The aim is to study the feasibility of a brief, intensive, outpatient group treatment (ERP) for youths with chronic tic disorders/Tourette Syndrome (TS), to improve treatment outcome, daily functioning/quality of life and treatment satisfaction.…
ID
Source
Brief title
Condition
- Psychiatric disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Assessments will be done pre- (T0), and post treatment (T1), and in a follow-up
assessment (T2) which is planned 2 months after T0.
Key-outcome: tic severity (Yale Global Tic Severity Scale; YGTSS) and
premonitory urges (Premonitory Urges for Tics Scale; PUTS).
Secondary outcome
Demographic variables/patient characteristics: semi-structured interview,
medical files, psychiatric comorbidities (Anxiety Disorder Interview Schedule;
ADIS).
Secondary outcomes:
- emotional/behavioural functioning, including concentration/attention problems
(Child Behavior Checklist; CBCL).
- quality of life (Gilles de la Tourette Syndrome Quality of Life Scale for
children and adolescents; C&A-GTS-QOL).
Feasibility will be assessed by: (1) attendance/drop-out rates, (2) treatment
satisfaction forms (parent and child version), specifically designed for this
study, (3) semi-structured interviews with stakeholders (children, parents,
caregivers and administrators). These assessments give insight into the factors
that will enhance or hinder implementation of Tackle your Tics. Key feasibility
questions are: What are needs and concerns of participating parents and
children? What are the requirements for mental health organisations to apply to
this programme?
Background summary
Tic disorder, like Tourette Syndrome (TS), can have a serious and long-lasting
negative impact on daily functioning and quality of life of children and
families. Behavioural treatment for tics is recommended as first-line
intervention according to European guidelines.
Although research into behavioural treatments for tics reports moderate to high
effect sizes (0-57-1.5), tic reductions remain relatively low (on average 30%
on the YGTSS questionnaire). Thus, there is much room for improvement. In
addition, utilization rates for evidence-based behavioural therapies remain low.
The lack of locally available trained therapists is a common treatment barrier.
Families have to travel far and home exercises demand a lot of motivation and
discipline. As a consequence of low access, many children get medical treatment
although they prefer behavioural treatments.
Recently, case studies in the USA and UK have suggested that brief, intensive
forms of behavioural therapy for TS are as effective as weekly therapy
sessions. Besides, promising treatment outcomes have been found for an
intensive outpatient grouptherapy (ERP) for children with OCD (*OCD-week* at
expertise centre the Bascule). Also in other patient populations (e.g.
adolescents with post-traumatic stress disorder, PTSD, intensive forms of
behavioural treatment have been successful. Moreover, research in anxiety
disorders showed that treatment success may even be larger using intensive
brief treatment compared to traditional approaches. However, we currently lack
knowledge on the feasibility of an intensive form of ERP for tic disorders.
Study objective
The aim is to study the feasibility of a brief, intensive, outpatient group
treatment (ERP) for youths with chronic tic disorders/Tourette Syndrome (TS),
to improve treatment outcome, daily functioning/quality of life and treatment
satisfaction. This pilot is necessary to obtain the first data to compete for
major funding for a larger mulitcenter clinical trial, testing the
effectiveness of this brief intensive ERP group treatment. If found effective,
we aim to implement this programme (inter)nationally to make it available to
all patients with tic disorders. In addition, this project offers training
opportunities for new therapists.
Study design
Design: feasibility pilot study, consisting of four-day intensive group-based
exposure and response prevention (ERP).
Recruitment: participants will be recruited by the Dutch Tourette Association.
Sample size/power calculation: This pilot study will consist of 2 patient
groups of maximally 7 children per group (total sample: N= 14). Since this is a
pilot, no formal power calculation is necessary.
Assessments will be done pre- (T0), post-treatment (T1), and in a follow-up
assessment (T2) which is planned 2 months after T0.
Intervention
Tackle your Tics is a four-day treatment programme, based on the evidence-based
ERP-protocol for tics developed by Verdellen et al. (2011) and positive
outcomes of the Bascule *OCD-week*. Therapy sessions are executed individually
as well as in small groups of 2 - 3 children, in which children assist each
other (by timing, registering tics and encouraging). By adding
psycho-education, group support and relaxing activities, motivation and fun
will be enhanced and drop out reduced. We will utilise BT-Coach, a mobile
application that helps patients to practice ERP exercises in the absence of a
therapist. Additionally, there will be two parent meetings. One week after the
first 3 therapy days, there will be a follow up treatment day.
Study burden and risks
No burden or risks are expected from participation. Children and their families
will have better access to brief behavioural treatment, that can be followed
during holidays or short breaks from school. In this pilot study, we offer
(optional) family accommodation and traveling costs for families living
throughout the Netherlands and have to travel long distances. This will
overcome possible barriers for families wanting to receive behavioural
treatment for tics.
Meibergdreef 5
Amsterdam 1105 AZ
NL
Meibergdreef 5
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Inclusion criteria: (a) youths aged 9 to 17 years, (b) diagnosed with Tourette Syndrome or persistent (motor/vocal) tic disorder, using DSM-5 criteria, (c) with moderate or greater severity as measured by the YGTSS total score >13 (>9 for children with motor or vocal tics only).
Exclusion criteria
Exclusion criteria (examined during intake interviews): (a) Behavioural treatment for tics in the past 12 months, (b) pharmacological treatment (for tics or diagnosed psychiatric disorders) that is not been stable the past six weeks or with planned changes during study participation, (c) poor mastery of the Dutch language, (d) IQ < 75, (e) serious physical disease, (f) substance abuse, (g) suicidality, (h) psychotic disorders, (i) poor group functioning. Since tic disorders are seldom seen without comorbidities, co-occurring attention deficit*hyperactivity disorder, obsessive*compulsive disorder, other anxiety disorders or depressive disorders are allowed, unless the disorder requires immediate treatment or change in current treatment.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL66340.018.18 |