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

October 1, 2009
October 14, 2009
February 2005
June 2008   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00988390 on ClinicalTrials.gov Archive Site
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Not Provided
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Mothers Living With HIV and Their Adolescent Children
Mothers Living With HIV and Their Adolescent Children
  • 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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Family Relations
  • Mental Health
  • Physical Health
  • Risky Sexual Behavior
  • Substance Use
  • HIV Infections
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).
  • 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)
    Intervention: Behavioral: Cognitive-behavioral, small-group format 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
543
June 2008
June 2008   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00988390
TALKLA-MH068194, 5R01MH068194
No
Mary Jane Rotheram-Borus, Ph.D. / Director, UCLA Center for Community Health
University of California, Los Angeles
National Institute of Mental Health (NIMH)
Not Provided
University of California, Los Angeles
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP