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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01586988
Other study ID # R01MH086329
Secondary ID R01MH086329
Status Completed
Phase N/A
First received July 1, 2011
Last updated November 23, 2016
Start date February 2011
Est. completion date March 2013

Study information

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

Clinical Trial Summary

The IMAGE intervention was developed to improve parenting and self-care skills in mothers infected with HIV. It is expected that an improvement in these areas will in turn improve the mother's physical and mental health as well as the child's mental health and behavioral adjustment.


Description:

Worldwide, close to half the adults living with HIV are women and a large proportion of these women are of child-bearing age. Whereas anyone living with HIV faces the physical challenges of living with a chronic disease, as well as the material and social impact of the stigma associated with the disease, mothers living with HIV must also meet the demands of childrearing while mitigating the negative impact of the disease upon their family. Mothers with HIV report that this is their greatest source of stress. Moreover, children of these mothers, growing up with a parent with a chronic, stigmatized, and often fatal disease, are considered a high-risk group. The IMAGE intervention was designed to improve parenting and self-care skills in mothers with HIV in order to improve the mother's physical and mental health as well as the child's mental health and behavioral adjustment.


Recruitment information / eligibility

Status Completed
Enrollment 124
Est. completion date March 2013
Est. primary completion date March 2013
Accepts healthy volunteers No
Gender Both
Age group 6 Years to 65 Years
Eligibility Inclusion Criteria:

- mother has confirmed diagnosis of HIV

- well (HIV-) child, 6 to 14 years of age

- mother is English or Spanish speaking

- child is English speaking

Exclusion Criteria:

- low cognitive/intellectual functioning (<75) in mother or child

- psychosis in mother or child

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)


Related Conditions & MeSH terms


Intervention

Behavioral:
IMAGE Intervention
Mothers in the intervention will receive four individual intervention sessions with a facilitator. The sessions will cover parenting and self care skills.

Locations

Country Name City State
United States UCLA, Isap Los Angeles California

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

References & Publications (1)

Murphy DA, Armistead L, Payne DL, Marelich WD, Herbeck DM. Pilot trial of a parenting and self-care intervention for HIV-positive mothers: the IMAGE program. AIDS Care. 2017 Jan;29(1):40-48. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Targeted Behaviors, Practices, and Skills and Maternal and Child Health Specific targets of the intervention, including parenting practices, parenting behaviors, and self care skills, will be evaluated. In addition, the mother's physical and mental health and the child's mental health and behavioral adjustment will be evaluated. 3-months, 6-months, and 12-months No
Secondary Parenting Self-efficacy Perceptions of effectiveness in the parental role and general parenting self-efficacy will be assessed. 3-months, 6-months, and 12-months No
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