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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00988390
First Posted: October 2, 2009
Last Update Posted: November 28, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of California, Los Angeles
  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: None (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
No Contacts or Locations Provided
  More Information

Publications:
Responsible Party: University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00988390     History of Changes
Other Study ID Numbers: TALKLA-MH068194
5R01MH068194 ( U.S. NIH Grant/Contract )
First Submitted: October 1, 2009
First Posted: October 2, 2009
Last Update Posted: November 28, 2016
Last Verified: November 2016

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
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases