Recruiting

PREP-Y

Sponsor:

William Black

Code:

NCT07049029

Conditions

Chronic Pain

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Not accepted

Interventions

PREP-Y

Study Details

Brief summary:

The purpose of this research study is to test a new program called Pain REsilience Promotion for Youth (PREP-Y). This program is designed to help adolescents with chronic musculoskeletal pain (pain in muscles, bones, or joints that lasts more than 3 months) become more physically active and better able to manage their pain. The program includes four weekly virtual sessions that teach skills related to resilience, such as how to stay motivated, build confidence, and cope with pain.

Participants will complete surveys and physical activity tests before and after the program. Participants will also wear physical activity monitors to track their activity levels. The goal of this study is to learn whether the program is practical, helpful, and acceptable to participants, and to prepare for a future larger study.

Conditions

Chronic Pain

Study ID

NCT07049029

Start date

Sep 29, 2025

Status verified date

Jun, 2025

Completion date

Dec 1, 2026

Anticipated

Primary completion date

Oct 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Between the ages of 12 and 17
  • History of chronic musculoskeletal pain for more than 3 months assessed by a pediatric rheumatologist or pain physician
  • Diagnosis of a primary pain disorder (e.g., juvenile fibromyalgia and other widespread pain conditions, lower back pain, complex regional pain and amplified pain syndrome)
  • Speaks English as primary language

Exclusion Criteria:

  • Chronic pain secondary to disease (e.g., sickle cell disease or rheumatic disease such as juvenile arthritis, systemic lupus erythematosus)
  • Presence of an untreated major psychiatric diagnosis (e.g., major depression, bi-polar disorder, psychoses)
  • History or diagnosis of developmental delay.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: PREP-Y

Interventions

PREP-Y

The intervention is a series of behavioral health/psychoeducational modules that the participant will learn from. Participants will use the information discussed and overall impact on physical activity engagement, chronic pain management, and quality of life will be measured

Primary outcome measure

  • Feasibility of Intervention [ Time Frame: From enrollment to the post-treatment visit, for a total of 6 weeks ]
  • Acceptability of Intervention [ Time Frame: From enrollment to the post-treatment visit, for a total of 6 weeks ]

Central Contacts and Locations

Central contacts

Locations

Nationwide Children's Hospital

Recruiting

Columbus, Ohio, United States, 43205

Contacts

More Information

Sponsor

William Black

Last update posted

Oct 3, 2025

Last verified

Jun, 2025

Keywords

  • Chronic Pain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by William Black on 2025-10-03.