Condition category
Mental and Behavioural Disorders
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr Katharina Manassis


Contact details

Hospital for Sick Children
Department of Psychiatry
555 University Avenue
M5G 1X8
+1 416 813 7464

Additional identifiers

EudraCT number number


Protocol/serial number


Study information

Scientific title

Evaluating a school-based intervention for children at risk for depression and anxiety disorders: a randomised controlled trial


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


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet


Depression and anxiety in children


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



Not Applicable

Drug names

Primary outcome measure

Reduction of anxious symptoms. Children’s 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 Children’s Self-Concept Scales
4. Impairment - will be assessed using the Children Global Assessment Scale
5. Academic functioning - will be assessed using information from the children’s report cards, obtained with parental permission

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

Screening 'gold standard' self-report inventories include: Multidimensional Anxiety Scale for Children (MASC; March, 1998) and Children’s 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


Age group




Target number of participants


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


Recruitment end date



Countries of recruitment


Trial participating centre

Hospital for Sick Children
M5G 1X8

Sponsor information


The Centre for Addiction and Mental Health (Toronto) (Canada)

Sponsor details

1001 Queen Street West
M6J 1H4

Sponsor type

Research organisation



Funder type

Research organisation

Funder name

Canadian Institutes of Health Research (CIHR) (Canada) - (ref: MCT-68787)

Alternative name(s)

Funding Body Type

Funding Body Subtype


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

Publication citations

  1. 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.

Additional files

Editorial Notes