Transforming Behavioral Healthcare to Improve the Quality of Life for Individuals With Childhood-onset Lupus

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This study aims to investigate the feasibility and effectiveness of a cognitive behavioral coping skills program, Treatment and Education Approach for Childhood-onset Lupus (TEACH), for youth with cSLE when integrated into medical care. This TEACH program aims to teach participants skills in order to cope with fatigue, pain, and depressive symptoms--symptoms that commonly affect adolescents and young adults with lupus.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 22
Healthy Volunteers: f
View:

• 1\) be diagnosed with cSLE, meeting the revised American College of Rheumatology Classification Criteria for SLE by age 18 years

• 2\) be between the ages of 12 and 22 years

• 3\) in recognition of the heterogeneity of cSLE symptoms, have elevations in fatigue (i.e., T scores ≥60; or at least moderate symptoms, on the PROMIS measure) OR depressive symptoms (≥5 on the PHQ-9, T Score ≥ 60 on the BDI or CDI II ), OR pain (i.e., average pain ≥3 out of 10 on the Pain VAS)

• 4\) have English language proficiency (their primary caregiver can have English or Spanish language proficiency for the child to enroll)

• 5\) those under age 18 years (US), or 16 years (Canada) must have a consenting caregiver

Locations
United States
Alabama
University of Alabama Birmingham Hospital
RECRUITING
Birmingham
Louisiana
Children's Hospital of New Orleans/ Tulane University
RECRUITING
New Orleans
Michigan
Helen Devos Children's Hospital
RECRUITING
Grand Rapids
New York
Montefiore Medical Center
RECRUITING
The Bronx
Ohio
Cincinnati Children's Hospital Medical Center
RECRUITING
Cincinnati
Washington
Seattle Children's Hospital
RECRUITING
Seattle
Other Locations
Canada
The Hospital for Sick Children
RECRUITING
Toronto
Contact Information
Primary
Jocelyn S Zuckerman, BA
zucker32@msu.edu
9785051866
Backup
Natoshia R Cunningham, PhD
natoshia@msu.edu
845-662-6198
Time Frame
Start Date: 2024-09-12
Estimated Completion Date: 2027-09-30
Participants
Target number of participants: 175
Treatments
Experimental: TEACH
Participants will undergo a cognitive behavioral coping skills program and continue medical treatment as usual.
No_intervention: Control
Participants will only continue medical treatment as usual.
Related Therapeutic Areas
Sponsors
Collaborators: Helen DeVos Children's Hospital, United States Department of Defense, Seattle Children's Hospital, Tulane University, Children's Hospital Medical Center, Cincinnati, Montefiore Medical Center, University of Alabama at Birmingham, The Hospital for Sick Children
Leads: Michigan State University

This content was sourced from clinicaltrials.gov