Chronic Tic DisorderNCT04678180
Treatment Outcome of Combined Virtual Tic Training in Children and Adolescents With a Chronic Tic Disorder
A study testing Combined HRT and ERP in people with Chronic Tic Disorder, run by Aarhus University Hospital at 1 site in Denmark.
Trial summary
Tics are unwanted, repetitive movements or sounds that are either simple or complex in appearance. Tic disorders often have a huge impact on children's life. The investigators have previously shown a positive outcome of tic training combining habit reversal training (HRT) and exposure response prevention (ERP) either… Read more about this study
- Who is it for?
- Ages 9 to 17 years
- Conditions the study is for
- Chronic Tic Disorder
- What is being tested?
- Combined HRT and ERP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2021to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 9 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
None listed.
Who cannot join
- Comorbidity including
- Mental retardering
- Psychosis
- Severe depression
- Suicidal behavior
- Severe anorexia or
- If they have participated in tic training with HRT and/or ERP during the last 6 months
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of child and adolescent Psychiatry, Aarhus University Hospital
Aarhus, 8240
About this study
Official title: Randomized Clinical Study Evaluating the Treatment Outcome of Combined Virtual Tic Training in Children and Adolescents With a Chronic Tic Disorder
Tics are unwanted, repetitive movements or sounds that are either simple or complex in appearance. Tic disorders often have a huge impact on children's life. The investigators have previously shown a positive outcome of tic training combining habit reversal training (HRT) and exposure response prevention (ERP) either as an individual therapy or in a group setting. However, young people and families are often busy, and having to use a full day as to attend to tic training often is difficult both for the young person and their families. Therefore, the present study focuses on the clinical outcome of combining virtual training with training at the hospital
Read the detailed description
Tics are unwanted, brief, repetitive, non-rhythmic movements or sounds that are classified as either simple or complex. Dependent on duration, tics are divided into transient tics and chronic tics. Tic disorders often have an early age of onset and may have a major impact on a young person's life. Treatment of a chronic tic disorder primarily comprises therapeutic intervention which consists of ERP (Exposure Response Prevention) and/or HRT (Habit Reversal Training).
The purpose of the project is to
- Evaluate the treatment outcome of combined video consultation/participating in training sessions at the hospital and of combined self-instructed video training/participating in training sessions at the hospital.
- Compare the treatment outcome of supplementary virtual consultation and supplementary video training via an app with a previous study on the treatment outcome of attending individual therapy (NISSEN, 2018) by means of benchmarking.
- In addition, expound on the significance of sensory modulation (sensitivity), not-just-right experience and the child's perception with regard to the severity of chronic tics and treatment outcome. Also, to investigate whether insight, sensitivity and the not-just-right experience change during treatment.
- As the app is newly developed in relation to the present study, the investigators wish to clarify the participants' evaluation of the app using a newly developed questionnaire (designed for this project). For comparison, a questionnaire has been designed for evaluating the applicability of the supplementary video sessions.
When patients are referred to the Tourette outpatient clinic, Aarhus University Hospital, Psychiatry, a comprehensive diagnostic assessment is carried out. The assessment is based on a modified version of the Schedule for affective disorders and schizophrenia for school-age children - present and lifetime version (K-SADS-PL). The K-SADS-PL information is used for confirming the primary diagnosis of chronic tics and for ensuring that none of the exclusion criteria have been met.
Inclusion criteria
The inclusion criteria are defined based on the ICD-10 diagnosis (International Classification of Diseases and Related Health Problems):
Chronic motor/vocal tics (DF95.1) Tourette syndrome (DF95.2), Age spectrum: 9-17 years old
Exclusion criteria
The exclusion criteria are defined as follows:
Patients with comorbidity such as mental retardation (IQ = 70 or less), psychosis, severe depression requiring treatment, suicidal behavior/threats or severe eating disorder.
Participated in tics training based on HRT/ERP treatment within the last six months.
Oral and written consent will be obtained from parents and children/adolescents (age 15 years and older).
The study will be an open, randomized controlled clinical study for children and adolescents with chronic tics disorders. The participants will be randomized using computer-generated randomization based on age and sex.
The participants will either be randomized for tics training with attendance combined with virtual training (group 1) or a combination of attendance and self-instructed training via videos on an app (group 2). Both settings are based on the "Niks til Tics" manual (NISSEN, 2018) that describes training in Habit Reversal Training (HRT) and Exposure Response Prevention (ERP) over nine sessions. Thus, two treatment groups will be set up:
Group 1 (treatment group 1) will consist of nine entire sessions (60 min each), but where four out of the nine sessions will be converted to video consultations. The content of the video consultations is comparable to the information and training the patients would have received if they attended at the clinic and which are defined in the "Niks til Tics" manual.
Group 2 (treatment group 2) will comprise five entire sessions (60 min) with clinic attendance, but where sessions 1 and 2 will be combined into one session with a duration of 120 min, session 4 will be held as usual with attendance after five weeks, session 8 will be held ten weeks after session 4, and session 9 will be held after two months. In addition, patients in group 2 will be given the opportunity to talk to the therapist on the phone. For the group 2 training sessions, an app has been developed for teaching patients the tics training method. A new app session will be released at each new treatment session, and the content of the app videos will follow the information and training, which the patients would have received if they had attended at the clinic and which are defined in the "Niks til Tics" manual.
All tic training sessions will be individual. The primary outcome goal includes the Yale Global Tics Severity Scale (YGTSS) in session 8. In order to follow the treatment, a parent report questionnaire and a self-report questionnaire will be used and evaluated in accordance with YGTSS (Golden standard). The questionnaires are based on Parent Tic Questionnaire (PTQ). Secondary outcome measures are Screen for Child Anxiety Related Emotional Disorders (SCARED), the Mood and Feelings Questionnaire (MFQ), Premonitory Urge Scale (PUTS), Beliefs About Tics Scale (BATS), NJR-C (not just right experiences), CATS (thoughts about experiences children may be exposed to), W-tc (worrying thoughts) and motivation questionnaire, and the parents are asked to fill in CBCL, BQ (general information) as well as a sensory profile (about hypersensitivity).
Statistical analyses The primary analysis will comprise a comparison of effect sizes within the treatment group, that is, an assessment of the reduction in tic intensity during the eight sessions. The difference in tic intensity between baseline and session 8 will be assessed at t-test. Effect sizes will be calculated by a ratio of the mean difference and the standard deviation of the difference between baseline and session 8 (SD diff). The confidence interval for effect sizes will be calculated using non-parametric bootstrap with 100 replications. At group sizes of 30 with an expected uniform YGTSS baseline of 25 (randomized) and with an expected SD of 6.2 (from a previous study (NISSEN 2018)), and a strength of 0.8 it should be possible to detect a decrease of point 3.4 (from baseline to session 8), which is statistically significant.
Responder level will be defined as a 25% reduction of the YGTSS total tics score.
The secondary analyses will study the reduction in tic intensity between the two treatment groups using unpaired t-test. At a group size of 30 and expected end YGTSS of 15 (SD 6.2) and strength of 0.80 (from a previous study (NISSEN 2018)), a difference of 4.6 between the two groups will be statistically significant.
Predictor analysis: baseline characteristics and baseline tic severity between the two groups will be compared using univariate Chi test for categorical variables and t-tests for continuous variables.
Tic severity will be assessed by independent raters.
Using benchmarking, the results of this treatment study will be compared with the results from a previous treatment study on HRT/ERP (NISSEN, 2018).
- Conditions
- Chronic Tic Disorder
- Being tested
- Combined HRT and ERP
- Keywords
- Habit reversal training, Exposure response prevention, Children and adolescents, virtual training
- Medical subject headings
- Tic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined HRT and ERPBehavioural
tic training using the principles of HRT and ERP as to reduce tic intensity
| Study group | Role | What they receive |
|---|---|---|
| Virtual tic training | Experimental | A combination of treatment using virtual tic training and training at the hospital. In total nine sessions using a combined training of HRT and ERP. In four of the nine sessions (session 3, 5, 6, 7) training is performed as a virtual training. All sessions last 60 minutes Receives: Behavioral: Combined HRT and ERP |
| Video tic training | Experimental | A combination of treatment using self-instructive videos and training at the hospital. In total nine sessions using a combined training of HRT and ERP. Four of the nine sessions are completed at the hospital (session 1 and 2 are combined 120 minutes, session 4: 60 minutes, session 8: 60 minutes and session 9: 60 minutes). For all sessions, self-instructive videos have been recorded instructing the child and their families how they should perform the training Receives: Behavioral: Combined HRT and ERP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of baseline Yale Global Tic Severity Scale (YGTSS) at 16 weeks, 24 weeks, 40 weeks, 68 weeks
YGTSS - a clinician-administered semi-structured interview including a checklist of all tics present in the past week. It covers five dimensions divided into ten items including the number, frequency, intensity, complexity and interference of motor and vocal tics. Furthermore, it includes a separate evaluation of the functional impairment. Measures the change in total tic score and functional impairment. Interval 0-100, high score means a worse outcome
Measured: Baseline,16 weeks, 24 weeks, 40 weeks, 68 weeks
Secondary outcomes (3)
Change of baseline Premonitory Urge Scale (PUTS) 6 weeks, 16 weeks, 24 weeks, 40 weeks, 68 weeks
PUTS is a short self-reporting scale with nine items. It measures the tic-related premonitory urge. Measures the change of baseline premonitory urge score at different end points. Interval 1-4, high score means a worse outcome
Measured: Baseline, 6 weeks, 16 weeks, 24 weeks, 40 weeks, 68 weeks
Change of baseline Beliefs About Tics Scale (BATS) at 6 weeks, 16 weeks, 24 weeks, 40 weeks, 68 weeks
BATS is a self-reporting scale with 20 items developed to assess the different beliefs children and adolescent experience in relation to tic symptoms and to suppressing their tic symptoms. Measures the change of baseline premonitory urge score at different end points. Interval 1-4, high score means a worse outcome
Measured: Baseline, 6 weeks, 16 weeks, 24 weeks, 40 weeks, 68 weeks
Change of baseline Parent and child self-evaluating questionnaire at 16 weeks, 24 weeks, 40 weeks, 68 weeks
Based on the PTQ a self-evaluating questionnaire have been developed for the children and their parents. Interval 1-4, high score means a worse outcome. The results will be compared to the golden standard YGTSS
Measured: Baseline,16 weeks, 24 weeks, 40 weeks, 68 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study start1 Jan 2021
- Primary completion30 Apr 2022
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Chronic Tic DisorderStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group 1: a combination of treatment using virtual training (secure interactive video training) and training at the hospital. In total, nine sessions using a combined training of HRT and ERP Group 2: a combination of treatment using self-instructive videos and training at the hospital. In total, nine sessions using a combined training of HRT and ERP
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Judith Becker Nissen, Aarhus University Hospital
- Investigators
- Judith Nissen, phd, Principal investigator, Department of Child and Adolescent Psychiatry, Aarhus University Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04678180
- Sponsor's protocol ID
- 1-10-72-231-20
- Status last verified
- Feb 2024
- First submitted
- 9 Dec 2020
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abramovitch A, Reese H, Woods DW, Peterson A, Deckersbach T, Piacentini J, Scahill L, Wilhelm S. Psychometric Properties of a Self-Report Instrument for the Assessment of Tic Severity in Adults With Tic Disorders. Behav Ther. 2015 Nov;46(6):786-96. doi: 10.1016/j.beth.2015.06.002. Epub 2015 Jun 18.
PubMed 26520221Andren P, Aspvall K, Fernandez de la Cruz L, Wiktor P, Romano S, Andersson E, Murphy T, Isomura K, Serlachius E, Mataix-Cols D. Therapist-guided and parent-guided internet-delivered behaviour therapy for paediatric Tourette's disorder: a pilot randomised controlled trial with long-term follow-up. BMJ Open. 2019 Feb 15;9(2):e024685. doi: 10.1136/bmjopen-2018-024685.
PubMed 30772854Birmaher B, Brent DA, Chiappetta L, Bridge J, Monga S, Baugher M. Psychometric properties of the Screen for Child Anxiety Related Emotional Disorders (SCARED): a replication study. J Am Acad Child Adolesc Psychiatry. 1999 Oct;38(10):1230-6. doi: 10.1097/00004583-199910000-00011.
PubMed 10517055Leckman JF, Riddle MA, Hardin MT, Ort SI, Swartz KL, Stevenson J, Cohen DJ. The Yale Global Tic Severity Scale: initial testing of a clinician-rated scale of tic severity. J Am Acad Child Adolesc Psychiatry. 1989 Jul;28(4):566-73. doi: 10.1097/00004583-198907000-00015.
PubMed 2768151Neal M, Cavanna AE. "Not just right experiences" in patients with Tourette syndrome: complex motor tics or compulsions? Psychiatry Res. 2013 Dec 15;210(2):559-63. doi: 10.1016/j.psychres.2013.06.033. Epub 2013 Jul 10.
PubMed 23850205Nissen JB, Kaergaard M, Laursen L, Parner E, Thomsen PH. Combined habit reversal training and exposure response prevention in a group setting compared to individual training: a randomized controlled clinical trial. Eur Child Adolesc Psychiatry. 2019 Jan;28(1):57-68. doi: 10.1007/s00787-018-1187-z. Epub 2018 Jun 28.
PubMed 29956034Ricketts EJ, Goetz AR, Capriotti MR, Bauer CC, Brei NG, Himle MB, Espil FM, Snorrason I, Ran D, Woods DW. A randomized waitlist-controlled pilot trial of voice over Internet protocol-delivered behavior therapy for youth with chronic tic disorders. J Telemed Telecare. 2016 Apr;22(3):153-62. doi: 10.1177/1357633X15593192. Epub 2015 Jul 13.
PubMed 26169350Singer HS. Tics and Tourette Syndrome. Continuum (Minneap Minn). 2019 Aug;25(4):936-958. doi: 10.1212/CON.0000000000000752.
PubMed 31356288Steinberg T, Harush A, Barnea M, Dar R, Piacentini J, Woods D, Shmuel-Baruch S, Apter A. Tic-related cognition, sensory phenomena, and anxiety in children and adolescents with Tourette syndrome. Compr Psychiatry. 2013 Jul;54(5):462-6. doi: 10.1016/j.comppsych.2012.12.012. Epub 2013 Jan 15.
PubMed 23332555Wood A, Kroll L, Moore A, Harrington R. Properties of the mood and feelings questionnaire in adolescent psychiatric outpatients: a research note. J Child Psychol Psychiatry. 1995 Feb;36(2):327-34. doi: 10.1111/j.1469-7610.1995.tb01828.x.
PubMed 7759594Woods DW, Piacentini J, Himle MB, Chang S. Premonitory Urge for Tics Scale (PUTS): initial psychometric results and examination of the premonitory urge phenomenon in youths with Tic disorders. J Dev Behav Pediatr. 2005 Dec;26(6):397-403. doi: 10.1097/00004703-200512000-00001.
PubMed 16344654ACHENBACH TM. Child behavior checklist and related instruments. In The use of psychological testing for treatment planning and outcome assessment. Edited by Maurish ME. Hillsdale, NJ: Lawrence Erlbaum Associates, 1994
CHANG, S. Initial Psychometric Properties of a Brief Parent-Report Instrument for Assessing Tic Severity in Children with Chronic Tic Disorders. HIMLE, M. B.;TUCKER, B. T. P., et al. Child & Family Behavior Therapy: Taylor & Francis Group. 31: 181-191 p. 2009.
Hedman E, Ljotsson B, Lindefors N. Cognitive behavior therapy via the Internet: a systematic review of applications, clinical efficacy and cost-effectiveness. Expert Rev Pharmacoecon Outcomes Res. 2012 Dec;12(6):745-64. doi: 10.1586/erp.12.67.
PubMed 23252357Martino D, Pringsheim TM. Tourette syndrome and other chronic tic disorders: an update on clinical management. Expert Rev Neurother. 2018 Feb;18(2):125-137. doi: 10.1080/14737175.2018.1413938. Epub 2017 Dec 8.
PubMed 29219631
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Study Evaluating the Treatment Outcome of Combined Virtual Tic Training in Children and Adolescents With a Chronic Tic Disorder
- ClinicalTrials.gov ID
- NCT04678180
- Acronym / sponsor ID
- 1-10-72-231-20
- Conditions
- Chronic Tic Disorder
- Keywords
- Habit reversal training, Exposure response prevention, Children and adolescents, virtual training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 21 Dec 2020 (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.
Tics are unwanted, repetitive movements or sounds that are either simple or complex in appearance. Tic disorders often have a huge impact on children's life. The investigators have previously shown a positive outcome of tic training combining habit reversal training (HRT) and exposure response prevention (ERP) either as an individual therapy or in a group setting. However, young people and families are often busy, and having to use a full day as to attend to tic training often is difficult both for the young person and their families. Therefore, the present study focuses on the clinical outcome of combining virtual training with training at the hospital
Detailed description
Tics are unwanted, brief, repetitive, non-rhythmic movements or sounds that are classified as either simple or complex. Dependent on duration, tics are divided into transient tics and chronic tics. Tic disorders often have an early age of onset and may have a major impact on a young person's life. Treatment of a chronic tic disorder primarily comprises therapeutic intervention which consists of ERP (Exposure Response Prevention) and/or HRT (Habit Reversal Training).
The purpose of the project is to
- Evaluate the treatment outcome of combined video consultation/participating in training sessions at the hospital and of combined self-instructed video training/participating in training sessions at the hospital.
- Compare the treatment outcome of supplementary virtual consultation and supplementary video training via an app with a previous study on the treatment outcome of attending individual therapy (NISSEN, 2018) by means of benchmarking.
- In addition, expound on the significance of sensory modulation (sensitivity), not-just-right experience and the child's perception with regard to the severity of chronic tics and treatment outcome. Also, to investigate whether insight, sensitivity and the not-just-right experience change during treatment.
- As the app is newly developed in relation to the present study, the investigators wish to clarify the participants' evaluation of the app using a newly developed questionnaire (designed for this project). For comparison, a questionnaire has been designed for evaluating the applicability of the supplementary video sessions.
When patients are referred to the Tourette outpatient clinic, Aarhus University Hospital, Psychiatry, a comprehensive diagnostic assessment is carried out. The assessment is based on a modified version of the Schedule for affective disorders and schizophrenia for school-age children - present and lifetime version (K-SADS-PL). The K-SADS-PL information is used for confirming the primary diagnosis of chronic tics and for ensuring that none of the exclusion criteria have been met.
Inclusion criteria
The inclusion criteria are defined based on the ICD-10 diagnosis (International Classification of Diseases and Related Health Problems):
Chronic motor/vocal tics (DF95.1) Tourette syndrome (DF95.2), Age spectrum: 9-17 years old
Exclusion criteria
The exclusion criteria are defined as follows:
Patients with comorbidity such as mental retardation (IQ = 70 or less), psychosis, severe depression requiring treatment, suicidal behavior/threats or severe eating disorder.
Participated in tics training based on HRT/ERP treatment within the last six months.
Oral and written consent will be obtained from parents and children/adolescents (age 15 years and older).
The study will be an open, randomized controlled clinical study for children and adolescents with chronic tics disorders. The participants will be randomized using computer-generated randomization based on age and sex.
The participants will either be randomized for tics training with attendance combined with virtual training (group 1) or a combination of attendance and self-instructed training via videos on an app (group 2). Both settings are based on the "Niks til Tics" manual (NISSEN, 2018) that describes training in Habit Reversal Training (HRT) and Exposure Response Prevention (ERP) over nine sessions. Thus, two treatment groups will be set up:
Group 1 (treatment group 1) will consist of nine entire sessions (60 min each), but where four out of the nine sessions will be converted to video consultations. The content of the video consultations is comparable to the information and training the patients would have received if they attended at the clinic and which are defined in the "Niks til Tics" manual.
Group 2 (treatment group 2) will comprise five entire sessions (60 min) with clinic attendance, but where sessions 1 and 2 will be combined into one session with a duration of 120 min, session 4 will be held as usual with attendance after five weeks, session 8 will be held ten weeks after session 4, and session 9 will be held after two months. In addition, patients in group 2 will be given the opportunity to talk to the therapist on the phone. For the group 2 training sessions, an app has been developed for teaching patients the tics training method. A new app session will be released at each new treatment session, and the content of the app videos will follow the information and training, which the patients would have received if they had attended at the clinic and which are defined in the "Niks til Tics" manual.
All tic training sessions will be individual. The primary outcome goal includes the Yale Global Tics Severity Scale (YGTSS) in session 8. In order to follow the treatment, a parent report questionnaire and a self-report questionnaire will be used and evaluated in accordance with YGTSS (Golden standard). The questionnaires are based on Parent Tic Questionnaire (PTQ). Secondary outcome measures are Screen for Child Anxiety Related Emotional Disorders (SCARED), the Mood and Feelings Questionnaire (MFQ), Premonitory Urge Scale (PUTS), Beliefs About Tics Scale (BATS), NJR-C (not just right experiences), CATS (thoughts about experiences children may be exposed to), W-tc (worrying thoughts) and motivation questionnaire, and the parents are asked to fill in CBCL, BQ (general information) as well as a sensory profile (about hypersensitivity).
Statistical analyses The primary analysis will comprise a comparison of effect sizes within the treatment group, that is, an assessment of the reduction in tic intensity during the eight sessions. The difference in tic intensity between baseline and session 8 will be assessed at t-test. Effect sizes will be calculated by a ratio of the mean difference and the standard deviation of the difference between baseline and session 8 (SD diff). The confidence interval for effect sizes will be calculated using non-parametric bootstrap with 100 replications. At group sizes of 30 with an expected uniform YGTSS baseline of 25 (randomized) and with an expected SD of 6.2 (from a previous study (NISSEN 2018)), and a strength of 0.8 it should be possible to detect a decrease of point 3.4 (from baseline to session 8), which is statistically significant.
Responder level will be defined as a 25% reduction of the YGTSS total tics score.
The secondary analyses will study the reduction in tic intensity between the two treatment groups using unpaired t-test. At a group size of 30 and expected end YGTSS of 15 (SD 6.2) and strength of 0.80 (from a previous study (NISSEN 2018)), a difference of 4.6 between the two groups will be statistically significant.
Predictor analysis: baseline characteristics and baseline tic severity between the two groups will be compared using univariate Chi test for categorical variables and t-tests for continuous variables.
Tic severity will be assessed by independent raters.
Using benchmarking, the results of this treatment study will be compared with the results from a previous treatment study on HRT/ERP (NISSEN, 2018).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Group 1: a combination of treatment using virtual training (secure interactive video training) and training at the hospital. In total, nine sessions using a combined training of HRT and ERP Group 2: a combination of treatment using self-instructive videos and training at the hospital. In total, nine sessions using a combined training of HRT and ERP
| Arm | Type | Receives |
|---|---|---|
| Virtual tic training | Experimental | Behavioral: Combined HRT and ERPA combination of treatment using virtual tic training and training at the hospital. In total nine sessions using a combined training of HRT and ERP. In four of the nine sessions (session 3, 5, 6, 7) training is performed as a virtual training. All sessions last 60 minutes |
| Video tic training | Experimental | Behavioral: Combined HRT and ERPA combination of treatment using self-instructive videos and training at the hospital. In total nine sessions using a combined training of HRT and ERP. Four of the nine sessions are completed at the hospital (session 1 and 2 are combined 120 minutes, session 4: 60 minutes, session 8: 60 minutes and session 9: 60 minutes). For all sessions, self-instructive videos have been recorded instructing the child and their families how they should perform the training |
Who may qualify
- Ages
- 9 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- Comorbidity including
- Mental retardering
- Psychosis
- Severe depression
- Suicidal behavior
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 |
|---|---|---|
| Combined HRT and ERPtic training using the principles of HRT and ERP as to reduce tic intensity | Behavioural | Video tic training, Virtual tic training |
Primary outcome
Change of baseline Yale Global Tic Severity Scale (YGTSS) at 16 weeks, 24 weeks, 40 weeks, 68 weeks
Time frame: Baseline,16 weeks, 24 weeks, 40 weeks, 68 weeks
YGTSS - a clinician-administered semi-structured interview including a checklist of all tics present in the past week. It covers five dimensions divided into ten items including the number, frequency, intensity, complexity and interference of motor and vocal tics. Furthermore, it includes a separate evaluation of the functional impairment. Measures the change in total tic score and functional impairment. Interval 0-100, high score means a worse outcome
3 secondary outcomes
Change of baseline Premonitory Urge Scale (PUTS) 6 weeks, 16 weeks, 24 weeks, 40 weeks, 68 weeks
Time frame: Baseline, 6 weeks, 16 weeks, 24 weeks, 40 weeks, 68 weeks
Change of baseline Beliefs About Tics Scale (BATS) at 6 weeks, 16 weeks, 24 weeks, 40 weeks, 68 weeks
Time frame: Baseline, 6 weeks, 16 weeks, 24 weeks, 40 weeks, 68 weeks
Change of baseline Parent and child self-evaluating questionnaire at 16 weeks, 24 weeks, 40 weeks, 68 weeks
Time frame: Baseline,16 weeks, 24 weeks, 40 weeks, 68 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
- Results publication: PubMed 26520221Abramovitch A, Reese H, Woods DW, Peterson A, Deckersbach T, Piacentini J, Scahill L, Wilhelm S. Psychometric Properties of a Self-Report Instrument for the Assessment of Tic Severity in Adults With Tic Disorders. Behav Ther. 2015 Nov;46(6):786-96. doi: 10.1016/j.beth.2015.06.002. Epub 2015 Jun 18.
- Results publication: PubMed 30772854Andren P, Aspvall K, Fernandez de la Cruz L, Wiktor P, Romano S, Andersson E, Murphy T, Isomura K, Serlachius E, Mataix-Cols D. Therapist-guided and parent-guided internet-delivered behaviour therapy for paediatric Tourette's disorder: a pilot randomised controlled trial with long-term follow-up. BMJ Open. 2019 Feb 15;9(2):e024685. doi: 10.1136/bmjopen-2018-024685.
- Results publication: PubMed 10517055Birmaher B, Brent DA, Chiappetta L, Bridge J, Monga S, Baugher M. Psychometric properties of the Screen for Child Anxiety Related Emotional Disorders (SCARED): a replication study. J Am Acad Child Adolesc Psychiatry. 1999 Oct;38(10):1230-6. doi: 10.1097/00004583-199910000-00011.
- Results publication: PubMed 2768151Leckman JF, Riddle MA, Hardin MT, Ort SI, Swartz KL, Stevenson J, Cohen DJ. The Yale Global Tic Severity Scale: initial testing of a clinician-rated scale of tic severity. J Am Acad Child Adolesc Psychiatry. 1989 Jul;28(4):566-73. doi: 10.1097/00004583-198907000-00015.
- Results publication: PubMed 23850205Neal M, Cavanna AE. "Not just right experiences" in patients with Tourette syndrome: complex motor tics or compulsions? Psychiatry Res. 2013 Dec 15;210(2):559-63. doi: 10.1016/j.psychres.2013.06.033. Epub 2013 Jul 10.
- Results publication: PubMed 29956034Nissen JB, Kaergaard M, Laursen L, Parner E, Thomsen PH. Combined habit reversal training and exposure response prevention in a group setting compared to individual training: a randomized controlled clinical trial. Eur Child Adolesc Psychiatry. 2019 Jan;28(1):57-68. doi: 10.1007/s00787-018-1187-z. Epub 2018 Jun 28.
- Results publication: PubMed 26169350Ricketts EJ, Goetz AR, Capriotti MR, Bauer CC, Brei NG, Himle MB, Espil FM, Snorrason I, Ran D, Woods DW. A randomized waitlist-controlled pilot trial of voice over Internet protocol-delivered behavior therapy for youth with chronic tic disorders. J Telemed Telecare. 2016 Apr;22(3):153-62. doi: 10.1177/1357633X15593192. Epub 2015 Jul 13.
- Results publication: PubMed 31356288Singer HS. Tics and Tourette Syndrome. Continuum (Minneap Minn). 2019 Aug;25(4):936-958. doi: 10.1212/CON.0000000000000752.
- Results publication: PubMed 23332555Steinberg T, Harush A, Barnea M, Dar R, Piacentini J, Woods D, Shmuel-Baruch S, Apter A. Tic-related cognition, sensory phenomena, and anxiety in children and adolescents with Tourette syndrome. Compr Psychiatry. 2013 Jul;54(5):462-6. doi: 10.1016/j.comppsych.2012.12.012. Epub 2013 Jan 15.
- Results publication: PubMed 7759594Wood A, Kroll L, Moore A, Harrington R. Properties of the mood and feelings questionnaire in adolescent psychiatric outpatients: a research note. J Child Psychol Psychiatry. 1995 Feb;36(2):327-34. doi: 10.1111/j.1469-7610.1995.tb01828.x.
- Results publication: PubMed 16344654Woods DW, Piacentini J, Himle MB, Chang S. Premonitory Urge for Tics Scale (PUTS): initial psychometric results and examination of the premonitory urge phenomenon in youths with Tic disorders. J Dev Behav Pediatr. 2005 Dec;26(6):397-403. doi: 10.1097/00004703-200512000-00001.
- Results publicationACHENBACH TM. Child behavior checklist and related instruments. In The use of psychological testing for treatment planning and outcome assessment. Edited by Maurish ME. Hillsdale, NJ: Lawrence Erlbaum Associates, 1994
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Judith Nissen, phd principal investigator
Department of Child and Adolescent Psychiatry, Aarhus University Hospital, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined HRT and ERP in people with Chronic Tic Disorder, run by Aarhus University Hospital at 1 site in Denmark.
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 0 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 7 Feb 2025. 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 Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of baseline Yale Global Tic Severity Scale (YGTSS) at 16 weeks, 24 weeks, 40 weeks, 68 weeks (time frame: Baseline,16 weeks, 24 weeks, 40 weeks, 68 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04678180, which also lists 16 linked publications.
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 7 Feb 2025.