Complete Cognitive Intervention for cSLE (CCIC)

Andrea Knight

Status: Not yet enrolling

Conditions: Lupus

Treatments: Behavioral: Lupus Teen Online Problem Solving program

Study type: Interventional

Funder types: Other

Identifiers

NCT07302113

3413

Details and patient eligibility

About

This project will work closely with patients to design and test a new program that supports brain health in children and youth with childhood-onset lupus (cSLE). The investigators will see how practical and helpful the program is for patients.

Full description

The proposed project will use a patient-informed participatory action approach to develop and assess preliminary feasibility and acceptability of an intervention tailored to address the specific brain health needs of cSLE patients.

Enrollment: 60 estimated patients

Sex: All

Ages: 13 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Receive subject-informed consent;
• Have a current diagnosis of cSLE that meets the 1997 American College of Rheumatology (ACR) or System Lupus International Collaborating Clinics (SLICC) classification criteria
• Aged 13-18 years old

Exclusion criteria

• Conditions that significantly affect cognition (e.g., intellectual disability diagnosis, active psychosis), hearing loss or vision problems precluding participation in group
• Non-English speaking
• Lack of access to technology that would allow them to participate in the virtual intervention (e.g., phone, tablet, computer, etc.)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

60 participants in 1 patient group

TOPS

Experimental group

Treatment:

Behavioral: Lupus Teen Online Problem Solving program