Mothers Living With HIV and Their Adolescent Children (TALK LA)

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00988390
First received: October 1, 2009
Last updated: October 14, 2009
Last verified: October 2009
  Purpose
  • Context: Mothers living with HIV (MLH) and their children face predictable challenges: maintaining physical and mental health, parenting while ill, and addressing HIV-related stressors.
  • Objective: To evaluate the efficacy of a family-based intervention over time; to contrast the life adjustments of HIV-affected families and their non-HIV-affected neighbors in the current treatment era.
  • Design: Randomized controlled trial of MLH and a longitudinal comparison of MLH to a neighborhood cohort using random effect regression.
  • Participants and Intervention: MLH (n = 339) and their school-age children (n = 259) were randomly assigned to receive 1) an intervention of 16 sessions in a cognitive-behavioral, small-group format; or 2) control. MLH and their children were compared to non-HIV-affected families recruited at shopping markets. Participant retention was high: 84% at 6 months, 83% at 12 months, and 78% at 18 months.
  • Main Outcome Measures: Family functioning and conflict, mental and physical health, sexual behavior, and substance use.

Condition Intervention
Family Relations
Mental Health
Physical Health
Risky Sexual Behavior
Substance Use
HIV Infections
Behavioral: Cognitive-behavioral, small-group format sessions

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Mothers Living With HIV and Their Adolescent Children

Resource links provided by NLM:


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

Enrollment: 543
Study Start Date: February 2005
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Intervention, mothers living with HIV
Mothers living with HIV, Cognitive-behavioral intervention delivered in either English- or Spanish-speaking groups of 5 to 8 mothers living with HIV twice weekly for 1.5 to 2 hours each over eight weeks (n = 16 sessions)
Behavioral: Cognitive-behavioral, small-group format sessions
The intervention was delivered in either English- or Spanish-speaking groups of 5 to 8 mothers living with HIV twice weekly for 1.5 to 2 hours each over eight weeks (n = 16 sessions).
No Intervention: Control, mothers living with HIV
Mothers living with HIV, offered intervention at end of study (18 months after recruitment)
No Intervention: Control, non-HIV-infected mothers
Neighborhood control mothers not infected with HIV, did not receive any intervention

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria for Intervention/Control, mother living with HIV:

  • Mother or primary female caregiver
  • Enrolled in HIV-related clinical cares
  • At least one child between the age of 6 and 20 years

Inclusion Criteria for neighborhood control, non-HIV-affected mother:

  • Mother or primary female caregiver
  • not HIV-positive
  • At least one child between the age of 6 and 20 years

Exclusion Criteria (Intervention/Control/Neighborhood):

  • Mother less than 18 years old
  • Unable or willing to give informed consent
  • Psychosis or neurological damage as judged by the investigator in consultation with clinical supervisor
  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.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Mary Jane Rotheram-Borus, Ph.D. / Director, UCLA Center for Community Health
ClinicalTrials.gov Identifier: NCT00988390     History of Changes
Other Study ID Numbers: TALKLA-MH068194, 5R01MH068194
Study First Received: October 1, 2009
Last Updated: October 14, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:
mothers living with HIV
family intervention
family functioning
conflict
Mental health
and physical health
Family relationships (functioning and conflict)

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on August 26, 2014