Complete Cognitive Intervention for cSLE

NCT ID: NCT07302113

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2027-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Lupus

Keywords

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lupus psychological intervention adolescent cognitive

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TOPS

Group Type EXPERIMENTAL

Lupus Teen Online Problem Solving program

Intervention Type BEHAVIORAL

The Lupus Teen Online Problem Solving program is a brain health intervention developed to meet the needs of youth with childhood-onset lupus. The original Teen Online Problem Solving Program (TOPS) was developed for use with families impacted by traumatic brain injury. The Lupus Teen Online Problem Solving program is based on TOPS, with modifications to maximize relevance and accessibility. The intervention is a 10 session, evidence-based telehealth program providing training in problem-solving, emotion regulation, and communication skills in a one-to-one therapist-mediated design.

Interventions

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Lupus Teen Online Problem Solving program

The Lupus Teen Online Problem Solving program is a brain health intervention developed to meet the needs of youth with childhood-onset lupus. The original Teen Online Problem Solving Program (TOPS) was developed for use with families impacted by traumatic brain injury. The Lupus Teen Online Problem Solving program is based on TOPS, with modifications to maximize relevance and accessibility. The intervention is a 10 session, evidence-based telehealth program providing training in problem-solving, emotion regulation, and communication skills in a one-to-one therapist-mediated design.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.)
Minimum Eligible Age

13 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Hospital for Sick Children

OTHER

Sponsor Role collaborator

Andrea Knight

OTHER

Sponsor Role lead

Responsible Party

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Andrea Knight

Clinical Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Busi Zapparoli, PhD

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children

Andrea Knight, MD, MSCE

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children

Central Contacts

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Busi Zapparoli, PhD

Role: CONTACT

Phone: (416) 813-7654

Email: [email protected]

Other Identifiers

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3413

Identifier Type: -

Identifier Source: org_study_id