; Family Relations; Mental Health; Physical Health

Keywords

HIV; Family interventions; Thailand

Outcome Measures

Primary Outcomes (1)

• Quality of life

  Assessed up to 24 months

Secondary Outcomes (1)

• Family relations

  Assessed up to 24 months

Study Arms (2)

Standard Care Arm

NO INTERVENTION

Families living with HIV, offered intervention at the end of study (24 months after recruitment)

Intervention

EXPERIMENTAL

Behavioral: Cognitive-behavioral, small group format sessions delivered in Thai to People Living with HIV and their caregivers once a week for 13 weeks (n=13 sessions).

Behavioral: Cognitive behavioral sessions

Interventions

Cognitive behavioral sessions BEHAVIORAL

Behavioral: Cognitive-behavioral, small group format sessions delivered in Thai to People Living with HIV and their caregivers once a week for 13 weeks (n=13 sessions).

Also known as: Intervention, families living with HIV

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV+ or family member of HIV+ person
• living with one or more school-age children aged 12-17;
• Informed consent;
• Disclosure of serostatus to at least one family member

You may not qualify if:

• No school-age children living at home; or
• No disclosure of the serostatus to any family member; or
• Inability to give informed consent or refusal

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA

Los Angeles, California, 90024, United States

Location

MeSH Terms

Conditions

Psychological Well-Being

Interventions

Methods; Seroconversion

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques; Immune System Phenomena

Study Officials

• Li Li, Ph.D.

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

• Sam Guo, MBA

  University of California, Los Angeles

  STUDY DIRECTOR

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

Study Record Dates

• First Submitted: December 22, 2009
• First Posted: December 23, 2009
• Study Start: September 1, 2005
• Primary Completion: December 1, 2009
• Study Completion: May 1, 2010
• Last Updated: February 24, 2012

Record last verified: 2009-06

Locations

US (1)