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

Primary Purpose

Family Relations, Mental Health, Physical Health

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cognitive-behavioral, small-group format sessions
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Family Relations focused on measuring mothers living with HIV, family intervention, family functioning, conflict, Mental health, and physical health, Family relationships (functioning and conflict)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Other

    No Intervention

    No Intervention

    Arm Label

    Intervention, mothers living with HIV

    Control, mothers living with HIV

    Control, non-HIV-infected mothers

    Arm Description

    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)

    Mothers living with HIV, offered intervention at end of study (18 months after recruitment)

    Neighborhood control mothers not infected with HIV, did not receive any intervention

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    October 1, 2009
    Last Updated
    November 23, 2016
    Sponsor
    University of California, Los Angeles
    Collaborators
    National Institute of Mental Health (NIMH)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00988390
    Brief Title
    Mothers Living With HIV and Their Adolescent Children
    Acronym
    TALK LA
    Official Title
    Mothers Living With HIV and Their Adolescent Children
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2005 (undefined)
    Primary Completion Date
    June 2008 (Actual)
    Study Completion Date
    June 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of California, Los Angeles
    Collaborators
    National Institute of Mental Health (NIMH)

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Family Relations, Mental Health, Physical Health, Risky Sexual Behavior, Substance Use, HIV Infections
    Keywords
    mothers living with HIV, family intervention, family functioning, conflict, Mental health, and physical health, Family relationships (functioning and conflict)

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    543 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention, mothers living with HIV
    Arm Type
    Other
    Arm Description
    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)
    Arm Title
    Control, mothers living with HIV
    Arm Type
    No Intervention
    Arm Description
    Mothers living with HIV, offered intervention at end of study (18 months after recruitment)
    Arm Title
    Control, non-HIV-infected mothers
    Arm Type
    No Intervention
    Arm Description
    Neighborhood control mothers not infected with HIV, did not receive any intervention
    Intervention Type
    Behavioral
    Intervention Name(s)
    Cognitive-behavioral, small-group format sessions
    Intervention Description
    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).

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    22020758
    Citation
    Rotheram-Borus MJ, Rice E, Comulada WS, Best K, Elia C, Peters K, Li L, Green S, Valladares E. Intervention outcomes among HIV-affected families over 18 months. AIDS Behav. 2012 Jul;16(5):1265-75. doi: 10.1007/s10461-011-0075-z.
    Results Reference
    result

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    Mothers Living With HIV and Their Adolescent Children

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