Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000940279
Ethics application status
Approved
Date submitted
16/10/2009
Date registered
3/11/2009
Date last updated
15/12/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Promoting emotional health among children
Scientific title
An early intervention for mental health problems among children: Comparisons, Openess, Peers and Esteem
Secondary ID [1] 288167 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression in children 252020 0
Anxiety in children 252021 0
Condition category
Condition code
Mental Health 252213 252213 0 0
Depression
Mental Health 252214 252214 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The quasi-experimental intervention is designed to build resilience and equip children with the skills and strategies to use social comparisons in a positive and balanced way. The intervention will involve training children to appreciate individual differences and identify strengths in themselves and others. Children will also receive training in cognitive and behavioural strategies to lessen the impact of any negative comparisons, challenge negative beliefs about the self, and ensure they do not rely solely on the use of social comparisons to develop their self-esteem. The intervention will be adminstered to children in groups of 20 to 25 by a trained facilitator. There will be one hour weekly session for a total of 8 weeks.
Intervention code [1] 241422 0
Prevention
Intervention code [2] 241437 0
Treatment: Other
Comparator / control treatment
The control group will not receive the intervention. They will participate in their classes as usual. However, they will be assessed on all the outcome measures as per the intervention group.
Control group
Active

Outcomes
Primary outcome [1] 253082 0
Depressive symptoms will be assessed using a validated self-report measure: the Children's Depression Inventory
Timepoint [1] 253082 0
Pre, and immediately post, 1 month, 6 months and 12 months post intervention
Secondary outcome [1] 257936 0
Anxiety symptoms will be assessed using a validated self-report measure: Revised Children's Manifest Anxiety Scale
Timepoint [1] 257936 0
Pre, and immediately post, 1 month, 6 months and 12 months post intervention
Secondary outcome [2] 257937 0
Self-concepts will be assessed using a validated self-report measure: Self-Description Questionnaire
Timepoint [2] 257937 0
Pre, and immediately post, 1 month, 6 months and 12 months post intervention

Eligibility
Key inclusion criteria
All children from participating schools in grade 3 and 4 who have parental consent
Minimum age
8 Years
Maximum age
11 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Only children who do not have parental consent

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Schools have been randomly allocated in pairs by tossing a coin to the intervention or control groups. Allocation to the two groups was not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/04/2009
Actual
30/04/2009
Date of last participant enrolment
Anticipated
Actual
30/08/2009
Date of last data collection
Anticipated
Actual
Sample size
Target
600
Accrual to date
Final
636
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 243891 0
Charities/Societies/Foundations
Name [1] 243891 0
Australian Rotary Health Research Fund
Country [1] 243891 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Australian Rotary Health Research Fund
Address
PO Box NSW 2150
Paramatta NSW 2124
Country
Australia
Secondary sponsor category [1] 251236 0
None
Name [1] 251236 0
Address [1] 251236 0
Country [1] 251236 0
Other collaborator category [1] 911 0
Individual
Name [1] 911 0
Marita McCabe
Address [1] 911 0
School of Psychology
Deakin University
Burwood Highway
Burwood VIC 3125
Country [1] 911 0
Australia
Other collaborator category [2] 912 0
Individual
Name [2] 912 0
Helen Skouteris
Address [2] 912 0
School of Psychology
Deakin University
Burwood Highway
Burwood VIC 3125
Country [2] 912 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 244008 0
Deakin University
Ethics committee address [1] 244008 0
School of Psychology
Deakin University
Burwood Highway
Burwood VIC
3125
Ethics committee country [1] 244008 0
Australia
Date submitted for ethics approval [1] 244008 0
Approval date [1] 244008 0
15/12/2008
Ethics approval number [1] 244008 0
CE207-2008

Summary
Brief summary
The aim of the current study is to implement the early intervention program, COPE (Comparisons, Openness, Peers and Esteem), designed to build resilience and improve factors related to mental health problems among primary school children. It focuses on children aged between 8 and 10 years, as this is a crucial time to implement early intervention strategies to enhance children’s abilities to cope with psychosocial stressors and foster the development of positive mental health and well-being. This is also the age when children begin to frequently use social comparisons and are most vulnerable to the negative impact of these comparisons.

Social comparisons are frequently used by children to learn about their own abilities and individual differences. As these social comparisons are an integral component of children’s social and emotional development, they can not be eliminated. However, for many children, an over reliance on social comparisons can lead to maladaptive coping skills, negative thought processes, pessimistic attributions, low self-esteem, and other negative beliefs about the self; all of which are known to be factors that heighten the risk of developing mental health problems.

We have developed and trialled our program, COPE, which will build children’s resilience and equip children with strategies to identify, appraise and modify the use of social comparisons in ways that strengthen their self-esteem and other self-concepts, and thus reduce the risk of developing mental health problems. COPE specifically targets the use of social comparisons in four domains that are particularly salient and important for fostering the well-being of children. These include physical appearance, relationships with peers, physical activity and sport, and school achievement.

For the current project we will conduct a more extensive evaluation of the COPE program, with a particular focus on how it improves the mental health of 8 to 10 year old girls and boys. It is expected that children who participate in the COPE program will demonstrate increased positive affect, lower levels of negative affect, lower depressive and anxiety symptoms, higher levels of resiliency, and more positive self-concepts than a wait-list control group. The effectiveness of COPE will be evaluated at the completion of the program and also at five follow-up periods: 1-month, 6-months, 12-months, 18-months and 24-months post-intervention.


Trial website
Trial related presentations / publications
1. Prytula, E & Ricciardelli, LA (2014). School-based prevention and early-intervention of anxiety and depression in children.Paper presented at the International Congress of Applied Psychology, Paris, July 9-13.
2. Prytula, E (2015) Thesis entitled: School-Based Prevention of Anxiety and Depressive Symptoms in Children. Doctor of Psychology (Clinical), School of Psychology
3. Paper submitted for publication:
School-based program for anxiety and depression targeting
children’s use of social comparisons (available from lina@deakin.edu.au)
4. Paper in preparation:
Evaluation of an Early Intervention Program for Mental Health Problems Among Children
Using Growth Mixture Modelling (available from lina@deakin.edu.au)
Public notes

Contacts
Principal investigator
Name 30394 0
Prof Lina Ricciardelli
Address 30394 0
School of Psychology
Deakin University
Burwood 3125 Australia
Country 30394 0
Australia
Phone 30394 0
61 3 92446866
Fax 30394 0
Email 30394 0
lina@deakin.edu.au
Contact person for public queries
Name 13641 0
Prof Lina Ricciardelli
Address 13641 0
School of Psychology
Deakin University
Burwood Highway
Burwood VIC 3125
Country 13641 0
Australia
Phone 13641 0
61 3 92446866
Fax 13641 0
61 3 92446858
Email 13641 0
lina@deakin.edu.au
Contact person for scientific queries
Name 4569 0
Prof Lina Ricciardelli
Address 4569 0
School of Psychology
Deakin University
Burwood Highway
Burwood VIC 3125
Country 4569 0
Australia
Phone 4569 0
61 3 92446866
Fax 4569 0
61 3 92446858
Email 4569 0
lina@deakin.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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