An interventional study of PRISM Intervention and Usual care intervention in Tourette Syndrome, Tic Disorders and Persistent (Chronic) Motor or Vocal Tic Disorder, sponsored by Wake Forest University Health Sciences. Not yet recruiting at 1 site in United States. Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Supportive care
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.
240 studies on the registry are indexed under Tourette Syndrome; 40 are open to participants now.
This study's planned enrollment of 95 is above the median of 36 across 183 interventional studies indexed under Tourette Syndrome.
Browse Tourette Syndrome studies →Wake Forest University Health Sciences is the lead sponsor of 1,351 studies on the registry; 201 are open to participants now.
Of its 332 completed or terminated interventional studies of FDA-regulated products, 251 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PRISM Skills 1-4 (delivered by the PRISM team), each followed by a feedback interview
Behavioral: PRISM Intervention
Adapted PRISM
Behavioral: PRISM Intervention
Adapted PRISM; Usual care
Behavioral: PRISM Intervention
Usual care; study-team check-ins matched to the PRISM schedule
Other: Usual care intervention
One-on-one resilience program: a 10-15 min introductory session, four 30-60 min skills sessions (managing stress, catching thoughts, goal setting, finding the positives), and a 15-45 min family session. Sessions are held every 1-2 weeks, in person or by secure video, with trained research assistants. Biweekly booster check-ins continue through week 16. An optional PRISM app (ages 13+) and worksheets are used for skills practice
Also known as: PRISM, Promoting Resilience in Stress Management
Psychoeducation, medication and/or behavioral therapy as directed by the treating clinician.
Feasibility: Proportion of Participants Completing All Six Core PRISM Sessions (Aim 2)
Feasibility of the adapted PRISM intervention in the Aim 2 open trial, measured as the proportion of participants who complete all six core PRISM sessions (introductory session, four skills sessions, and family session), as recorded on the session attendance log. Feasibility is defined a priori as at least 80% of participants (12 or more of 15) completing all six sessions.
Time frame: Post-intervention (weeks 13-16, about 3-4 months)
Feasibility of Intervention Measure (FIM) Mean Score (Aim 3 PRISM Arm)
Adolescent-rated feasibility of PRISM, measured with the 4-item Feasibility of Intervention Measure (FIM). Each item is rated from 1 (completely disagree) to 5 (completely agree), and the score is the mean of the 4 items (range 1-5). Higher scores indicate greater perceived feasibility. Feasibility is defined a priori as a mean score of 4 or higher. Measured in the Aim 3 PRISM + usual care arm only.
Time frame: Post-intervention (weeks 13-16, about 3-4 months)
Feasibility of Intervention Measure (FIM) Mean Score (Aim 2)
Adolescent-rated feasibility of PRISM in the Aim 2 open trial, measured with the 4-item Feasibility of Intervention Measure (FIM). Each item is rated from 1 (completely disagree) to 5 (completely agree), and the score is the mean of the 4 items (range 1-5). Higher scores indicate greater perceived feasibility.
Time frame: Post-intervention (weeks 13-16, about 3-4 months)
Acceptability of Intervention Measure (AIM) Score
Adolescent-rated acceptability of PRISM, measured with the 4-item Acceptability of Intervention Measure (AIM). Each item is rated from 1 (completely disagree) to 5 (completely agree), and the score is the mean of the 4 items (range 1-5). Higher scores indicate greater acceptability. Measured in participants who receive PRISM (Aim 2 and the Aim 3 PRISM + usual care arm).
Time frame: Post-intervention (weeks 13-16, about 3-4 months)
Intervention Appropriateness Measure (IAM) Mean Score
Adolescent-rated appropriateness (perceived fit and relevance) of PRISM, measured with the 4-item Intervention Appropriateness Measure (IAM). Each item is rated from 1 (completely disagree) to 5 (completely agree), and the score is the mean of the 4 items (range 1-5). Higher scores indicate greater appropriateness. Measured in participants who receive PRISM (Aim 2 and the Aim 3 PRISM + usual care arm).
Time frame: Post-intervention (weeks 13-16, about 3-4 months)
Recruitment: Proportion of Eligible Participants Who Consent
Number of participants who provide informed consent (and assent, if applicable) divided by the number who screen eligible, as recorded on the screening log and enrollment tracker. Reported separately for each Aim.
Time frame: At the end of enrollment for each Aim
Data Completeness: Proportion of Participants Completing All Study Questionnaires
Proportion of enrolled participants who complete all scheduled self-report questionnaires and clinician-rated assessments at each assessment timepoint.
Time frame: Baseline, post-intervention (weeks 13-16, about 3-4 months), and week 26 (about 6 months; Aim 3 only)
Intervention Fidelity: Percentage of PRISM Session Components Delivered
Audio-recorded PRISM sessions are scored by the PRISM team using PRISM's standardized session fidelity checklists, which rate each required session component as covered or not covered. The first 3 sessions and then 1 in 3 randomly selected sessions per interventionist are reviewed. Reported as the mean percentage of checklist components covered across reviewed sessions.
Time frame: Throughout the intervention period (weeks 1-16, about 4 months)
Resilience: Connor-Davidson Resilience Scale-10 (CD-RISC-10) Total Score
10-item adolescent self-report measure of resilience over the past month. Items are rated from 0 (not true at all) to 4 (true nearly all the time) and summed for a total score of 0-40. Higher scores indicate greater resilience. In Aim 3, the between-group difference (PRISM + usual care vs. usual care alone) in change from baseline will be estimated.
Time frame: Baseline, post-intervention (weeks 13-16, about 3-4 months), and week 26 (about 6 months; Aim 3 only)
Tic Severity: Yale Global Tic Severity Scale (YGTSS) Total Tic Severity Score
Clinician-rated, semi-structured interview of tic symptoms over the past week, completed with the adolescent and, for ages 12-17, a parent/caregiver. Motor and phonic tics are each rated on number, frequency, intensity, complexity, and interference (0-5 each), giving a Total Motor score (0-25) and Total Phonic score (0-25), which are summed for a Total Tic Severity score (0-50). Higher scores indicate more severe tics. For participants with persistent motor or vocal tic disorder, the score is capped at 25, and Total Motor and Total Phonic scores are also reported separately. In Aim 3, post-randomization ratings are completed by a blinded assessor.
Time frame: Baseline, post-intervention (weeks 13-16, about 3-4 months), and week 26 (about 6 months; Aim 3 only)
Tic-Related Impairment: Yale Global Tic Severity Scale (YGTSS) Impairment Score
Single clinician rating of overall tic-related impairment over the past week (effects on self-esteem, family life, social acceptance, and school functioning), scored from 0 (none) to 50 (severe) in increments of 10. Higher scores indicate greater impairment. In Aim 3, post-randomization ratings are completed by a blinded assessor.
Time frame: Baseline, post-intervention (weeks 13-16, about 3-4 months), and week 26 (about 6 months; Aim 3 only)
Anxiety: PROMIS Pediatric Anxiety Short Form 8a v3.0 Score
8-item adolescent self-report measure of anxiety symptoms over the past 7 days. Items are rated from 1 (never) to 5 (almost always) and summed for a raw score of 8-40. Higher scores indicate more anxiety symptoms.
Time frame: Baseline, post-intervention (weeks 13-16, about 3-4 months), and week 26 (about 6 months; Aim 3 only)
Depressive Symptoms: PROMIS Pediatric Depressive Symptoms Short Form 8a v3.0 Score
8-item adolescent self-report measure of depressive symptoms over the past 7 days. Items are rated from 1 (never) to 5 (almost always) and summed for a raw score of 8-40. Higher scores indicate more depressive symptoms.
Time frame: Baseline, post-intervention (weeks 13-16, about 3-4 months), and week 26 (about 6 months; Aim 3 only)
Obsessive-Compulsive Symptoms: Children's Florida Obsessive-Compulsive Inventory (C-FOCI) Severity Score
Adolescent self-report measure of obsessive-compulsive symptoms over the past month. Part A is a 17-item yes/no symptom checklist. Part B has 5 severity items (time occupied, distress, difficulty controlling, avoidance, and interference), each rated 0-4 and summed for a severity score of 0-20. Higher scores indicate more severe obsessive-compulsive symptoms.
Time frame: Baseline, post-intervention (weeks 13-16, about 3-4 months), and week 26 (about 6 months; Aim 3 only)
ADHD Symptoms: Conners 4 ADHD Index Score
Adolescent self-report of ADHD symptoms over the past month using the Conners 4 Short Self-Report; items are rated from 0 (not true at all) to 3 (completely true). The ADHD Index is scored according to the Conners 4 manual using age- and sex-based norms. Higher scores indicate a greater likelihood of clinically significant ADHD symptoms
Time frame: Baseline, post-intervention (weeks 13-16, about 3-4 months), and week 26 (about 6 months; Aim 3 only)
Suicide Risk: Number of Participants With a Positive Columbia-Suicide Severity Rating Scale (C-SSRS) Screener
Number of participants with any positive response on the C-SSRS Screener (suicidal ideation items 1-5 or the suicidal behavior item), administered by a trained, certified study team member. Positive screens are also categorized by risk level (low, moderate, high, imminent) under the study's safety triage protocol.
Time frame: Baseline, post-intervention (weeks 13-16, about 3-4 months), and week 26 (about 6 months; Aim 3 only)
Quality of Life: Gilles de la Tourette Syndrome Quality of Life Scale for Children and Adolescents (C&A-GTS-QOL) Subscale Scores
27-item adolescent self-report measure of Tourette-specific health-related quality of life over the past 4 weeks, using the age-appropriate version (6-12 or 13-18 years). Items are rated on a 5-point scale (never to always, scored 0-4). Psychological, physical, obsessional, and cognitive subscale scores are summed and transformed to a 0-100 scale. Higher scores indicate worse quality of life.
Time frame: Baseline, post-intervention (weeks 13-16, about 3-4 months), and week 26 (about 6 months; Aim 3 only)
Stigma: PROMIS Pediatric Stigma Short Form 8a v1.1 Score
8-item adolescent self-report measure of perceived stigma related to the participant's condition over the past 1-2 months. Items are rated from 1 (never) to 5 (always) and summed for a raw score of 8-40. Higher scores indicate greater perceived stigma.
Time frame: Baseline, post-intervention (weeks 13-16, about 3-4 months), and week 26 (about 6 months; Aim 3 only)
Illness Identity: Illness Identity Questionnaire (IIQ) Subscale Scores
25-item adolescent self-report measure of how a chronic condition is integrated into identity, with "my illness" read as "my tic disorder." Items are rated from 1 (strongly disagree) to 5 (strongly agree). Mean scores (range 1-5) are calculated for four subscales: rejection, engulfment, acceptance, and enrichment. Higher rejection and engulfment scores indicate poorer illness integration; higher acceptance and enrichment scores indicate better integration.
Time frame: Baseline, post-intervention (weeks 13-16, about 3-4 months), and week 26 (about 6 months; Aim 3 only)
Automatic Thoughts: Children's Automatic Thoughts Scale - Negative/Positive (CATS-N/P) Scores
50-item adolescent self-report measure of negative and positive self-statements over the past week. Items are rated from 0 (not at all) to 4 (all the time). Four negative subscales (physical threat, social threat, failure, hostility; 0-40 each) are summed for a total negative score (0-160), and a positive thoughts subscale is scored separately (0-40). Higher scores indicate more frequent thoughts of each type.
Time frame: Baseline, post-intervention (weeks 13-16, about 3-4 months), and week 26 (about 6 months; Aim 3 only)
PRISM App Uptake: Number of Participants Who Download the PRISM App
Number of participants who download the optional PRISM skills-practice app, among participants aged 13 and older who receive PRISM (the app license excludes participants under 13).
Time frame: Post-intervention (weeks 13-16, about 3-4 months) and week 26 (about 6 months; Aim 3 only)
PRISM App Engagement: Number of Skills Used in the App
Number of PRISM skills each participant uses in the optional PRISM app, among participants aged 13 and older who receive PRISM
Time frame: Post-intervention (weeks 13-16, about 3-4 months) and week 26 (about 6 months; Aim 3 only)
PRISM App Engagement: Time Spent in the App
Total time (minutes) each participant spends in the optional PRISM app, among participants aged 13 and older who receive PRISM.
Time frame: Post-intervention (weeks 13-16, about 3-4 months) and week 26 (about 6 months; Aim 3 only)
Plan to share: Yes — De-identified individual level data will be shared with the NIMH Data Archive (NDA).
Supporting information: Study protocol
Time frame: Data are expected to remain available in the repository indefinitely unless participants withdraw consent
Access criteria: Available to qualified researchers through the NIMH Data Archive data access request process.
Data sharing details ↗ · nda.nih.gov
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Mar 2031, 52 months later.
Of 65 non-industry interventional studies with no phase under Tourette Syndrome, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 50. This study's planned 52 months is above that.
Counting every sponsor, half of 65 studies reached it within 33 months; a quarter within 22 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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