- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01586988
A Parenting and Self-Care Intervention for HIV Infected Mothers (IMAGE)
November 23, 2016 updated by: University of California, Los Angeles
A Parenting Intervention for HIV+ Moms: The IMAGE Program
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.
Study Overview
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
124
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Los Angeles, California, United States, 90025-7539
- UCLA, Isap
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 65 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
Standard care.
|
|
|
Experimental: IMAGE Intervention
mothers are provided the IMAGE Parenting and Self-Care intervention
|
Mothers in the intervention will receive four individual intervention sessions with a facilitator.
The sessions will cover parenting and self care skills.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Targeted Behaviors, Practices, and Skills and Maternal and Child Health
Time Frame: 3-months, 6-months, and 12-months
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Parenting Self-efficacy
Time Frame: 3-months, 6-months, and 12-months
|
Perceptions of effectiveness in the parental role and general parenting self-efficacy will be assessed.
|
3-months, 6-months, and 12-months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2011
Primary Completion (Actual)
March 1, 2013
Study Completion (Actual)
March 1, 2013
Study Registration Dates
First Submitted
July 1, 2011
First Submitted That Met QC Criteria
April 25, 2012
First Posted (Estimate)
April 27, 2012
Study Record Updates
Last Update Posted (Estimate)
November 28, 2016
Last Update Submitted That Met QC Criteria
November 23, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- R01MH086329 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on HIV
-
Duke UniversityGilead SciencesRecruitingHIV Prevention | HIV Pre-exposure Prophylaxis | HIV Prevention Program | HIV Prevention and Care | HIV Pre-exposure Prophylaxis UseUnited States
-
Federal University of São PauloGilead SciencesCompleted
-
University of Alabama at BirminghamMobile County Health Deparment; Alabama Department of Public HealthRecruitingHIV | HIV Testing | HIV Linkage to Care | HIV TreatmentUnited States
-
Institute of HIV Research and Innovation Foundation...National Institutes of Health (NIH)RecruitingHIV Prevention | PrEP Adherence | HIV Related StigmaThailand
-
University of Alabama at BirminghamNational Institute of Mental Health (NIMH)RecruitingPrEP | HIV | HIV Prevention | PrEP UptakeUnited States
-
ANRS, Emerging Infectious DiseasesNot yet recruitingAntiretroviral Therapy | HIV-1 Infection | HIV Reservoir
-
Massachusetts General HospitalNational Institute of Mental Health (NIMH)RecruitingFeasibility | HIV Prevention | PrEP Uptake | Acceptability | HIV Self-testing | Male Partners of HIV-negative Postpartum WomenSouth Africa
-
ANRS, Emerging Infectious DiseasesHopital Universitaire Robert-Debre; Institut de Recherche pour le Developpement and other collaboratorsUnknownHIV | HIV-uninfected Children | Children Exposed to HIVCameroon
-
French National Agency for Research on AIDS and...Elizabeth Glaser Pediatric AIDS FoundationCompletedPartner HIV Testing | Couple HIV Counseling | Couple Communication | HIV IncidenceCameroon, Dominican Republic, Georgia, India
-
University of MinnesotaWithdrawnHIV Infections | HIV/AIDS | Hiv | AIDS | Aids/Hiv Problem | AIDS and InfectionsUnited States
Clinical Trials on IMAGE Intervention
-
Norwegian School of Sport SciencesUniversity of Tromso; University of Agder; University College of Southeast Norway and other collaboratorsCompletedQuality of Life | Physical Activity | Eating BehaviorsNorway
-
The Miriam HospitalNational Institute on Minority Health and Health Disparities (NIMHD)Completed
-
Texas Tech UniversityCompleted
-
Region ÖstergötlandRecruiting
-
Urological Research Network, LLCRecruitingCancer of the Prostate | Neoplasms ProstateUnited States
-
The Miriam HospitalNational Institute on Minority Health and Health Disparities (NIMHD)Recruiting
-
Liverpool University Hospitals NHS Foundation TrustUniversity of LiverpoolCompletedComplication of Personal Oral HygieneUnited Kingdom
-
Massachusetts General HospitalNational Institute of Mental Health (NIMH); The Fenway InstituteUnknownMedication Adherence | Body Image DisturbanceUnited States
-
Deutsches Herzzentrum MuenchenUnknown
-
Philips Clinical & Medical Affairs GlobalCatharina Ziekenhuis EindhovenCompleted