Trial · NCT07905898
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 23
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Feasibility: Proportion of Participants Completing All Six Core PRISM Sessions (Aim 2) | 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. |
| Primary | Feasibility of Intervention Measure (FIM) Mean Score (Aim 3 PRISM Arm) | 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. |
| Secondary | Feasibility of Intervention Measure (FIM) Mean Score (Aim 2) | Post-intervention (weeks 13-16, about 3-4 months) | 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. |
| Secondary | Acceptability of Intervention Measure (AIM) Score | Post-intervention (weeks 13-16, about 3-4 months) | 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). |
| Secondary | Intervention Appropriateness Measure (IAM) Mean Score | Post-intervention (weeks 13-16, about 3-4 months) | 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). |
| Secondary | Recruitment: Proportion of Eligible Participants Who Consent | At the end of enrollment for each Aim | 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. |
| Secondary | Data Completeness: Proportion of Participants Completing All Study Questionnaires | Baseline, post-intervention (weeks 13-16, about 3-4 months), and week 26 (about 6 months; Aim 3 only) | Proportion of enrolled participants who complete all scheduled self-report questionnaires and clinician-rated assessments at each assessment timepoint. |
| Secondary | Intervention Fidelity: Percentage of PRISM Session Components Delivered | Throughout the intervention period (weeks 1-16, about 4 months) | 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. |
| Secondary | Resilience: Connor-Davidson Resilience Scale-10 (CD-RISC-10) Total Score | Baseline, post-intervention (weeks 13-16, about 3-4 months), and week 26 (about 6 months; Aim 3 only) | 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. |
| Secondary | Tic Severity: Yale Global Tic Severity Scale (YGTSS) Total Tic Severity Score | Baseline, post-intervention (weeks 13-16, about 3-4 months), and week 26 (about 6 months; Aim 3 only) | 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. |
| Secondary | Tic-Related Impairment: Yale Global Tic Severity Scale (YGTSS) Impairment Score | Baseline, post-intervention (weeks 13-16, about 3-4 months), and week 26 (about 6 months; Aim 3 only) | 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. |
| Secondary | Anxiety: PROMIS Pediatric Anxiety Short Form 8a v3.0 Score | Baseline, post-intervention (weeks 13-16, about 3-4 months), and week 26 (about 6 months; Aim 3 only) | 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. |
| Secondary | Depressive Symptoms: PROMIS Pediatric Depressive Symptoms Short Form 8a v3.0 Score | Baseline, post-intervention (weeks 13-16, about 3-4 months), and week 26 (about 6 months; Aim 3 only) | 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. |
| Secondary | Obsessive-Compulsive Symptoms: Children's Florida Obsessive-Compulsive Inventory (C-FOCI) Severity Score | Baseline, post-intervention (weeks 13-16, about 3-4 months), and week 26 (about 6 months; Aim 3 only) | 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. |
| Secondary | ADHD Symptoms: Conners 4 ADHD Index Score | Baseline, post-intervention (weeks 13-16, about 3-4 months), and week 26 (about 6 months; Aim 3 only) | 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 |
| Secondary | Suicide Risk: Number of Participants With a Positive Columbia-Suicide Severity Rating Scale (C-SSRS) Screener | Baseline, post-intervention (weeks 13-16, about 3-4 months), and week 26 (about 6 months; Aim 3 only) | 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. |
| Other | Quality of Life: Gilles de la Tourette Syndrome Quality of Life Scale for Children and Adolescents (C&A-GTS-QOL) Subscale Scores | Baseline, post-intervention (weeks 13-16, about 3-4 months), and week 26 (about 6 months; Aim 3 only) | 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. |
| Other | Stigma: PROMIS Pediatric Stigma Short Form 8a v1.1 Score | Baseline, post-intervention (weeks 13-16, about 3-4 months), and week 26 (about 6 months; Aim 3 only) | 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. |
| Other | Illness Identity: Illness Identity Questionnaire (IIQ) Subscale Scores | Baseline, post-intervention (weeks 13-16, about 3-4 months), and week 26 (about 6 months; Aim 3 only) | 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. |
| Other | Automatic Thoughts: Children's Automatic Thoughts Scale - Negative/Positive (CATS-N/P) Scores | Baseline, post-intervention (weeks 13-16, about 3-4 months), and week 26 (about 6 months; Aim 3 only) | 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. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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