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 (NCT)	NCT00164203
Protocol serial number	MCT-68787
Sponsor	The Centre for Addiction and Mental Health (Toronto) (Canada)
Funder	Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: 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

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

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Evaluating a school-based intervention for children at risk for depression and anxiety disorders: a randomised controlled trial
Study objectives	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(s)	Centre for Addiction and Mental Health Ethics Board approved on the 5th August 2004
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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).
Key secondary outcome measure(s)	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
Completion date	30/09/2008

Eligibility

Participant type(s)	Patient
Age group	Child
Sex	All
Target sample size at registration	140
Key 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.
Key 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
Date of first enrolment	01/10/2004
Date of final enrolment	30/09/2008

Locations

Countries of recruitment

Canada

Study participating centre

Hospital for Sick Children

Toronto
M5G 1X8
Canada

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not 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