The feelings club: Evaluating a school-based intervention for children at risk for depression and anxiety disorders

ISRCTN ISRCTN88858028
DOI https://doi.org/10.1186/ISRCTN88858028
ClinicalTrials.gov number NCT00164203
Secondary identifying numbers MCT-68787
Submission date
09/09/2005
Registration date
09/09/2005
Last edited
06/07/2010
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Katharina Manassis
Scientific

Hospital for Sick Children
Department of Psychiatry
555 University Avenue
Toronto
M5G 1X8
Canada

+1 416 813 7464
katharina.manassis@sickkids.ca

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Scientific titleEvaluating a school-based intervention for children at risk for depression and anxiety disorders: a randomised controlled trial
Study objectivesHypothesis 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(s)Centre for Addiction and Mental Health Ethics Board approved on the 5th August 2004
Health condition(s) or problem(s) studiedDepression and anxiety in children
InterventionIn 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 typeOther
Primary outcome measureReduction 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 measuresAll 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 study start date01/10/2004
Completion date30/09/2008

Eligibility

Participant type(s)Patient
Age groupChild
SexBoth
Target number of participants140
Key inclusion criteriaScreening '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.
Key exclusion criteria1. 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
Date of first enrolment01/10/2004
Date of final enrolment30/09/2008

Locations

Countries of recruitment

  • Canada

Study participating centre

Hospital for Sick Children
Toronto
M5G 1X8
Canada

Sponsor information

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

1001 Queen Street West, #1127
Toronto
M6J 1H4
Canada

nas_farzan@camh.net
http://www.camh.net/
ROR logo https://ror.org/03e71c577

Funders

Funder type

Research organisation

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-68787)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/10/2010 Yes No
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