HIVPhase 1TRACKNCT00429546
Assisting HIV-infected Mothers in Disclosing Their Serostatus to Their Children
A Phase 1 study testing Teaching, Raising, and Communicating with Kids (TRACK) and Treatment as usual in people with HIV, run by University of California, Los Angeles at 1 site in United States.
Trial summary
This study will develop and evaluate the effectiveness of an intervention designed to assist HIV-infected mothers of young children in determining whether and how to appropriately disclose their HIV serostatus to their children. Read more about this study
- Who is it for?
- Ages 6 to 65 years
- Conditions the study is for
- HIV
- What is being tested?
- Teaching, Raising, and Communicating with Kids (TRACK) and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Jan 2010
- Phase
- Phase 1
- 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
- Confirmation of mother's HIV/AIDS status
- Healthy child (i.e., HIV uninfected) who is between 6 and 12 years of age and is unaware of maternal serostatus
- Mother is primary caregiver and child resides with her
- English- or Spanish-speaking
Who cannot join
- Child does not meet screening criteria (e.g., diagnosed with depression or suicide attempt, IQ score less than 75)
- Psychosis of parent or child (as advised by recruitment site clinicians)
- Child refuses to give assent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Los Angeles
Los Angeles, California, 90025
About this study
Official title: Maternal HIV: Intervention to Assist Disclosure to Children
This study will develop and evaluate the effectiveness of an intervention designed to assist HIV-infected mothers of young children in determining whether and how to appropriately disclose their HIV serostatus to their children.
Read the detailed description
HIV is a serious, life threatening illness that requires a lifetime of treatment and disease management. Studies have shown that it can be very difficult for infected mothers to decide whether and/or when to disclose their HIV serostatus to their uninfected children. HIV-infected parents struggle with the fear that their children will be forced to grow up too quickly, become worried or depressed, or be angry with their parents once they learn that their parents have HIV. Family-based intervention programs have been successful in helping facilitate the disclosure process. This study will develop and evaluate the effectiveness of an intervention designed to assist HIV-infected mothers of young children in determining whether and how to appropriately disclose their HIV serostatus to their children.
Participants in this study will be randomly assigned to either the intervention or a standard of care condition. The intervention will consist of three 75-minute sessions that will focus on exploring mothers' concerns, determining children's readiness to receive the news, planning for disclosure, and practicing disclosure. Participants will also receive one follow-up phone call from the therapist about 3 weeks after the last session. Sessions will be scheduled at times that are convenient for the participants and therapists. Follow-up visits will include both mothers and their children, and will be held at Months 3, 6, and 9 following the end of the intervention. Assessments will include readiness to disclose HIV serostatus, mental health indicators, and family functioning.
- Conditions
- HIV
- Being tested
- Teaching, Raising, and Communicating with Kids (TRACK), Treatment as usual
- Keywords
- Disclosure, Serostatus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teaching, Raising, and Communicating with Kids (TRACK)Behavioural
TRACK is cognitive-behavioral treatment designed to improve mother-child communication and parenting skills and prepare caregiver for disclosure of HIV serostatus to child. The treatment consists of three 75-minute sessions that focus on exploring mothers' concerns, determining children's readiness to receive the news, planning for disclosure, and practicing disclosure.
Treatment as usualOther
Treatment as usual includes standard care for HIV infected mothers.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants will receive a cognitive-behavioral intervention designed to improve mother-child communication and parenting skills and prepare caregiver for disclosure of HIV serostatus to child Receives: Behavioral: Teaching, Raising, and Communicating with Kids (TRACK) |
| Control | Active comparator | Participants will receive treatment as usual Receives: Other: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Readiness to disclose HIV serostatus
Measured: Measured at Months 3, 6, and 9
Disclosure of HIV serostatus
Measured: Measured at Months 3, 6, and 9
Secondary outcomes (4)
Mothers' mental health indicators
Measured: Measured at Months 3, 6, and 9
Children's mental health indicators
Measured: Measured at Months 3, 6, and 9
Children's behavioral problems
Measured: Measured at Months 3, 6, and 9
Parent-child relationship and family functioning
Measured: Measured at Months 3, 6, and 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2007 (estimated)
- Study startSep 2007
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 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
- Principal investigator, Debra A. Murphy, Ph.D., University of California, Los Angeles
- Investigators
- Debra A. Murphy, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00429546
- Sponsor's protocol ID
- R01MH077493
- Other IDs
- R01MH077493, DAHBR 9A-ASAP
- Acronym
- TRACK
- Status last verified
- Jun 2013
- First submitted
- 29 Jan 2007
- Last updated
- 26 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal HIV: Intervention to Assist Disclosure to Children
- ClinicalTrials.gov ID
- NCT00429546
- Acronym / sponsor ID
- TRACK / R01MH077493
- Conditions
- HIV
- Keywords
- Disclosure, Serostatus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Sep 2007
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 31 Jan 2007 (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.
This study will develop and evaluate the effectiveness of an intervention designed to assist HIV-infected mothers of young children in determining whether and how to appropriately disclose their HIV serostatus to their children.
Detailed description
HIV is a serious, life threatening illness that requires a lifetime of treatment and disease management. Studies have shown that it can be very difficult for infected mothers to decide whether and/or when to disclose their HIV serostatus to their uninfected children. HIV-infected parents struggle with the fear that their children will be forced to grow up too quickly, become worried or depressed, or be angry with their parents once they learn that their parents have HIV. Family-based intervention programs have been successful in helping facilitate the disclosure process. This study will develop and evaluate the effectiveness of an intervention designed to assist HIV-infected mothers of young children in determining whether and how to appropriately disclose their HIV serostatus to their children.
Participants in this study will be randomly assigned to either the intervention or a standard of care condition. The intervention will consist of three 75-minute sessions that will focus on exploring mothers' concerns, determining children's readiness to receive the news, planning for disclosure, and practicing disclosure. Participants will also receive one follow-up phone call from the therapist about 3 weeks after the last session. Sessions will be scheduled at times that are convenient for the participants and therapists. Follow-up visits will include both mothers and their children, and will be held at Months 3, 6, and 9 following the end of the intervention. Assessments will include readiness to disclose HIV serostatus, mental health indicators, and family functioning.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Teaching, Raising, and Communicating with Kids (TRACK)Participants will receive a cognitive-behavioral intervention designed to improve mother-child communication and parenting skills and prepare caregiver for disclosure of HIV serostatus to child |
| Control | Active comparator | Other: Treatment as usualParticipants will receive treatment as usual |
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)
- Confirmation of mother's HIV/AIDS status
- Healthy child (i.e., HIV uninfected) who is between 6 and 12 years of age and is unaware of maternal serostatus
- Mother is primary caregiver and child resides with her
- English- or Spanish-speaking
Key exclusion criteria (3 listed)
- Child does not meet screening criteria (e.g., diagnosed with depression or suicide attempt, IQ score less than 75)
- Psychosis of parent or child (as advised by recruitment site clinicians)
- Child refuses to give assent
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 |
|---|---|---|
| Teaching, Raising, and Communicating with Kids (TRACK)TRACK is cognitive-behavioral treatment designed to improve mother-child communication and parenting skills and prepare caregiver for disclosure of HIV serostatus to child. The treatment consists of three 75-minute sessions that focus on exploring mothers' concerns, determining children's readiness to receive the news, planning for disclosure, and practicing disclosure. | Behavioural | Intervention |
| Treatment as usualTreatment as usual includes standard care for HIV infected mothers. | Other | Control |
Primary outcome
Readiness to disclose HIV serostatus
Time frame: Measured at Months 3, 6, and 9
Disclosure of HIV serostatus
Time frame: Measured at Months 3, 6, and 9
4 secondary outcomes
Mothers' mental health indicators
Time frame: Measured at Months 3, 6, and 9
Children's mental health indicators
Time frame: Measured at Months 3, 6, and 9
Children's behavioral problems
Time frame: Measured at Months 3, 6, and 9
Parent-child relationship and family functioning
Time frame: Measured at Months 3, 6, and 9
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 26 Jun 2013.
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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.
Debra A. Murphy, PhD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Teaching, Raising, and Communicating with Kids (TRACK) and Treatment as usual 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 3 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 26 Jun 2013. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Readiness to disclose HIV serostatus (time frame: Measured at Months 3, 6, and 9). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jun 2013.