The main objective of the study is to evaluate the efficacy of the *Blended Coping Cat* program in reducing anxiety levels in children diagnosed with anxiety disorders and possible ADHD, ASD, mild intellectual disability or borderline intellectual…
ID
Source
Brief title
Condition
- Anxiety disorders and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the measured difference in reported anxiety level
and anxiety diagnosis (ADIS-C, RCADS).
Secondary outcome
The health care consumption of the child and the parents (TIC-P), excluding the
research intervention is the second study parameter. The EQ-5d will be used to
look at health outcome as judged by the individual respondents and finally a
qualitative interview is conducted to look at the experiences of clients
(parents en children) and therapists with the blended intervention.
Background summary
Anxiety is a normal and useful part of development, but becomes a problem when
fears are extreme or prolonged. Anxiety disorders are common amongst children
and adolescents and can lead to problems in development. Many children with
psychiatric disorders like ADHD or ASD or mild intellectual
disability/borderline intellectual functioning experience high anxiety levels.
Cognitive behaviour therapy has been shown to be an effective treatment in a
face to face setting, but there are no evidence based internet interventions
for children with anxiety disorders and possible comorbid psychiatric or
intellectual disabilities. The aim of this study is to investigate the
effectiveness of the blended version of the Coping Cat Program in comparison
with a wait list control group in children and adolescents who are diagnosed
with ADHD, ASD, or mild intellectual disability/borderline intellectual
functioning and a comorbid anxiety disorder.
Study objective
The main objective of the study is to evaluate the efficacy of the *Blended
Coping Cat* program in reducing anxiety levels in children diagnosed with
anxiety disorders and possible ADHD, ASD, mild intellectual disability or
borderline intellectual functioning (50The second objective is to evaluate the cost-effectiveness of the *Blended
Coping Cat* program in children diagnosed with anxiety disorders and possible
ADHD, ASD, mild intellectual disability or borderline intellectual functioning
and to evaluate the experience of patients and therapists using the *Blended
Coping Cat* program.
Study design
This is a stratified randomized wait-list controlled trial.
Intervention
Children in the intervention condition will be treated with the blended Coping
Cat Program and are compared to a wait-list control group.
Study burden and risks
Risks are considered minimal. Two additional questionnaire and if applicable an
intelligence test will be completed by the child/adolescent and one additional
questionnaire by the parent/legal representative before the
intervention/waiting list condition; and two questionnaires will be completed
by the child and three addiotional ones by the parent/legal representative
after the intervention/waiting list condition. These are the only burden for
the participants.
Reinier Postlaan 12
Nijmegen 6525 GC
NL
Reinier Postlaan 12
Nijmegen 6525 GC
NL
Listed location countries
Age
Inclusion criteria
1. Children (boys and girls) aged between 8;0 years and 17;11 years
2. Diagnosed with an anxiety disorder, classified by the DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, 2000) by a child- and adolescent psychiatrist within Karakter.
3. Optionally diagnosed with one of the below comorbid disorders
a) ADHD
b) ASD
c) Mild intellectual disability or borderline intellectual functioning (504. Access to a PC with internet connection
Exclusion criteria
1. Children receiving other treatment focused on the anxiety disorder
2. Acute psychoses
3. Children with current suicidal problems
4. Children with severe motor or visual impairment
5. Participation in another clinical trial simultaneously
6. Insufficient motivation to follow the 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 | NL52685.091.15 |
| OMON | NL-OMON26513 |