Internet-delivered Cognitive Behavior Therapy (CBT) for Children Age 8-12 Years With Anxiety Disorders
This study is ongoing, but not recruiting participants.
Sponsor:
Karolinska Institutet
Collaborators:
Stockholm County Council, Sweden
Barn-och ungdomspsykiatrin (BUP), Stockholm
Information provided by (Responsible Party):
Eva Serlachius, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01533402
First received: February 6, 2012
Last updated: March 11, 2013
Last verified: March 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to investigate whether a 10 week Internet-delivered CBT is a feasible approach to treat children (age 8-12 years) with anxiety disorder (social phobia, panic disorder, specific phobia, generalized anxiety disorder or separation anxiety disorder). The program is directed toward both the parents and children. The patients work with the treatment is supported through on-line contact with a therapist. Approximately 128 patients will be included in the study and randomized to either condition. All included patients are assessed before the treatment starts and after 10 weeks (post treatment). Follow-up assessments are conducted at 3 and 12 months after treatment.
| Condition | Intervention |
|---|---|
|
Anxiety Disorders |
Behavioral: therapist support Behavioral: Internet-delivered CBT |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Internet-delivered Cognitive Behavior Therapy (CBT) Treatment for Anxiety Disorders in Children Age 8-12 Years - a Randomised Controlled Trial |
Resource links provided by NLM:
Further study details as provided by Karolinska Institutet:
Primary Outcome Measures:
- Anxiety symptoms [ Time Frame: two - three weeks pre treatment and 10 weeks, 3 months and 12 months post treatment ] [ Designated as safety issue: No ]Change from baseline in anxiety symptoms. Clinician Severity Rating (CSR) assessed by a clinician with Anxiety Diagnostic Interview Schedule (ADIS C/P).
Secondary Outcome Measures:
- Anxiety symptoms [ Time Frame: two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment ] [ Designated as safety issue: No ]Change from baseline in anxiety symptoms. Fear Survey Schedule for Children (FSSC-C/P).
- Quality of Life [ Time Frame: two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment ] [ Designated as safety issue: No ]Quality of Life (QOLI)
- comorbidity [ Time Frame: two - four weeks before treatment starts ] [ Designated as safety issue: No ]Development and Wellbeing Assessment (DAWBA)
- Depressive symptoms [ Time Frame: two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment ] [ Designated as safety issue: No ]Children Depression Scale (CDI)
- Funtional impairment [ Time Frame: two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment ] [ Designated as safety issue: No ]Children´s Global Assessment Scale (CGAS)
- Client Satisfaction Scale [ Time Frame: two weeks before treatment and 10 weeks, 3 and 12 months post treatment ] [ Designated as safety issue: No ]Client Satisfaction Scale (CSS)
- Parental psychopathology [ Time Frame: two weeks pre treatment ] [ Designated as safety issue: No ]Primary Care Evaluation of Mental disorders (Prime-MD)
- Anxiety symptoms [ Time Frame: two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment ] [ Designated as safety issue: No ]Change from baseline in anxiety symptoms. Penn State Worry Questionnaire for Children (PSWQ-C).
- Anxiety symptoms [ Time Frame: two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment ] [ Designated as safety issue: No ]Change from baseline in anxiety symptoms. Separation Anxiety Inventory for Children (SAI-C/P)
- Anxiety symptoms [ Time Frame: two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment ] [ Designated as safety issue: No ]Change from baseline in anxiety symptoms. Social Phobia and Anxiety Inventory (SPAI-C/P)
- Anxiety symptoms [ Time Frame: two weeks pre treatment and 10 weeks, 3 months and 12 months post treatment ] [ Designated as safety issue: No ]Change from baseline in anxiety symptoms. Spence Child Anxiety Scale C/P (SCAS-C/P).
| Estimated Enrollment: | 128 |
| Study Start Date: | February 2012 |
| Estimated Study Completion Date: | November 2013 |
| Estimated Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Attention control
Weekly support from therapist without CBT-interventions
|
Behavioral: therapist support
Weekly therapist support without CBT-interventions
|
|
Experimental: Internet CBT
Internet-delivered cognitive behavioural therapy with therapy support
|
Behavioral: Internet-delivered CBT
Internet-delivered cognitive behavioural therapy with therapist support
|
Eligibility| Ages Eligible for Study: | 8 Years to 12 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- primary diagnosis of social phobia, panic disorder, specific phobia, generalized anxiety disorder or separation anxiety disorder,
- age between 8 and 12 years,
- ability to read and write Swedish and
- with access to a computer and use of internet.
Exclusion Criteria:
- Presence of neuropsychiatric diagnosis or a primary psychiatric disorder other than those that the treatment aims at.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Eva Serlachius, Principal Investigator, MD, PhD, Karolinska Institutet |
| ClinicalTrials.gov Identifier: | NCT01533402 History of Changes |
| Other Study ID Numbers: | 2011/2027-31/5 |
| Study First Received: | February 6, 2012 |
| Last Updated: | March 11, 2013 |
| Health Authority: | Sweden: Regional Ethical Review Board |
Keywords provided by Karolinska Institutet:
|
Cognitive behavior therapy Internet Anxiety disorders Children |
Additional relevant MeSH terms:
|
Anxiety Disorders Mental Disorders |
ClinicalTrials.gov processed this record on June 18, 2013