The aim is to study the effectivity 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. If…
ID
Source
Brief title
Condition
- Psychiatric and behavioural symptoms NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Assessments will be done pre- (T1), post-treatment (T2), and in follow-up
assessments (T3 after 3-4 months and T4 after 6-7 months).
Key-outcome: tic severity (Yale Global Tic Severity Scale; YGTSS)
Secondary outcome
Demographic variables/patient characteristics: semi-structured interview ,
medical files, psychiatric comorbidities (Anxiety Disorder Interview Schedule;
ADIS).
Secondary outcomes:
- quality of life (Gilles de la Tourette Syndrome Quality of Life Scale for
children and adolescents; C&A-GTS-QOL).
- emotional / behavioral functioning (Child Behavior Checklist; CBCL).
- premonitory urges (Premonitory Urges for Tics scale; PUTS)
- family functioning: parental stress
- treatment alliance/preference
- cost effectivity
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. Our previous pilot study showed the
brief, intensive treatment program Tackle your Tics was feasible, parents and
children were satisfied about this form of treatment, and we found indications
of improvement of tic severity as well as quality of life.
Study objective
The aim is to study the effectivity 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. 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 opportunities for personalizing treatment and
training opportunities for new therapists.
Study design
Design: randomized controlled trial (RCT), consisting of 4-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 7 patient
groups of 8 children per group and a waiting list condition group (total
sample: N= 104).
Intervention
Tackle your Tics is a 4-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 in small
groups of 2 children, in which children assist each other (by timing,
registering tics and encouraging). By adding psychoeducation, 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
booster day. After 1 months there is a follow up afternoon.
Study burden and risks
No burden or risks are expected from participation. Children and their families
will have better access to brief behavioural treat ment, that can be followed
during holidays or short breaks from school.
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
In other registers
Register | ID |
---|---|
CCMO | NL71514.018.19 |