Objective: To test the hypotheses that Feedback Informed Treatment together with treatment as usual will show significant more improvement than treatment as usual alone.
ID
Source
Brief title
Condition
- Psychiatric and behavioural symptoms NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters/endpoints: The primary outcome measure will be quality of
life measured with the KIDSCREEN-27.
Secondary outcome
Secondary outcome measure will be parental distress measured with the OBVL.
Background summary
The efficacy of evidence-based treatment drastically decreases in everyday
clinical practice (Weisz, Ugueto, Cheron &Herren, 2013). The use of immediate
feedback is one important recommendation in improving the outcome of treatment
(Weisz et al. 2013). Feedback Informed Treatment (FIT) is a promising feedback
approach developed by Scott Miller and Barry Duncan (2004). Research showed
promising results when this method is used with adult patients in general
mental health care (Miller, Duncan, Brown, Sorrel &Chalk, 2006, Anker, Duncan
&Sparks 2009).
The basic assumption of FIT is to be better understand changes in the patient
by systematically monitor the results of the therapeutic allience and changes
in the patient wellbeing. By using the results in each session and provide
direct feedback, it can be assessed whether the treatment is appropriate and
useful. Insufficient progress may lead to other actions. This study will
evaluate the efficacy of FIT in children and adolescents diagnosed with
(comorbid ) and autism spectrum disorders (comorbid ) ADHD and their parents on
their quality of life.
Study objective
Objective: To test the hypotheses that Feedback Informed Treatment together
with treatment as usual will show significant more improvement than treatment
as usual alone.
Study design
Study design: Cluster Randomized controlled intervention study. Departments
will be randomized assigned to the experimental group (FIT department) or the
*treatment as usual* (control) group. The unit of randomization will be the
departments. Individual patients will be the unit of analysis.
Intervention
Intervention: Two groups of patients will be compared; an intervention group
and a control group. Both treatment groups will receive care as usual. Care as
usual is a multi-disciplined treatment program that consists of the following
treatments; medication, cognitive behavioral therapy, behavioral therapy,
psycho-education group for parents and children, EMDR, psycho-motorial therapy
and creative therapy. Treatment for ADHD and ASS is protocolled, but may vary
depending on the severity of the illness, preferences of parents and/or
therapists. The experimental group will add the FIT method to the care as
usual. FIT consists of two brief, patient rated, four-item visual analogue
scales called the Outcome Rating Scale (ORS) and Session Rating Scale (SRS).
The ORS measures the patients perception of well-being and the SRS the patients
perception of the therapeutic alliance. A web-based program called
"FIT-Outcomes" will be used to support the use of the ORS and the SRS. With
FIT-Outcomes it's possible to administer the scales online with the use of an
IPad and get instant feedback. Each session, the graphical results are
discussed with the patient.
Study burden and risks
Nature and extent of the burden and risks associated with participation,
benefit and group relatedness: The burden and the risks for children and
parents are minimal, since both groups receive treatment as usual. The ORS and
SRS are two brief lists and will just take one minute to score in the session.
The departments who are invited to participate in the study will be given
information about the objectives of the study and the practical impact it may
have on their practice. They will be told that they will be randomized to an
experimental or control group. A written consent from all practices will be
asked.
Reinier Postlaan 12
Nijmegen 6525 GC
NL
Reinier Postlaan 12
Nijmegen 6525 GC
NL
Listed location countries
Age
Inclusion criteria
Children, adolescents and young adults aged from 6-18 year (IQ *85) referred to the specialized outpatient ASS and ADHD teams
Exclusion criteria
IQ <85
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 | NL48681.091.14 |