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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00988390
Other study ID # TALKLA-MH068194
Secondary ID 5R01MH068194
Status Completed
Phase N/A
First received October 1, 2009
Last updated November 23, 2016
Start date February 2005
Est. completion date June 2008

Study information

Verified date November 2016
Source University of California, Los Angeles
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 543
Est. completion date June 2008
Est. primary completion date June 2008
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

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).

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
University of California, Los Angeles National Institute of Mental Health (NIMH)

References & Publications (1)

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. — View Citation

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