Transforming Care for Individuals With Childhood-onset Systemic Lupus Erythematosus

Conditions

• Systemic Lupus Erythematosus of Childhood (Disorder)

Eligibility Criteria

Sex

ALL

Age

12 Years - 22 Years

Healthy Volunteers

Not accepted

Interventions

• TEACH — BEHAVIORAL
  TEACH is a cognitive behavioral coping skills program. It consists of six one-hour weekly sessions that are conducted either in-person or remotely.

Study Details

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.

Key Dates

Start date

Sep 12, 2024

Status verified

Oct 2025

Primary completion

Apr 1, 2027

Completion

Sep 30, 2027

Study Design

Enrollment

175 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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.

Primary Outcome Measure

Depressive symptoms, as measured by the Children's Depression Inventory-2 (CDI-2) and Beck Depression Inventory-II (BDI-II) (primary) [ Time Frame: T1 (baseline), T2 (8 weeks), T3 (20 weeks), T4 (32 weeks), T5 (44 weeks), T6 (56 weeks) ]

Central Contacts

• Jocelyn S Zuckerman, BA
  9785051866
  [email protected]
• Natoshia R Cunningham, PhD
  845-662-6198
  [email protected]

Locations (6)

Find similar trials in Birmingham, AL