NCT00272519

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable hiv-infections

Timeline
Completed

Started Jun 2006

Shorter than P25 for not_applicable hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 3, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 6, 2006

Completed
5 months until next milestone

Study Start

First participant enrolled

June 1, 2006

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
Last Updated

February 28, 2017

Status Verified

February 1, 2016

Enrollment Period

4 months

First QC Date

January 3, 2006

Last Update Submit

February 27, 2017

Conditions

Keywords

HIVAIDSAdolescentHIV Positive

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 year

Secondary Outcomes (1)

  • Evaluate the feasibility and acceptability of an assessment battery

    1 year

Study Arms (1)

Adolescent/caregiver dyads

EXPERIMENTAL

Eight to ten adolescent/caregiver dyads

Behavioral: Life Skills Intervention

Interventions

Developed to promote life skills among young adolescents perinatally infected with HIV

Also known as: No other names.
Adolescent/caregiver dyads

Eligibility Criteria

Age11 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Links

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency SyndromeHIV Seropositivity

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus Diseases

Study Officials

  • Ahna Pai, Ph.D

    Children's Hospital of Philadelphia

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2006

First Posted

January 6, 2006

Study Start

June 1, 2006

Primary Completion

October 1, 2006

Study Completion

October 1, 2006

Last Updated

February 28, 2017

Record last verified: 2016-02

Locations