Protocol summary

Summary
The current study is designed to construct Contextual Intervention manual based on Dunn's sensory processing framework and examine the effect on child participation and parent competency, among children with Autism Spectrum Disorders (ASD). The population of this study is all the families which have a child with ASD in Tehran. Participants are selected among families which refer to Nedaye-e-asr and Navid-e-asr rehabilitation centers regarding inclusion criteria and randomized through the list of the clients' names by taking every "K"th name. The assignment of centers to intervention/ control groups is randomized by closed pockets. 1)Base-line Phase: all participants are evaluated through Canadian Occupational Performance Measure (COPM) and Goal Attainment Scale (GAS) and Parent Self-efficiency Measure (PSEM), and during 4 weeks the participants receive the usual Occupational Therapy services, and then the evaluations repeat again. 2) Intervention Phase: The treatment group receives Contextual Interventions and usual Occupational Therapy (CI/OT) and the control group receives the usual Occupational Therapy services (OT) during 12 weeks. Contextual Interventions include 2 training group sessions and 10 individual coaching sessions. Then both groups are evaluated for the third time. 3) Follow up Phase: Both groups receive the usual occupational therapy services during 4 weeks, and then they are evaluated for the fourth time.

General information

Acronym
-
IRCT registration information
IRCT registration number: IRCT2016100330113N1
Registration date: 2017-03-24, 1396/01/04
Registration timing: prospective

Last update:
Update count: 0
Registration date
2017-03-24, 1396/01/04
Registrant information
Name
Zahra Pashazadeh Azari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7754 8496
Email address
zahrapashazadehazari@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, University of Social Welfare and Rehabilitation Sciences
Expected recruitment start date
2017-04-21, 1396/02/01
Expected recruitment end date
2017-05-22, 1396/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Designing protocol of Contextual Interventions based on Dunn’s model of sensory processing and the efficacy on child participation and parent competency among children with Autism Spectrum Disorder
Public title
The effect of Contextual Interventions based on Dunn's model of sensory processing on child participation and parent competency among children with Autism Spectrum Disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: families who have a child with ASD (based on the psychiatrist report in the rehabilitation center); age range of children 3 to 10 years; children have at least one sensory pattern outside typical; parents' education are at least diploma; parents' language abilities (well comprehension and expression of Persian); parents consent for participation in this research Exclusion Criteria: absence in training and treatment sessions (more than 2 sessions) - occurance of epilepsy during research period and 6 month before it.
Age
From 3 years old to 10 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 34
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Participants are selected regarding inclusion criteria and randomized through the list of the clients' names by taking every "K"th name. The assignment of centers to intervention/ control groups is randomized by closed pockets.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of University of Social Welfare and Rehablitation
Street address
Koodakyar Street, Danshjoo Boulevard, Velenjak Avenue
City
Tehran
Postal code
Approval date
2016-05-23, 1395/03/03
Ethics committee reference number
IR.USWR.REC.1395.189

Health conditions studied

1

Description of health condition studied
Autism Spectrum Disorder
ICD-10 code
F84.5
ICD-10 code description
autistic psychopathy

Primary outcomes

1

Description
child participation
Timepoint
4 weeks before intervention, before intervention, after intervention, 4 weeks after intervention
Method of measurement
Canadian Occupational Performence Measure, Goal Attainment Scale

Secondary outcomes

1

Description
Parent Competency
Timepoint
4 weeks before intervention, before intervention, after intervention, 4 weeks after intervention
Method of measurement
Parent Self- effciency Measure

Intervention groups

1

Description
Contextual Interventions: include 2 group sessions for sharing information, and 10 sessions for individual coaching. Occupational Therapy: include the usual occupational therapy interventions for children with ASD.
Category
Lifestyle

2

Description
Occupational Therapy: include occupational therapy interventions that are usual for children with ASD.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Nedaye-e-asr
Full name of responsible person
Zahra Pashazadeh Azari
Street address
No. 7, Eastern Hafez Street, Banihashem Avenue, Resalat Highway
City
Tehran

2

Recruitment center
Name of recruitment center
Navid-e-asr Rehabilitation Center
Full name of responsible person
Zahra Pashazadeh Azari
Street address
Erfanian Street, Molavi Cross, Vali-e-asr Avenue
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Dr. Hamid Reza Khankeh
Street address
Koodakyar Avenue., Daneshjoo Bl., Velenjak Street
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, University of Social Welfare and Rehabilitation Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Zahra Pashazadeh Azari
Position
PhD Student of Occupational Therapy
Other areas of specialty/work
Street address
Koodakyar Street, Daneshjoo Boulevard, Velenjak Avenue
City
Tehran
Postal code
Phone
+98 21 2218 0037
Fax
Email
zahrapashazadehazari@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Social Welfare and Rehabilitation
Full name of responsible person
Zahra Pashazadeh Azari
Position
PhD Student of Occupational Therapy
Other areas of specialty/work
Street address
Koodakyar Avenue, Daneshjoo Boulevard., Velenjak Street
City
Tehran
Postal code
Phone
+98 21 2218 0037
Fax
Email
zahrapashazadehazari@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Zahra Pashazadeh Azari
Position
PhD Student of Occupational Therapy
Other areas of specialty/work
Street address
Velenjak Avenue, Daneshjoo Boulevard, Koodakyar Street
City
Tehran
Postal code
1985713834
Phone
+98 21 2218 0037
Fax
+98 21 2218 0109
Email
zahrapashazadehazari@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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