Treatment Outcome of Combined Virtual Tic Training in Children and Adolescents With a Chronic Tic Disorder

NCT04678180 | Active Not Recruiting

• 1 other identifier: 1-10-72-231-20
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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 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

Conditions

Chronic Tic Disorder

Keywords

Habit reversal training; Exposure response prevention; Children and adolescents; virtual training

Outcome Measures

Primary Outcomes (1)

• 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

  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

  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

  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

  Baseline,16 weeks, 24 weeks, 40 weeks, 68 weeks

Other Outcomes (6)

• Change of baseline Screen for Child Anxiety Related Emotional Disorders (SCARED) at 6 weeks, 16 weeks, 24 weeks, 40 weeks, 68 weeks

  Baseline, 6 weeks, 16 weeks, 24 weeks, 40 weeks, 68 weeks

• Change of baseline Mood and Feelings Questionnaire (MFQ) at 6 weeks, 16 weeks, 24 weeks, 40 weeks, 68 weeks

  Baseline, 6 weeks, 16 weeks, 24 weeks, 40 weeks, 68 weeks

• Change of NJR-C (not just right) at 6 weeks, 16 weeks, 24 weeks, 40 weeks, 68 weeks

  Baseline, 6 weeks, 16 weeks, 24 weeks, 40 weeks, 68 weeks

Study Arms (2)

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

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

Behavioral: Combined HRT and ERP

Interventions

Combined HRT and ERP BEHAVIORAL

tic training using the principles of HRT and ERP as to reduce tic intensity

Video tic training; Virtual tic training

Eligibility Criteria

• Age: 9 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Chronic motor/vocal tics (DF95.1)
• Tourettes syndrom (DF95.2)

You may not qualify if:

• 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

Sponsors & Collaborators

• Aarhus University Hospital: lead

Study Sites (1)

Department of child and adolescent Psychiatry, Aarhus University Hospital

Aarhus, 8240, Denmark

Location

Related Publications (16)

• 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.

  PMID: 26520221 RESULT

• Andren 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.

  PMID: 30772854 RESULT

• Birmaher 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.

  PMID: 10517055 RESULT

• Leckman 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.

  PMID: 2768151 RESULT

• Neal 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.

  PMID: 23850205 RESULT

• Nissen 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.

  PMID: 29956034 RESULT

• Ricketts 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.

  PMID: 26169350 RESULT

• Singer HS. Tics and Tourette Syndrome. Continuum (Minneap Minn). 2019 Aug;25(4):936-958. doi: 10.1212/CON.0000000000000752.

  PMID: 31356288 RESULT

• Steinberg 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.

  PMID: 23332555 RESULT

• Wood 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.

  PMID: 7759594 RESULT

• Woods 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.

  PMID: 16344654 RESULT

• ACHENBACH 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

  RESULT

• 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.

  RESULT

• 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.

  PMID: 23252357 RESULT

• Martino 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.

  PMID: 29219631 RESULT

• TEODORO M. Children's Automatic Thoughts Scale (Cats): adaptation and psychometric properties. Psico-USF [online], vol.18, n.1, pp.89-98. ISSN 1413-8271. https://doi.org/10.1590/S1413-8271201300100010, 2013

  RESULT

MeSH Terms

Conditions

Tic Disorders

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Judith Nissen, phd

  Department of Child and Adolescent Psychiatry, Aarhus University Hospital, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The assessor of outcome was blinded to any previous evaluations
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, senior researcher

Model Details: 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

Study Record Dates

• First Submitted: December 9, 2020
• First Posted: December 21, 2020
• Study Start: January 1, 2021
• Primary Completion: April 30, 2022
• Study Completion: December 30, 2025
• Last Updated: February 7, 2025

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)