HIV InfectionsNCT00272519
Life Skills Intervention for Adolescents Perinatally Infected With HIV
A study testing Life Skills Intervention in people with HIV Infections, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The life skills intervention model is designed to help adolescents promote their physical and mental health through cognitive and behavioral techniques (e.g., problem solving, coping, and communication skills) designed to help them achieve social and personal competencies used to manage various life challenges. Read more about this study
- Who is it for?
- Ages 11 to 14 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Life Skills Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Oct 2006
- 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 11 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Clinically-identified HIV-1 infected participants 11-14 years of age and their primary caregivers.
- HIV status has been disclosed to the adolescent.
- Caregiver is the legal guardian of the adolescent as indicated by the medical team.
- Adolescent lives with the caregiver
- Adolescent and caregiver speak and understand English.
Who cannot join
- Caregiver consent or permission denied or adolescent does not assent.
- Adolescent diagnosed as mentally retarded as previously reported or confirmed through chart review.
- Adolescent and/or caregiver too medically fragile. Medically fragile is functionally defined as being physically unable to attend the group.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: Life Skills Intervention for Young Adolescents Perinatally Infected With HIV and Their Caregivers
The life skills intervention model is designed to help adolescents promote their physical and mental health through cognitive and behavioral techniques (e.g., problem solving, coping, and communication skills) designed to help them achieve social and personal competencies used to manage various life challenges.
Read the detailed description
One of the salient advantages of this intervention model is that it has been developed and implemented in several studies with adolescents. However, data concerning the effects of this model are much less extensive with adolescents perinatally infected with HIV. The proposed study is designed to address this gap in knowledge by conducting a pilot intervention tailoring the life skills intervention to the needs of young adolescents, perinatally infected with HIV, and to their primary caregivers. Given the emphasis on peer group interaction, the proposed intervention model also has the potential to reduce some of the social isolation imposed by the experiences related to HIV infection by creating opportunities for adolescents to interact with others who are managing comparable stressors and treatment regimens.
- Conditions
- HIV Infections
- Being tested
- Life Skills Intervention
- Keywords
- HIV, AIDS, Adolescent, HIV Positive
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome, HIV Seropositivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Life Skills InterventionBehavioural
Also called No other names.
Developed to promote life skills among young adolescents perinatally infected with HIV
| Study group | Role | What they receive |
|---|---|---|
| Adolescent/caregiver dyads | Experimental | Eight to ten adolescent/caregiver dyads Receives: Behavioral: Life Skills Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implement and evaluate the feasibility and acceptability of a modified life skills intervention
To implement and evaluate the feasibility and acceptability of a modified life skills intervention for young adolescents with perinatally acquired HIV infection and their primary caregivers.
Measured: 1 year
Secondary outcomes (1)
Evaluate the feasibility and acceptability of an assessment battery
To evaluate the feasibility and acceptability of an assessment battery with young adolescents with perinatally acquired HIV infection and their primary caregivers when implemented at baseline, post-intervention and 4-month follow-up.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2006 (estimated)
- Study startJun 2006
- Primary completionOct 2006
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH), National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Ahna Pai, Ph.D, Study chair, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00272519
- Sponsor's protocol ID
- ATN 045b
- Status last verified
- Feb 2016
- First submitted
- 3 Jan 2006
- Last updated
- 28 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Life Skills Intervention for Young Adolescents Perinatally Infected With HIV and Their Caregivers
- ClinicalTrials.gov ID
- NCT00272519
- Acronym / sponsor ID
- ATN 045b
- Conditions
- HIV Infections
- Keywords
- HIV, AIDS, Adolescent, HIV Positive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH), National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Jun 2006
- Primary completion
- Oct 2006 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 6 Jan 2006 (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 life skills intervention model is designed to help adolescents promote their physical and mental health through cognitive and behavioral techniques (e.g., problem solving, coping, and communication skills) designed to help them achieve social and personal competencies used to manage various life challenges.
Detailed description
One of the salient advantages of this intervention model is that it has been developed and implemented in several studies with adolescents. However, data concerning the effects of this model are much less extensive with adolescents perinatally infected with HIV. The proposed study is designed to address this gap in knowledge by conducting a pilot intervention tailoring the life skills intervention to the needs of young adolescents, perinatally infected with HIV, and to their primary caregivers. Given the emphasis on peer group interaction, the proposed intervention model also has the potential to reduce some of the social isolation imposed by the experiences related to HIV infection by creating opportunities for adolescents to interact with others who are managing comparable stressors and treatment regimens.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adolescent/caregiver dyads | Experimental | Behavioral: Life Skills InterventionEight to ten adolescent/caregiver dyads |
Who may qualify
- Ages
- 11 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Clinically-identified HIV-1 infected participants 11-14 years of age and their primary caregivers.
- HIV status has been disclosed to the adolescent.
- Caregiver is the legal guardian of the adolescent as indicated by the medical team.
- Adolescent lives with the caregiver
- Adolescent and caregiver speak and understand English.
Key exclusion criteria (3 listed)
- Caregiver consent or permission denied or adolescent does not assent.
- Adolescent diagnosed as mentally retarded as previously reported or confirmed through chart review.
- Adolescent and/or caregiver too medically fragile. Medically fragile is functionally defined as being physically unable to attend the group.
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 |
|---|---|---|
| Life Skills InterventionAlso: No other names.Developed to promote life skills among young adolescents perinatally infected with HIV | Behavioural | Adolescent/caregiver dyads |
Primary outcome
Implement and evaluate the feasibility and acceptability of a modified life skills intervention
Time frame: 1 year
To implement and evaluate the feasibility and acceptability of a modified life skills intervention for young adolescents with perinatally acquired HIV infection and their primary caregivers.
1 secondary outcome
Evaluate the feasibility and acceptability of an assessment battery
Time frame: 1 year
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 Feb 2017.
- Website for the Adolescent Trials Network for HIV/AIDS InterventionsLink provided by the sponsor.
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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.
Ahna Pai, Ph.D study chair
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Life Skills Intervention in people with HIV Infections, run by University of North Carolina, Chapel Hill 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 5 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 28 Feb 2017. 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?
Implement and evaluate the feasibility and acceptability of a modified life skills intervention (time frame: 1 year). 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 28 Feb 2017.