Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000765729
Ethics application status
Approved
Date submitted
19/05/2022
Date registered
30/05/2022
Date last updated
30/05/2022
Date data sharing statement initially provided
30/05/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Animal-Assisted Social and Emotional Learning Interventions in Schools
Scientific title
The impact of an animal-assisted social and emotional learning intervention within a mainstream primary school setting
Secondary ID [1] 305519 0
Nil known
Universal Trial Number (UTN)
Trial acronym
AAT SEL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Social and Emotional Learning
 323847 0
Mental health 323849 0
Social Connection 326104 0
Condition category
Condition code
Mental Health 321356 321356 0 0
Anxiety
Mental Health 321358 321358 0 0
Studies of normal psychology, cognitive function and behaviour
Mental Health 322691 322691 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of the research is to evaluate the impact of incorporating a therapy dog into a social and emotional learning (SEL) intervention in a mainstream primary school setting. The study will be a cluster-controlled trial. Pre-intervention, and post-intervention assessments will be administered as an evaluation of the intervention.

Participants will be primary school students from one mainstream school (with two colleges located on the same campus). They will be randomly allocated into one of three groups:
1. SEL Intervention
2. Therapy dog-assisted SEL Intervention
3. Control/waitlist group

The interventions will be facilitated by the researcher and provisional psychologists. The sessions will be 1 hour and run once a week for 12 sessions. All facilitators will be trained to facilitate the evidence-based SEL intervention and will receive a manual with activities. The researcher will adapt the SEL intervention to incorporate a therapy dog. The interventions will be run face to face in class groups within a mainstream school setting.
Fidelity will be assessed at every session by one of the provisional psychologists. Fidelity measures will be used for each intervention arm.

Adherence to the intervention will be monitored through attendance records, an observation checklist of a student's engagement in discussions, a review of the topic at the end of the lesson and a reflection activity at the end of the lesson.

Merrell's Strong Kids 3-5 Program was selected as the evidence-based SEL intervention. The program is prevention oriented, practical and feasible to implement in the classroom setting. The topics include: understanding your feelings, understanding other people's feelings, dealing with anger, how thoughts and feelings are connected, conflict resolution, healthy life habits and goal setting. The lessons will be delivered as interactive small group and class discussions, role plays and individual reflections. The program is sequenced, active, focused and explicit.

A professionally trained 5-year-old yellow Labrador will participate in the adapted SEL intervention. She has undergone therapy dog training with Lead the Way Institute.
The therapy dog-assisted SEL intervention includes regular interaction with the therapy dog during the sessions, recognising her emotions based on her body cues and signs, using scenario examples to include the therapy dog in discussions, role-playing situations where a child is scared of her or likes her and the different thoughts and actions, recognising the different behaviours of the therapy dog in different contexts and situations, discussions about how dogs show anger and their signs, involving the therapy dog in a conflict resolution scenario and how a dog can help with setting up healthy habits in different areas.

NB: See attached outline of the program with therapy dog adaptations
Intervention code [1] 321872 0
Behaviour
Intervention code [2] 321873 0
Treatment: Other
Intervention code [3] 321874 0
Lifestyle
Comparator / control treatment
Control group: No treatment/waitlist group
Comparison group: SEL intervention without the therapy dog

The post assessment data collection for the control group will occur 12 weeks after enrolment.

The control group will receive the dog-assisted SEL intervention following the post assessment data collection.
Control group
Active

Outcomes
Primary outcome [1] 329141 0
Change in score on Merrell’s Strong Kids Program Scale: Social and Emotional Learning knowledge
Timepoint [1] 329141 0
Pre-intervention
Post-intervention (at the end of the final session)
Follow-up (early 2023)
Primary outcome [2] 331158 0
Change in score for prosocial skills using the prosocial sub-scale from the Strengths and Difficulties Questionnaire (SDQ)
Timepoint [2] 331158 0
Pre-intervention
Post-intervention (at the end of the final session)
Follow-up (early 2023)
Secondary outcome [1] 401603 0
Change in score on Moods and Feelings Questionnaire (MFQ)- Short Form: Depression
Timepoint [1] 401603 0
Pre-intervention
Post-intervention (end of final session)
Follow-up (early 2023)
Secondary outcome [2] 406403 0
Change in score on Screener for Child Related Anxiety Disorders (SCARED): Anxiety
Timepoint [2] 406403 0
Pre-intervention
Post-intervention (at the end of the final session)
Follow-up (early 2023)
Secondary outcome [3] 406404 0
Relationship between score on Coleman Dog Attitude Scale (C-DAS) and engagement in intervention (using observation tool).
Timepoint [3] 406404 0
Pre-intervention
Post-intervention (at the end of the final session)
Secondary outcome [4] 406889 0
Change in score on Strengths and Difficulties Questionnaire (SDQ): internalising, externalising, prosocial behaviours
Timepoint [4] 406889 0
Pre-intervention
Post-intervention (at the end of the final session)
Follow-up (early 2023)

Eligibility
Key inclusion criteria
Children in a mainstream primary school setting.
No fear of dogs
Able to understand English
Able to understand and complete surveys
Minimum age
8 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Allergies to dogs
Phobias/fear of dogs

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)
Allocation is concealed. At each college, the teacher will randomly pick out a group allocation from a hat and their class will be allocated to one of the three groups.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Classes will be randomly assigned to each group at each college
A simple randomisation technique will be used where each teacher will pick out a group allocation from a hat.
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
G*Power was used to perform a power analysis to determine the number of participants required to detect a medium effect (.25) with power .80, alpha set to .05 and a correlation of .50 between pre and post intervention scores. The estimated sample size required for three groups and using four measures is 102 participants using MANOVA (repeated measures, between factors).
A Multivariate Analysis of Variance (MANOVA) will be used to compare the change scores on the measures within and between the groups. The independent variable will be the group and the dependent variables will be the change scores on the measures (social competence and mental health).
Statistical analysis will be performed using SPSS version 25.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
4/04/2022
Date of last participant enrolment
Anticipated
29/07/2022
Actual
Date of last data collection
Anticipated
28/02/2023
Actual
Sample size
Target
102
Accrual to date
128
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 36814 0
3978 - Clyde North

Funding & Sponsors
Funding source category [1] 309821 0
University
Name [1] 309821 0
Monash University
Country [1] 309821 0
Australia
Primary sponsor type
Individual
Name
Dr Christine Grove
Address
Monash University (Education Faculty)
29 Ancora Imparo Way
Clayton
Victoria 3800
Country
Australia
Secondary sponsor category [1] 310878 0
None
Name [1] 310878 0
Address [1] 310878 0
Country [1] 310878 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309564 0
Monash University Human Research Ethics Committee (MUHREC)
Ethics committee address [1] 309564 0
Ethics committee country [1] 309564 0
Australia
Date submitted for ethics approval [1] 309564 0
18/02/2022
Approval date [1] 309564 0
15/03/2022
Ethics approval number [1] 309564 0
24522

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

Contacts
Principal investigator
Name 114606 0
Dr Christine Grove
Address 114606 0
Monash University (Education Faculty)
29 Ancora Imparo Way
Clayton
Victoria 3800
Country 114606 0
Australia
Phone 114606 0
+61 3 9905 0803
Fax 114606 0
Email 114606 0
[email protected]
Contact person for public queries
Name 114607 0
Lena Wintermantel
Address 114607 0
Monash University (Education Faculty)
29 Ancora Imparo Way
Clayton
Victoria 3800
Country 114607 0
Australia
Phone 114607 0
+61 0402627930
Fax 114607 0
Email 114607 0
[email protected]
Contact person for scientific queries
Name 114608 0
Lena Wintermantel
Address 114608 0
Monash University (Education Faculty)
29 Ancora Imparo Way
Clayton
Victoria 3800
Country 114608 0
Australia
Phone 114608 0
+61 0402627930
Fax 114608 0
Email 114608 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Basic demographics
Individual outcomes measures
When will data be available (start and end dates)?
Immediately following publication and ending 2 years following main results publication
Available to whom?
Researchers who provide a methodologically sound proposal
Case-by-case basis at the discretion of Primary Investigator
Available for what types of analyses?
Case-by-case basis at the discretion of Primary Investigator
How or where can data be obtained?
Access subject to approval by key contact Lena Wintermantel ([email protected]) or primary investigator Dr Christine Grove ([email protected])


What supporting documents are/will be available?




Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.