Condition category
Mental and Behavioural Disorders
Date applied
09/09/2005
Date assigned
09/09/2005
Last edited
06/07/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

01/10/2004

Overall trial end date

30/09/2008

Reason abandoned

Eligibility

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

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

http://www.camh.net/

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

Results - basic reporting

Publication summary

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20602433

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