Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001693415
Ethics application status
Approved
Date submitted
8/11/2016
Date registered
8/12/2016
Date last updated
8/12/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effectiveness of an intervention prompting kindness in order to boost children’s wellbeing and peer acceptance
Scientific title
Does kindness count? A randomized controlled trial on prosocial behaviour in relation to wellbeing and peer acceptance among Dutch children
Secondary ID [1] 290459 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Subjective wellbeing 300884 0
Peer acceptance 300885 0
Condition category
Condition code
Mental Health 300701 300701 0 0
Studies of normal psychology, cognitive function and behaviour
Public Health 300702 300702 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study examined the effectiveness of a four-week kindness intervention (based on the intervention of Layous and colleagues, 2012). After completing the baseline questionnaire (which happened in class during school hours), the primary investigator instructed children in the experimental condition to perform a minimum of three kind acts every Wednesday during the four-week intervention. Children were free to choose what kind acts they carried out and for whom (e.g., getting coffee for a teacher, lending a pencil to a classmate, or comforting a little brother). All children received a form (based on that of Layous and colleagues, 2012) including a description of what kind acts are, examples of kind acts, and the instruction to perform a minimum of three kind acts on Wednesday, which was read out loud by the primary investigator. Teachers were asked to help remind children about this by handing out the same instruction forms on Tuesday. Moreover, all children received a diary to keep track of the kind acts they performed. The diaries included detailed instructions on how to correctly report the kind acts. Every Thursday during the intervention, children were given the opportunity to fill in their diary during school hours. More specifically, they were asked to report the date, the type of kind act they performed, and the recipient of the kind act. The diaries were collected directly after the post-intervention questionnaire (i.e., 4 weeks after baseline).
Intervention code [1] 296352 0
Behaviour
Comparator / control treatment
Children in the control condition only completed the baseline and post-intervention questionnaires and did not receive an intervention (business-as-usual).
Control group
Active

Outcomes
Primary outcome [1] 300121 0
subjective wellbeing, indicated by happiness (i.e., sum score on the Subjective Happiness Scale adapted for children)
Timepoint [1] 300121 0
baseline and 4 weeks
Primary outcome [2] 300122 0
positive affect (i.e., sum score on the Positive and Negative Affect Schedule)
Timepoint [2] 300122 0
baseline and 4 weeks
Primary outcome [3] 300277 0
satisfaction with life (i.e., sum score on the Satisfaction with Life Scale adapted for children)
Timepoint [3] 300277 0
baseline and 4 weeks
Secondary outcome [1] 329104 0
PRIMARY OUTCOME
peer acceptance (i.e., standardized number of total nominations children received on the peer nomination question “who would you like to be in school activities with?” that children answered on a roster containing their classmates’ names; they were instructed to cross as few or many names as they liked or choose the option “nobody”)
Timepoint [1] 329104 0
baseline and 4 weeks
Secondary outcome [2] 329105 0
frequency of performing kind acts (i.e., children were asked “How often during the past four weeks did you perform a kind act for someone else?” on a 5-point scale ranging from 1 (never) to 5 (very often)).
Timepoint [2] 329105 0
baseline and 4 weeks
Secondary outcome [3] 329106 0
frequency of receiving kind acts (i.e., children were asked “How often during the past four weeks did someone else perform a kind act for you?” on a 5-point scale ranging from 1 (never) to 5 (very often)).
Timepoint [3] 329106 0
baseline and 4 weeks
Secondary outcome [4] 329107 0
experience of performing kind acts (i.e., children were asked “How much do you like to perform kind acts for others?” on a 7-point scale ranging from 1 (not at all) to 7 (very much)).
Timepoint [4] 329107 0
baseline and 4 weeks
Secondary outcome [5] 329587 0
general prosociality (i.e., sum score on the Prosocial Scale of the Strenghts and Difficulties Questionnaire)
Timepoint [5] 329587 0
baseline and 4 weeks
Secondary outcome [6] 329588 0
study appreciation (i.e., all children were asked “Did you like participating in this study?“ to which they could respond on a scale ranging from 1 (not at all) to 10 (very much)
Timepoint [6] 329588 0
4 weeks
Secondary outcome [7] 329589 0
study intervention appreciation (i.e., children in the experimental condition also indicated the extent to which they enjoyed performing kind acts for others (“How much did you like performing a minimum of three kind acts every Wednesday?“) on a scale ranging from 1 (not at all) to 10 (very much)).
Timepoint [7] 329589 0
4 weeks
Secondary outcome [8] 329590 0
study reporting appreciation (i.e., children in the experimental condition also indicated the extent to which they enjoyed writing the kind acts down in their diary (“How much did you like writing down the kind acts you performed every Thursday?“) on a scale ranging from 1 (not at all) to 10 (very much)).
Timepoint [8] 329590 0
4 weeks

Eligibility
Key inclusion criteria
Girls and boys from grades 7 and 8 of Dutch primary schools (9-13 years)
Children whose parents provided passive consent for their child to participate
Children that were willing and able to provide written consent
Minimum age
9 Years
Maximum age
13 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Schools that participated in a prosocial program during the past two years
Schools that participated in an anti-bullying program during the past two years

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Clusters of schools were allocated to either the experimental (kindness intervention) or the control condition (business-as-usual) by an independent researcher.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
After the headmasters provided active consent for the children from the fifth and sixth grade to participate, schools were randomized at school level to avoid contamination between conditions using simple randomization (coin tossing). To assure equal sample sizes across conditions, the primary investigator clustered the schools into two groups based on the number of students per school and grade level.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A power analysis using G*Power indicated that n = 90 per condition would suffice to detect a significant effect (a = .05) with power = .80. In order to compensate for potential dropouts we aimed to include 125 children per condition (N = 250). After contacting several schools throughout the Netherlands, 6 six schools expressed interested to take part in the study. Therefore, the total amount of children that were randomized and allocated to either one of the conditions was 490. The total number of children that actually participated in the study (after drop-outs) was 438.

To assess the effect of the kindness intervention on children’s wellbeing and peer acceptance, four mixed two-way repeated measures ANCOVAs (a = .05) with condition (experimental vs. control) and time (baseline vs. post-intervention) as independent variables were conducted. Positive affect, happiness, satisfaction with life, and peer acceptance were separately examined as dependent variables.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
27/11/2015
Date of last participant enrolment
Anticipated
Actual
27/11/2015
Date of last data collection
Anticipated
Actual
23/02/2016
Sample size
Target
250
Accrual to date
Final
438
Recruitment outside Australia
Country [1] 8380 0
Netherlands
State/province [1] 8380 0

Funding & Sponsors
Funding source category [1] 294912 0
University
Name [1] 294912 0
Radboud University
Country [1] 294912 0
Netherlands
Primary sponsor type
University
Name
Radboud University
Address
Comeniuslaan 4, 6525 HP Nijmegen
Postbus 9102, 6500 HC Nijmegen
Country
Netherlands
Secondary sponsor category [1] 293746 0
None
Name [1] 293746 0
Address [1] 293746 0
Country [1] 293746 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296289 0
Ethics Committee Faculty of Social Sciences, Radboud University
Ethics committee address [1] 296289 0
Ethics committee country [1] 296289 0
Netherlands
Date submitted for ethics approval [1] 296289 0
09/11/2015
Approval date [1] 296289 0
11/02/2016
Ethics approval number [1] 296289 0
ECSW2015-2311-360

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 70146 0
Miss Levie Karssen
Address 70146 0
Communication Science
Radboud University Nijmegen
P.O. Box 9104, 6500 HE Nijmegen, The Netherlands
Country 70146 0
Netherlands
Phone 70146 0
+310243612372
Fax 70146 0
Email 70146 0
[email protected]
Contact person for public queries
Name 70147 0
Levie Karssen
Address 70147 0
Communication Science
Radboud University Nijmegen
P.O. Box 9104, 6500 HE Nijmegen, The Netherlands
Country 70147 0
Netherlands
Phone 70147 0
+310243612372
Fax 70147 0
Email 70147 0
[email protected]
Contact person for scientific queries
Name 70148 0
Levie Karssen
Address 70148 0
Communication Science
Radboud University Nijmegen
P.O. Box 9104, 6500 HE Nijmegen, The Netherlands
Country 70148 0
Netherlands
Phone 70148 0
+310243612372
Fax 70148 0
Email 70148 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

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