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Comparison of the effectiveness of Animal-Assisted Therapy and Applied Behavior Analysis on Behaviors and Social Skills of Children with Autism Spectrum Disorder, a randomized controlled trial

Protocol summary

Study aim
the effectiveness of animal-assisted therapy in the main symptoms of autism spectrum disorders, namely communication, social skills, self-care behaviors, and reduction of repetitive and stereotyped behaviors.
Design
single blind randomized controlled trial
Settings and conduct
Children with level 1 autism spectrum disorders referring to the Child and Adolescent Psychiatry Clinic of Zare Hospital, Bu-Ali Sina Hospital, and Tooba Clinic in Sari will be selected. They will be randomly assigned to 4 groups: Group 1: Animal-based intervention (parrot), Group 2: Applied Behavior Analysis intervention, Group 3: Applied Behavior Analysis intervention with the passive presence of a pet, and Group 4: Waiting list without the presence of a pet. A demographic questionnaire (including age, gender, etc.) will be completed for all participants.
Participants/Inclusion and exclusion criteria
Study inclusion criteria: Having DSM-5 criteria for diagnosing autism spectrum disorder (KSADs interview) No other concomitant psychiatric disorders Having written parental and verbal consent from the child to participate in the study Study exclusion criteria Disagreement to continue participating in the study Emergence of parrot phobia Emergence of physical or mental conditions that prevent the study from continuing.
Intervention groups
Group 1: therapeutic intervention with an animal (parrot), Group 2: intervention using the applied behavior analysis method, Group 3: intervention with applied behavior analysis with the passive presence of a pet, Group 4: waiting list without the presence of a pet.
Main outcome variables
Signs and symptoms are assessed with the Aberrant Behavior Checklist-C and the Children's Social Skills Profile Questionnaire.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20121225011885N9
Registration date: 2025-03-21, 1404/01/01
Registration timing: registered_while_recruiting

Last update: 2025-03-21, 1404/01/01
Update count: 0
Registration date
2025-03-21, 1404/01/01
Registrant information
Name
Samaneh Farnia
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3328 5659
Email address
sfarnia@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-01-04, 1403/10/15
Expected recruitment end date
2025-05-05, 1404/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of Animal-Assisted Therapy and Applied Behavior Analysis on Behaviors and Social Skills of Children with Autism Spectrum Disorder, a randomized controlled trial
Public title
Effect of parrot in assissted treatment on autism
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
KSADS-PL SCREEN INTERVIEW: Autism Spectrum Disorders Absence of other concomitant psychiatric disorders Having written parental and verbal consent from the child to participate in the research No concomitant use of psychiatric medications
Exclusion criteria:
Unwillingness to continue participating in the study Occurrence of parrot phobia The occurrence of physical or mental conditions that prevent continued participation in the study.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
To randomly allocate subjects to either the four groups, the following steps will be undertaken in the current study: we need random numbers for 40 children in 4 intervention group (each group 10 participant) the numbers are generated by https://www.randomizer.org/ 4 data sets, 10 number per set, with unique numbers place markers within. The numbers 1 to 40 will correspond to the consecutive numbers of the referring patients based on the date of the medical record. (example: Set #1 p1=4, p2=16, p3=13, p4=22, p5=28, p6=33, p7=30, p8=36, p9=35, p10=21 Set #2 p1=21, p2=4, p3=40, p4=15, p5=3, p6=35, p7=34, p8=23, p9=37, p10=7 Set #3 p1=34, p2=28, p3=9, p4=40, p5=20, p6=36, p7=7, p8=3, p9=5, p10=2 Set #4 p1=10, p2=5, p3=38, p4=24, p5=27, p6=30, p7=25, p8=7, p9=36, p10=34)
Blinding (investigator's opinion)
Single blinded
Blinding description
regarding blinding procedures, Statistics expert colleague will be blind of intervention assigned.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Mazandaran University of Medical Sciences
Street address
Zare Sari Psychiatry and Burn Center,5th kilometer of Sari-Neka Road
City
sari
Province
Mazandaran
Postal code
۴۸۴۳۱۸۵۷۷۴
Approval date
2023-07-16, 1402/04/25
Ethics committee reference number
IR.MAZUMS.REC.1402.253

Health conditions studied

1

Description of health condition studied
Autism spectrum
ICD-10 code
autism
ICD-10 code description
autism spectrum

Primary outcomes

1

Description
Aberrant Behavior Checklist –C and Children's Social Skills Profile Questionnaire
Timepoint
All participants will be assessed immediately before the start of the study, at the end of the study (week 8), and 4 weeks after the end of the study.
Method of measurement
Aberrant Behavior Checklist –C and Children's Social Skills Profile Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Group 1: therapeutic intervention with a parrot
Category
Treatment - Other

2

Description
Intervention group: Group 2: intervention using the applied behavior analysis method
Category
Behavior

3

Description
Intervention group: Group 3: intervention using applied behavior analysis with the passive presence of a parrot
Category
Behavior

4

Description
Control group: waiting list
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Zare Hospital
Full name of responsible person
Samaneh Farnia
Street address
Zare Sari Psychiatry and Burn Center,5th kilometer of Sari-Naka road
City
Sari
Province
Mazandaran
Postal code
۴۸۴۳۱۸۵۷۷۴
Phone
+98 11 3328 4102
Email
sm.farnia@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Ahmad Ali Enayati
Street address
Deputy for Research and Technology Building,Moallem Square, sari town
City
Sari
Province
Mazandaran
Postal code
4817844718
Phone
+98 11 3325 7230
Email
ahmadali-enayati@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Samaneh Farnia
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Zare Sari Psychiatry and Burn Center,5th kilometer of Sari-Naka road
City
Sari
Province
Mazandaran
Postal code
۴۸۴۳۱۸۵۷۷۴
Phone
+98 11 3328 5659
Fax
+98 11 3328 5659
Email
sfarnia@mazums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Samaneh Farnia MD
Position
Psychiatrist/ Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Zare Hospital, Neka Road
City
Sari
Province
Mazandaran
Postal code
4815466848
Phone
+98 15 1222 4488
Fax
Email
sfarnia@mazums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Samaneh Farnia MD
Position
Psychiatrist/Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Zare Hospital, Neka Road
City
Sari
Province
Mazandaran
Postal code
4815466848
Phone
+98 911 156 1723
Fax
Email
sfarnia@mazums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
here is no further information
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Data will be made available to requesting researchers in an encrypted and non-identifiable form upon reasonable request from the principal investigator.
When the data will become available and for how long
6 months after publication
To whom data/document is available
this only available for people working in academic institutions
Under which criteria data/document could be used
Use for academic research with ethical approval
From where data/document is obtainable
contacting by E-mail
What processes are involved for a request to access data/document
sm.farnia@gmail.com
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