RECRUITING

Transforming Care for Individuals with Childhood-onset Systemic Lupus Erythematosus

Conditions

Systemic Lupus Erythematosus of Childhood (Disorder)lupus depression depressive symptoms fatigue pain SLE rheumatic disease rheumatology cognitive behavioral Childhood-onset Systemic Lupus Erythematosus cSLE Implementation Coping skills Mindfulness

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-09-12

Study Completion:2027-09-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06232304

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years to 22 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion Criteria
* 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 (i.e., ≥10 on the PHQ-9), 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	* 1) other chronic medical conditions (e.g., juvenile arthritis) * 2) a documented developmental delay, severe cognitive impairment, or thought disorder * 3) an untreated major psychiatric illness (e.g., bipolar disorder, psychosis, severe depression (score ≥20) or active suicidal ideation (SI), based on the Pediatric Health Questionnaire (PHQ-9) items plus clinical interview; see Measures section)

Inclusion Criteria

Exclusion Criteria

* 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 (i.e., ≥10 on the PHQ-9), 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

* 1) other chronic medical conditions (e.g., juvenile arthritis)
* 2) a documented developmental delay, severe cognitive impairment, or thought disorder
* 3) an untreated major psychiatric illness (e.g., bipolar disorder, psychosis, severe depression (score ≥20) or active suicidal ideation (SI), based on the Pediatric Health Questionnaire (PHQ-9) items plus clinical interview; see Measures section)

Contacts and Locations

Study Contact

Jocelyn S Zuckerman, BA

CONTACT

9785051866

zucker32@msu.edu

Natoshia R Cunningham, PhD

CONTACT

845-662-6198

natoshia@msu.edu

Principal Investigator

Natoshia R Cunningham, PhD

PRINCIPAL_INVESTIGATOR

Michigan State University

Andrea Knight, MD, MSCE

PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children

Study Locations (Sites)

University of Alabama Birmingham Hospital

Birmingham, Alabama, 35233

United States

Children's Hospital of New Orleans/ Tulane University

New Orleans, Louisiana, 70118

United States

Helen Devos Children's Hospital

Grand Rapids, Michigan, 49503

United States

Montefiore Medical Center

Bronx, New York, 10467

United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229

United States

Seattle Children's Hospital

Seattle, Washington, 98105

United States

Collaborators and Investigators

Sponsor: Michigan State University

Natoshia R Cunningham, PhD, PRINCIPAL_INVESTIGATOR, Michigan State University
Andrea Knight, MD, MSCE, PRINCIPAL_INVESTIGATOR, The Hospital for Sick Children

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-12

Study Completion Date2027-09-30

Study Record Updates

Study Start Date2024-09-12

Study Completion Date2027-09-30

Terms related to this study

Keywords Provided by Researchers

lupus
depression
depressive symptoms
fatigue
pain
SLE
rheumatic disease
rheumatology
cognitive behavioral
Childhood-onset Systemic Lupus Erythematosus
cSLE
Implementation
Coping skills
Mindfulness

Additional Relevant MeSH Terms

Systemic Lupus Erythematosus of Childhood (Disorder)