Tourette SyndromePRISM-TSNCT07905898
Evaluating and Promoting Resilience in Adolescents With Tourette Syndrome
A study testing PRISM Intervention in people with Tourette Syndrome and Tic Disorders, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Tourette Syndrome, Tic Disorders, Persistent (Chronic) Motor or Vocal Tic Disorder
- What is being tested?
- PRISM Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to Jun 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 12-18 years
- Physician-confirmed diagnosis of Tourette syndrome or persistent (chronic) motor or vocal tic disorder per DSM-5-TR criteria
- YGTSS Total Tic Severity ≥15 (Tourette syndrome) or Total Motor/Total Phonic score ≥10 (persistent motor or vocal tic disorder)
- YGTSS Impairment ≥20
- English fluency in reading and speaking, even as a second language
- Able to understand and complete study procedures and measures
Who cannot join
- An active diagnosis of functional neurological disorder
- Beginning any new therapy within 8 weeks of study initiation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
TouretteAHWFB@Advocatehealth.org contact
United States1 site
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157
Carolina Burgos-Aguilar, MS, 336-713-2603, Carolina.Burgosaguilar@advocatehealth.org
TouretteAHWFB@Advocatehealth.org
About this study
Official title: Adapting and Pilot Testing Promoting Resilience in Stress Management (PRISM) for Adolescents With Tourette Syndrome and Persistent Tic Disorders: A Mixed-Methods Feasibility Study and Pilot Randomized Controlled 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.
Read the detailed description
- Rationale Resilience, the ability to adapt positively to adversity, may improve the ability of adolescents to cope with psychosocial distress even when tics persist. Resilience is a modifiable protective factor that can mitigate negative outcomes while facilitating positive ones. Evidence-based resilience skills across several relevant populations - including ADHD, learning disabilities, and depression (all prevalent co-occurring conditions of TS) - associate resilience with better psychosocial adjustment, life satisfaction, hope and benefit finding, Quality of Life (QOL), coping, and mental health outcomes. No current therapies for TS systematically teach resilience. Thus, a skills-based intervention focusing on strengthening resilience may improve psychosocial distress and TS-related outcomes.
- The intervention Promoting Resilience in Stress Management (PRISM) is a brief, skills-based resilience intervention developed using the Transactional Model of Stress and Coping and the NIH ORBIT model. It teaches four skills (managing stress, catching thoughts, goal setting, and finding the positives) through six one-on-one sessions with a trained interventionist. An optional app supports skills practice. PRISM has been adapted for adolescents and young adults with cancer, type 1 diabetes, cystic fibrosis, chronic pain, and other conditions. It has not yet been adapted or tested for Tourette syndrome.
- Overall design This mixed-methods study enrolls 85 adolescents ages 12-18 with Tourette syndrome or persistent tic disorder at Wake Forest University School of Medicine/Atrium Health Wake Forest Baptist. It runs in three sequential phases. The intervention is adapted with input from teens and caregivers (Aim 1), tested in a single-arm open trial (Aim 2), and then evaluated in a pilot randomized controlled trial against usual care (Aim 3). The PRISM package is finalized before Aim 3 enrollment begins and does not change during the pilot trial.
- Aim 1: Co-adaptation Ten adolescents and their caregivers take part in five virtual focus group sessions. In Sessions 1-4, the PRISM team delivers one PRISM skill per session. Teens and caregivers then give feedback in separate semi-structured interviews, guided by the MODIFI adaptation framework. In Session 5, teens complete and give feedback on the proposed survey measures. The qualitative findings guide revisions to PRISM module names, manual text, examples, worksheets, and training materials. The core skills and the app are not changed.
- Aim 2: Open trial Fifteen adolescents receive the adapted PRISM: six sessions held every 1-2 weeks, in person or by video, followed by biweekly booster check-ins through week 16. The primary outcome is feasibility, defined in advance as at least 80% of participants completing all six sessions. Acceptability and appropriateness are measured with validated implementation measures (FIM, AIM, IAM), along with fidelity and app use. Post-intervention interviews with teens and caregivers explore barriers and facilitators. The findings are used to refine PRISM before Aim 3.
- Aim 3: Pilot randomized controlled trial Sixty adolescents are randomized 1:1 to PRISM plus usual care or usual care alone, stratified by YGTSS tic impairment. Usual-care participants receive study-team check-ins matched in number and timing to the PRISM sessions. Assessments occur at baseline, post-intervention (weeks 13-16), and week 26, and post-randomization clinician ratings are done by a blinded assessor. The primary outcome is feasibility: a mean FIM score of 4 or higher in the PRISM arm. Secondary outcomes include resilience (CD-RISC-10), tic severity and impairment, co-occurring symptoms, quality of life, stigma, illness identity, and automatic thoughts. Results will inform the design and sample size of a future fully powered efficacy trial.
- Being tested
- PRISM Intervention, Usual care intervention
- Keywords
- Tics, Resilience, Psychosocial Distress, Adolescents, Stigma, Quality of life, PRISM
- Medical subject headings
- Tourette Syndrome, Tic Disorders, Bronchiolitis Obliterans Syndrome, Tics, Social Stigma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRISM InterventionBehavioural
Also called PRISM, Promoting Resilience in Stress Management
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
Usual care interventionOther
Psychoeducation, medication and/or behavioral therapy as directed by the treating clinician.
| Study group | Role | What they receive |
|---|---|---|
| Aim 1: Co-adaptation focus group (n=10 + caregivers) | Other | PRISM Skills 1-4 (delivered by the PRISM team), each followed by a feedback interview Receives: Behavioral: PRISM Intervention |
| Aim 2: Open trial (n=15) | Experimental | Adapted PRISM Receives: Behavioral: PRISM Intervention |
| Aim 3: PRISM + usual care (n=30) | Experimental | Adapted PRISM; Usual care Receives: Behavioral: PRISM Intervention |
| Aim 3: Usual care (n=30) | Active comparator | Usual care; study-team check-ins matched to the PRISM schedule Receives: Other: Usual care intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Post-intervention (weeks 13-16, about 3-4 months)
Secondary outcomes (14)
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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: Baseline, post-intervention (weeks 13-16, about 3-4 months), and week 26 (about 6 months; Aim 3 only)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionMar 2031 (estimated)
- Study completionJun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tourette SyndromeStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 95 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Jacyln M Martindale, DO, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07905898
- Sponsor's protocol ID
- IRB00158033
- Other IDs
- 1K23MH141319-01A1
- Acronym
- PRISM-TS
- Status last verified
- Oct 2026
- First submitted
- 23 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual level data will be shared with the NIMH Data Archive (NDA).
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapting and Pilot Testing Promoting Resilience in Stress Management (PRISM) for Adolescents With Tourette Syndrome and Persistent Tic Disorders: A Mixed-Methods Feasibility Study and Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07905898
- Acronym / sponsor ID
- PRISM-TS / IRB00158033
- Keywords
- Tics, Resilience, Psychosocial Distress, Adolescents, Stigma, Quality of life, PRISM
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 95 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Nov 2026 (estimated)
- Primary completion
- Mar 2031 (estimated)
- Study completion
- Jun 2031 (estimated)
- First posted
- 30 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- Rationale Resilience, the ability to adapt positively to adversity, may improve the ability of adolescents to cope with psychosocial distress even when tics persist. Resilience is a modifiable protective factor that can mitigate negative outcomes while facilitating positive ones. Evidence-based resilience skills across several relevant populations - including ADHD, learning disabilities, and depression (all prevalent co-occurring conditions of TS) - associate resilience with better psychosocial adjustment, life satisfaction, hope and benefit finding, Quality of Life (QOL), coping, and mental health outcomes. No current therapies for TS systematically teach resilience. Thus, a skills-based intervention focusing on strengthening resilience may improve psychosocial distress and TS-related outcomes.
- The intervention Promoting Resilience in Stress Management (PRISM) is a brief, skills-based resilience intervention developed using the Transactional Model of Stress and Coping and the NIH ORBIT model. It teaches four skills (managing stress, catching thoughts, goal setting, and finding the positives) through six one-on-one sessions with a trained interventionist. An optional app supports skills practice. PRISM has been adapted for adolescents and young adults with cancer, type 1 diabetes, cystic fibrosis, chronic pain, and other conditions. It has not yet been adapted or tested for Tourette syndrome.
- Overall design This mixed-methods study enrolls 85 adolescents ages 12-18 with Tourette syndrome or persistent tic disorder at Wake Forest University School of Medicine/Atrium Health Wake Forest Baptist. It runs in three sequential phases. The intervention is adapted with input from teens and caregivers (Aim 1), tested in a single-arm open trial (Aim 2), and then evaluated in a pilot randomized controlled trial against usual care (Aim 3). The PRISM package is finalized before Aim 3 enrollment begins and does not change during the pilot trial.
- Aim 1: Co-adaptation Ten adolescents and their caregivers take part in five virtual focus group sessions. In Sessions 1-4, the PRISM team delivers one PRISM skill per session. Teens and caregivers then give feedback in separate semi-structured interviews, guided by the MODIFI adaptation framework. In Session 5, teens complete and give feedback on the proposed survey measures. The qualitative findings guide revisions to PRISM module names, manual text, examples, worksheets, and training materials. The core skills and the app are not changed.
- Aim 2: Open trial Fifteen adolescents receive the adapted PRISM: six sessions held every 1-2 weeks, in person or by video, followed by biweekly booster check-ins through week 16. The primary outcome is feasibility, defined in advance as at least 80% of participants completing all six sessions. Acceptability and appropriateness are measured with validated implementation measures (FIM, AIM, IAM), along with fidelity and app use. Post-intervention interviews with teens and caregivers explore barriers and facilitators. The findings are used to refine PRISM before Aim 3.
- Aim 3: Pilot randomized controlled trial Sixty adolescents are randomized 1:1 to PRISM plus usual care or usual care alone, stratified by YGTSS tic impairment. Usual-care participants receive study-team check-ins matched in number and timing to the PRISM sessions. Assessments occur at baseline, post-intervention (weeks 13-16), and week 26, and post-randomization clinician ratings are done by a blinded assessor. The primary outcome is feasibility: a mean FIM score of 4 or higher in the PRISM arm. Secondary outcomes include resilience (CD-RISC-10), tic severity and impairment, co-occurring symptoms, quality of life, stigma, illness identity, and automatic thoughts. Results will inform the design and sample size of a future fully powered efficacy trial.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Aim 1: Co-adaptation focus group (n=10 + caregivers) | Other | Behavioral: PRISM InterventionPRISM Skills 1-4 (delivered by the PRISM team), each followed by a feedback interview |
| Aim 2: Open trial (n=15) | Experimental | Behavioral: PRISM InterventionAdapted PRISM |
| Aim 3: PRISM + usual care (n=30) | Experimental | Behavioral: PRISM InterventionAdapted PRISM; Usual care |
| Aim 3: Usual care (n=30) | Active comparator | Other: Usual care interventionUsual care; study-team check-ins matched to the PRISM schedule |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Age 12-18 years
- Physician-confirmed diagnosis of Tourette syndrome or persistent (chronic) motor or vocal tic disorder per DSM-5-TR criteria
- YGTSS Total Tic Severity ≥15 (Tourette syndrome) or Total Motor/Total Phonic score ≥10 (persistent motor or vocal tic disorder)
- YGTSS Impairment ≥20
- English fluency in reading and speaking, even as a second language
Key exclusion criteria (2 listed)
- An active diagnosis of functional neurological disorder
- Beginning any new therapy within 8 weeks of study initiation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRISM InterventionAlso: PRISM, Promoting Resilience in Stress ManagementOne-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 | Behavioural | Aim 1: Co-adaptation focus group (n=10 + caregivers), Aim 2: Open trial (n=15), Aim 3: PRISM + usual care (n=30) |
| Usual care interventionPsychoeducation, medication and/or behavioral therapy as directed by the treating clinician. | Other | Aim 3: Usual care (n=30) |
Primary outcome
Feasibility: Proportion of Participants Completing All Six Core PRISM Sessions (Aim 2)
Time frame: Post-intervention (weeks 13-16, about 3-4 months)
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.
Feasibility of Intervention Measure (FIM) Mean Score (Aim 3 PRISM Arm)
Time frame: Post-intervention (weeks 13-16, about 3-4 months)
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.
14 secondary outcomes
Feasibility of Intervention Measure (FIM) Mean Score (Aim 2)
Time frame: Post-intervention (weeks 13-16, about 3-4 months)
Acceptability of Intervention Measure (AIM) Score
Time frame: Post-intervention (weeks 13-16, about 3-4 months)
Intervention Appropriateness Measure (IAM) Mean Score
Time frame: Post-intervention (weeks 13-16, about 3-4 months)
Recruitment: Proportion of Eligible Participants Who Consent
Time frame: At the end of enrollment for each Aim
Data Completeness: Proportion of Participants Completing All Study Questionnaires
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
Time frame: Throughout the intervention period (weeks 1-16, about 4 months)
Resilience: Connor-Davidson Resilience Scale-10 (CD-RISC-10) Total Score
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
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
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
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
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
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
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
Time frame: Baseline, post-intervention (weeks 13-16, about 3-4 months), and week 26 (about 6 months; Aim 3 only)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified individual level data will be shared with the NIMH Data Archive (NDA).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
TouretteAHWFB@Advocatehealth.org contact
Jacyln M Martindale, DO principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRISM Intervention in people with Tourette Syndrome and Tic Disorders, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carolina Burgos-Aguilar, MS (336.713.2603, Carolina.Burgosaguilar@advocatehealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility: Proportion of Participants Completing All Six Core PRISM Sessions (Aim 2) (time frame: Post-intervention (weeks 13-16, about 3-4 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.