Contact information
Type
Scientific
Primary contact
Dr Katharina Manassis
ORCID ID
Contact details
Hospital for Sick Children
Department of Psychiatry
555 University Avenue
Toronto
M5G 1X8
Canada
+1 416 813 7464
katharina.manassis@sickkids.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00164203
Protocol/serial number
MCT-68787
Study information
Scientific title
Evaluating a school-based intervention for children at risk for depression and anxiety disorders: a randomised controlled trial
Acronym
Study hypothesis
Hypothesis 1a: Children in the intervention condition will show greater symptom reduction relative to children in the control condition (primary outcome: anxiety symptoms)
Hypothesis 1b: Children in the intervention condition will show fewer symptoms during follow-up relative to children in the control condition
Hypothesis 2: Children with anxious or depressive symptoms treated in the school setting using CBT have a lower risk of developing internalising disorders within 1 year of treatment than children in a control condition
Hypothesis 3: Self-esteem, anxiety and depression-related impairment, and academic functioning will improve more in intervention participants than in controls
Hypothesis 4: School characteristics, child age, and attitudes of participating personnel are predictive of treatment response
Ethics approval
Centre for Addiction and Mental Health Ethics Board approved on the 5th August 2004
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Condition
Depression and anxiety in children
Intervention
In partnership with the school system, we will evaluate and disseminate a preventive, cognitive behavioural intervention (CBT) for children at risk for anxiety or depression. Participants will be randomly assigned to either CBT or an after school program of equal duration (control condition). When there are a sufficient number of suitable participants within a school, both CBT and control conditions will be provided in the same school. These children will participate once a week in the 12-session 'Feelings Club' program (Wilansky & Manassis, 2003), administered for one hour immediately after school. There will be 6 to 10 participants in each 'Feelings Club' group. The control group will also be labeled 'Feelings Club', but the content will differ. Instead of learning CBT techniques, these children will participate in a series of enjoyable after-school activities and games once a week for one hour x 12 weeks. There will also be 6 to 10 participants in each of these groups.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Reduction of anxious symptoms. Childrens score on the standardised self-report inventory: MASC. Measured immediately post-intervention and again one year after that (i.e. 15 months after start).
Secondary outcome measures
All are measured immediately post-intervention and again one year after that (i.e. 15 months after start)
1. Reduction of depressive symptoms - will be assessed using CDI
2. The emergence of disorder - will be ascertained using ADIS
3. Self-esteem - will be assessed using Harter Childrens Self-Concept Scales
4. Impairment - will be assessed using the Children Global Assessment Scale
5. Academic functioning - will be assessed using information from the childrens report cards, obtained with parental permission
Overall trial start date
01/10/2004
Overall trial end date
30/09/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Screening 'gold standard' self-report inventories include: Multidimensional Anxiety Scale for Children (MASC; March, 1998) and Childrens Depression Inventory (CDI; Kovacs, 1983). Children 5 - 11 years old, either sex, with t-score elevations >60 on either the total score or at least 4 subscales of either instrument will be considered eligible for study.
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
140
Participant exclusion criteria
1. Already meet criteria for disorder on the ADIS
2. Are unable to complete the inventories due to intellectual impairment or weak English skills (limiting the benefits of cognitive behavioral therapy)
3. Are already engaged in ongoing psychiatric or psychological treatment that could confound study intervention effects
4. Elevated 'externalising' scores on the CBCL (t-score greater than 60), as these children may be difficult to manage in CBT groups, and may obtain more benefit from other interventions
Recruitment start date
01/10/2004
Recruitment end date
30/09/2008
Locations
Countries of recruitment
Canada
Trial participating centre
Hospital for Sick Children
Toronto
M5G 1X8
Canada
Sponsor information
Organisation
The Centre for Addiction and Mental Health (Toronto) (Canada)
Sponsor details
1001 Queen Street West
#1127
Toronto
M6J 1H4
Canada
nas_farzan@camh.net
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-68787)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20602433
Publication citations
-
Results
Manassis K, Wilansky-Traynor P, Farzan N, Kleiman V, Parker K, Sanford M, The feelings club: randomized controlled evaluation of school-based CBT for anxious or depressive symptoms., Depress Anxiety, 2010, 27, 10, 945-952, doi: 10.1002/da.20724.