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PRISM Intervention for Tourette Syndrome

(PRISM-TS Trial)

CB
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Overseen ByTouretteAHWFB@Advocatehealth.org
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: Wake Forest University Health Sciences
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This study adapts and tests PRISM (Promoting Resilience in Stress Management), a short skills-based program that teaches resilience, for teens ages 12-18 with Tourette syndrome or persistent tic disorder. The study has three parts. First, a small group of teens and their caregivers try PRISM and give feedback to adapt it for teens with tics. Second, 15 teens complete the adapted program to see whether it is practical and acceptable. Third, 60 teens are randomly assigned to PRISM plus usual care or usual care alone, to see whether a larger trial is feasible and to get early information on resilience and other outcomes.

Who Is on the Research Team?

JM

Jacyln M Martindale, DO

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is for teens ages 12-18 who have Tourette syndrome or a persistent tic disorder. Participants should be able to take part in group sessions and provide feedback about the program.

Inclusion Criteria

I am between 12 and 18 years old.
English fluency in reading and speaking, even as a second language
My tics are moderate to severe based on standard rating scales.
See 3 more

Exclusion Criteria

I have not started any new treatments in the past 8 weeks.
I have a current diagnosis of functional neurological disorder.

What Are the Treatments Tested in This Trial?

Interventions

  • PRISM Intervention

Trial Overview

The study tests PRISM, a short skills-based program that teaches resilience, adapted for teens with tics. Teens are randomly assigned to either receive PRISM plus usual care or just usual care, to see if the program helps and is practical.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Active Control

Group I: Aim 3: PRISM + usual care (n=30)Experimental Treatment1 Intervention
Group II: Aim 2: Open trial (n=15)Experimental Treatment1 Intervention
Group III: Aim 1: Co-adaptation focus group (n=10 + caregivers)Experimental Treatment1 Intervention
Group IV: Aim 3: Usual care (n=30)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials
1,432
Recruited
2,506,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials
3,007
Recruited
2,852,000+

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