HIVIMAGENCT01586988
A Parenting and Self-Care Intervention for HIV Infected Mothers
A study testing IMAGE Intervention in people with HIV, run by University of California, Los Angeles at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 6 to 65 years
- Conditions the study is for
- HIV
- What is being tested?
- IMAGE Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Mar 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- low cognitive/intellectual functioning (<75) in mother or child
- psychosis in mother or child
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- HIV
- Being tested
- IMAGE Intervention
- Keywords
- HIV, Parenting, self-care, disclosure, medication adherence, mother, child, adolescent
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMAGE InterventionBehavioural
Mothers in the intervention will receive four individual intervention sessions with a facilitator. The sessions will cover parenting and self care skills.
| Study group | Role | What they receive |
|---|---|---|
| IMAGE Intervention | Experimental | mothers are provided the IMAGE Parenting and Self-Care intervention Receives: Behavioral: IMAGE Intervention |
| Control | No intervention | Standard care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3-months, 6-months, and 12-months
Secondary outcomes (1)
Parenting Self-efficacy
Perceptions of effectiveness in the parental role and general parenting self-efficacy will be assessed.
Measured: 3-months, 6-months, and 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2012 (estimated)
- Study startFeb 2011
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01586988
- Sponsor's protocol ID
- R01MH086329
- Other IDs
- R01MH086329
- Acronym
- IMAGE
- Status last verified
- Nov 2016
- First submitted
- 1 Jul 2011
- Last updated
- 28 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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. doi: 10.1080/09540121.2016.1204416. Epub 2016 Jul 4.
PubMed 27377577
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Parenting Intervention for HIV+ Moms: The IMAGE Program
- ClinicalTrials.gov ID
- NCT01586988
- Acronym / sponsor ID
- IMAGE / R01MH086329
- Conditions
- HIV
- Keywords
- HIV, Parenting, self-care, disclosure, medication adherence, mother, child, adolescent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Feb 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 27 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IMAGE Intervention | Experimental | Behavioral: IMAGE Interventionmothers are provided the IMAGE Parenting and Self-Care intervention |
| Control | No intervention | –Standard care. |
Who may qualify
- Ages
- 6 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- low cognitive/intellectual functioning (<75) in mother or child
- psychosis in mother or child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMAGE InterventionMothers in the intervention will receive four individual intervention sessions with a facilitator. The sessions will cover parenting and self care skills. | Behavioural | IMAGE Intervention |
Primary outcome
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.
1 secondary outcome
Parenting Self-efficacy
Time frame: 3-months, 6-months, and 12-months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2016.
- Results publication: PubMed 27377577Murphy 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. doi: 10.1080/09540121.2016.1204416. Epub 2016 Jul 4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IMAGE Intervention in people with HIV, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Targeted Behaviors, Practices, and Skills and Maternal and Child Health (time frame: 3-months, 6-months, and 12-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01586988, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2016.