Autism Spectrum DisorderNCT05106166
Joint Attention-Based Occupational Therapy Intervention in Pre-Schoolers With Autism Spectrum Disorder
A study testing Occupational Therapy in people with Autism Spectrum Disorder and Social Communication, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
In order to support the development of preschool children, joint attention training with activities incorporated in their natural routines can support the achievement of occupational therapy goals. Read more about this study
- Who is it for?
- Ages 4 to 6 years
- Conditions the study is for
- Autism Spectrum Disorder, Social Communication, Behavior Problem
- What is being tested?
- Occupational Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2020to 5 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The study inclusion criteria were being between the ages of 4 and 6
- diagnosed with ASD
- consenting to participate in the study.
Who cannot join
- The study did not include children who had a co-morbid condition other than ASD
- had no previous education or training.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Joint Attention-Based Occupational Therapy Intervention in Pre-Schoolers With Autism Spectrum Disorder: A Randomized Controlled Trial
In order to support the development of preschool children, joint attention training with activities incorporated in their natural routines can support the achievement of occupational therapy goals. This study explores the adjunctive benefit of a joint attention-based occupational therapy program offered in addition to the usual special education program (USEP) compared to USEP alone.
The present study was designed as a randomized controlled study, including pre-post testing. The Social Communication Questionnaire (SCQ), Autism Behaviour Checklist (ABC), and A Motor-Free Visual Perception Test 4 (MVPT-4) were implemented to measure the participants' conditions before and after the intervention.
Read the detailed description
Twenty children, ten in each group, were included in the study. The study inclusion criteria were being between the ages of 4 and 6, diagnosed with ASD, and consenting to participate in the study. The study did not include children who had a co-morbid condition other than ASD and had no previous education or training. Between 1 April and 25 June 2020, a total of 28 children were interviewed for this study, and 3 children were excluded because they did not meet the inclusion criteria. 13 children were randomly assigned to the study group and 12 children to the control group. 3 individuals from the study group were excluded because of time, transportation or other reasons, and 2 children from the control group were excluded because they did not complete the assessments. As a result, a total of 20 children with ASD, 10 of whom were working and 10 were control, formed the sample group of the study. Informed consent was obtained after the scope and purpose of the study were explained in detail to the participants and primary family caregivers.
A social communication questionnaire (SCQ), autistic behavior checklist (ABC), and motor-free visual perception test-4 (MVPT-4) were administered to the children before and after the intervention, and the results were compared.
The SCQ was developed to evaluate the social communication of individuals with autism. The total score can be between 0-and 39 for children who can speak. The SCQ which comprises three sub-dimensions: reciprocal social interaction, language and communication, and repetitive and stereotyped patterns has the validity and reliability in Turkish.
The ABC is among the scales used for screening and evaluating education in autism in many countries. The ABC consists of five sub-dimensions: sensory, relating, body or object use, language, and social and self-help. The total score is between 0-159.
MVPT-4 is an instrument that presents a fast, reliable, and valid evaluation of children and adults' general and visual perceptual abilities. MVPT-4 consists of 45 items that are organized and grouped to provide a smooth implementation process. The items consist of black and white drawings and patterns developed to present answer options, making the implementation easy in a multiple-choice form. Motor skills are not necessary to get a response, which makes this test useful, especially for people with motor disabilities.
All children included in the study attend a usual special education program (USEP) 2 sessions per week in a rehabilitation center. The USEP studied was including gross motor skills, communication skills, preschool preparation skills, and self-care skills. The control group of the study consisted of children attending the USEP. Children in the study group received an occupational therapy intervention based on joint attention in addition to the USEP they continued. As an intervention in the study group, the sessions were conducted three days a week for a total of 12 weeks. The initial assessments were administered to children in both groups. At the end of the 12 weeks, the evaluations were repeated in both groups.
The acquisition frame of reference, which proposes to shape the behaviors that contribute to skill acquisition, and the developmental frame of reference, which emphasizes the continuous change and emergence of skills with age, guided the occupational therapy intervention. Therefore, all activities were designed according to the chronological and developmental ages of the children. During the joint attention-based intervention sessions, holistic occupational therapy approaches for the child's sensory, physical, social, language and communication deficits were discussed.
The steps followed are:
- Each parent was interviewed about the child's preferences. The toy types preferred by a child and the toys that a child might react negatively to were identified. The intervention specialist selected a total of 15 toys for paired stimulus preference assessments. Five of these toys were stuffed animals and figures. Five comprised multi-part activities, and the other five consisted of toys activated by light, movement, and/or sound. Each group of toys was used according to the child's interests and habits in three stages: creating a response to a joint attention offer, initiating joint attention, and reinforcing a joint attention response.
- During the joint attention-based occupational therapy intervention, researchers paid attention to maintaining eye contact and following the child's lead. Activities were conducted at the desk and on the floor. A game pattern was created using the selected toys; the pattern was planned and implemented as activities for an average of 20 minutes.
- In the sessions, (a) fine motor activities such as handicrafts, finger games; (b) gross motor activities such as obstacle course, music, dance; (c) visual-motor activities such as drawing, cutting, and assembly were used. Initiating and responding to joint attention during these activities was the focus of the intervention. With the training, the aim was to generalize behavioral skills and transfer them to the context of social play.
- It is stated that compatible environmental arrangements that will provide visual cues are important when structuring environmental activities because children with autism respond to the use of visual input. For this reason, environmental arrangements were made with visual stimuli that could attract a child's attention.
- Conditions
- Autism Spectrum Disorder, Social Communication, Behavior Problem, Visual Perceptual Weakness
- Being tested
- Occupational Therapy
- Medical subject headings
- Autism Spectrum Disorder, Communication, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occupational TherapyBehavioural
occupational therapy sessions are based on the joint attention
| Study group | Role | What they receive |
|---|---|---|
| Experimental group: occupational therapy program + the usual special education program (USEP) | Experimental | The practitioner used the less-to-more orientation to get the child to respond to the offer of joint attention. For example, if the child did not respond to the joint attention offer within 5-10 seconds, practitioner first directed the child, used exaggerated gestures, gave a moving hint if he still did not respond, and physically slowly directed the child's head towards the target if he still did not respond. In addition, the practitioner gave a verbal command (practitioner said: look at how his arms are waving, pointing to the toy, now look at me). When the child looked at the toy and reacted, he again gave enthusiastic and activity-appropriate feedback (e.g. he tickled the child, saying, "Isn't it weird, is there ever such a long arm?"). The child's interest and leadership in the activities were followed, including what the child did and said. Positive feedback was then provided. Receives: Behavioral: Occupational Therapy |
| Control group: the usual special education program (USEP) | Active comparator | The USEP studied was including gross motor skills, communication skills, preschool preparation skills, and self-care skills. The control group of the study consisted of children attending the USEP. Receives: Behavioral: Occupational Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Autistic Behavior Checklist (ABC)
The ABC is among the scales used for screening and evaluating education in autism in many countries. The ABC consists of five sub-dimensions: sensory, relating, body or object use, language, and social and self-help. The total score is between 0-159. Minimum score is 159. Maximum score is 0.
Measured: 12 weeks
Secondary outcomes (2)
Social Communication Questionnaire (SCQ)
The SCQ was developed to evaluate the social communication of individuals with autism. The total score can be between 0-and 39 for children who can speak. The SCQ which comprises three sub-dimensions: reciprocal social interaction, language and communication, and repetitive and stereotyped patterns. Minimum score is 39. Maximum score is 0.
Measured: 12 weeks
Motor-free Visual Perception Test-4 (MVPT-4)
MVPT-4 is an instrument that presents a fast, reliable, and valid evaluation of children and adults' general and visual perceptual abilities. MVPT-4 consists of 45 items that are organized and grouped to provide a smooth implementation process. The items consist of black and white drawings and patterns developed to present answer options, making the implementation easy in a multiple-choice form. Motor skills are not necessary to get a response, which makes this test useful, especially for people with motor disabilities. Maximum score is 45. Minimum score is 0.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start1 Apr 2020
- Primary completion2 Feb 2021
- Study completion5 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This prospective studies that measure the effectiveness of occupational therapy intervention. Randomized controlled trials (RCT) are prospective studies that measure the effectiveness of a new intervention or treatment. Participants are recruited and randomly assigned to either the intervention or the comparator group. It is important to ensure that at the time of recruitment there is no knowledge of which group the participant will be allocated to; this is known as concealment. It is examined whether there is any difference in the results of the study intervention and also the intervention and control group are compared.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sümeyye Belhan Çelik, Hacettepe University
- Investigators
- Sümeyye Belhan Çelik, PhD, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05106166
- Sponsor's protocol ID
- 2020/126
- Status last verified
- Nov 2021
- First submitted
- 22 Oct 2021
- Last updated
- 3 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It is not planned to be shared to protect the privacy of the clients, but it can only be shared with the editor or the referee of the submitted journal if they want to see it.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Joint Attention-Based Occupational Therapy Intervention in Pre-Schoolers With Autism Spectrum Disorder: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05106166
- Acronym / sponsor ID
- 2020/126
- Conditions
- Autism Spectrum Disorder, Social Communication, Behavior Problem, Visual Perceptual Weakness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 2 Feb 2021 (actual)
- Study completion
- 5 Jun 2021 (actual)
- First posted
- 3 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In order to support the development of preschool children, joint attention training with activities incorporated in their natural routines can support the achievement of occupational therapy goals. This study explores the adjunctive benefit of a joint attention-based occupational therapy program offered in addition to the usual special education program (USEP) compared to USEP alone.
The present study was designed as a randomized controlled study, including pre-post testing. The Social Communication Questionnaire (SCQ), Autism Behaviour Checklist (ABC), and A Motor-Free Visual Perception Test 4 (MVPT-4) were implemented to measure the participants' conditions before and after the intervention.
Detailed description
Twenty children, ten in each group, were included in the study. The study inclusion criteria were being between the ages of 4 and 6, diagnosed with ASD, and consenting to participate in the study. The study did not include children who had a co-morbid condition other than ASD and had no previous education or training. Between 1 April and 25 June 2020, a total of 28 children were interviewed for this study, and 3 children were excluded because they did not meet the inclusion criteria. 13 children were randomly assigned to the study group and 12 children to the control group. 3 individuals from the study group were excluded because of time, transportation or other reasons, and 2 children from the control group were excluded because they did not complete the assessments. As a result, a total of 20 children with ASD, 10 of whom were working and 10 were control, formed the sample group of the study. Informed consent was obtained after the scope and purpose of the study were explained in detail to the participants and primary family caregivers.
A social communication questionnaire (SCQ), autistic behavior checklist (ABC), and motor-free visual perception test-4 (MVPT-4) were administered to the children before and after the intervention, and the results were compared.
The SCQ was developed to evaluate the social communication of individuals with autism. The total score can be between 0-and 39 for children who can speak. The SCQ which comprises three sub-dimensions: reciprocal social interaction, language and communication, and repetitive and stereotyped patterns has the validity and reliability in Turkish.
The ABC is among the scales used for screening and evaluating education in autism in many countries. The ABC consists of five sub-dimensions: sensory, relating, body or object use, language, and social and self-help. The total score is between 0-159.
MVPT-4 is an instrument that presents a fast, reliable, and valid evaluation of children and adults' general and visual perceptual abilities. MVPT-4 consists of 45 items that are organized and grouped to provide a smooth implementation process. The items consist of black and white drawings and patterns developed to present answer options, making the implementation easy in a multiple-choice form. Motor skills are not necessary to get a response, which makes this test useful, especially for people with motor disabilities.
All children included in the study attend a usual special education program (USEP) 2 sessions per week in a rehabilitation center. The USEP studied was including gross motor skills, communication skills, preschool preparation skills, and self-care skills. The control group of the study consisted of children attending the USEP. Children in the study group received an occupational therapy intervention based on joint attention in addition to the USEP they continued. As an intervention in the study group, the sessions were conducted three days a week for a total of 12 weeks. The initial assessments were administered to children in both groups. At the end of the 12 weeks, the evaluations were repeated in both groups.
The acquisition frame of reference, which proposes to shape the behaviors that contribute to skill acquisition, and the developmental frame of reference, which emphasizes the continuous change and emergence of skills with age, guided the occupational therapy intervention. Therefore, all activities were designed according to the chronological and developmental ages of the children. During the joint attention-based intervention sessions, holistic occupational therapy approaches for the child's sensory, physical, social, language and communication deficits were discussed.
The steps followed are:
- Each parent was interviewed about the child's preferences. The toy types preferred by a child and the toys that a child might react negatively to were identified. The intervention specialist selected a total of 15 toys for paired stimulus preference assessments. Five of these toys were stuffed animals and figures. Five comprised multi-part activities, and the other five consisted of toys activated by light, movement, and/or sound. Each group of toys was used according to the child's interests and habits in three stages: creating a response to a joint attention offer, initiating joint attention, and reinforcing a joint attention response.
- During the joint attention-based occupational therapy intervention, researchers paid attention to maintaining eye contact and following the child's lead. Activities were conducted at the desk and on the floor. A game pattern was created using the selected toys; the pattern was planned and implemented as activities for an average of 20 minutes.
- In the sessions, (a) fine motor activities such as handicrafts, finger games; (b) gross motor activities such as obstacle course, music, dance; (c) visual-motor activities such as drawing, cutting, and assembly were used. Initiating and responding to joint attention during these activities was the focus of the intervention. With the training, the aim was to generalize behavioral skills and transfer them to the context of social play.
- It is stated that compatible environmental arrangements that will provide visual cues are important when structuring environmental activities because children with autism respond to the use of visual input. For this reason, environmental arrangements were made with visual stimuli that could attract a child's attention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- This prospective studies that measure the effectiveness of occupational therapy intervention. Randomized controlled trials (RCT) are prospective studies that measure the effectiveness of a new intervention or treatment. Participants are recruited and randomly assigned to either the intervention or the comparator group. It is important to ensure that at the time of recruitment there is no knowledge of which group the participant will be allocated to; this is known as concealment. It is examined whether there is any difference in the results of the study intervention and also the intervention and control group are compared.
| Arm | Type | Receives |
|---|---|---|
| Experimental group: occupational therapy program + the usual special education program (USEP) | Experimental | Behavioral: Occupational TherapyThe practitioner used the less-to-more orientation to get the child to respond to the offer of joint attention. For example, if the child did not respond to the joint attention offer within 5-10 seconds, practitioner first directed the child, used exaggerated gestures, gave a moving hint if he still did not respond, and physically slowly directed the child's head towards the target if he still did not respond. In addition, the practitioner gave a verbal command (practitioner said: look at how his arms are waving, pointing to the toy, now look at me). When the child looked at the toy and reacted, he again gave enthusiastic and activity-appropriate feedback (e.g. he tickled the child, saying, "Isn't it weird, is there ever such a long arm?"). The child's interest and leadership in the activities were followed, including what the child did and said. Positive feedback was then provided. |
| Control group: the usual special education program (USEP) | Active comparator | Behavioral: Occupational TherapyThe USEP studied was including gross motor skills, communication skills, preschool preparation skills, and self-care skills. The control group of the study consisted of children attending the USEP. |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- The study inclusion criteria were being between the ages of 4 and 6
- diagnosed with ASD
- consenting to participate in the study.
Key exclusion criteria (2 listed)
- The study did not include children who had a co-morbid condition other than ASD
- had no previous education or training.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Occupational Therapyoccupational therapy sessions are based on the joint attention | Behavioural | Control group: the usual special education program (USEP), Experimental group: occupational therapy program + the usual special education program (USEP) |
Primary outcome
Autistic Behavior Checklist (ABC)
Time frame: 12 weeks
The ABC is among the scales used for screening and evaluating education in autism in many countries. The ABC consists of five sub-dimensions: sensory, relating, body or object use, language, and social and self-help. The total score is between 0-159. Minimum score is 159. Maximum score is 0.
2 secondary outcomes
Social Communication Questionnaire (SCQ)
Time frame: 12 weeks
Motor-free Visual Perception Test-4 (MVPT-4)
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2021.
- Individual participant dataSharing planned: No. It is not planned to be shared to protect the privacy of the clients, but it can only be shared with the editor or the referee of the submitted journal if they want to see it.
Related trials for Autism Spectrum Disorder
Recruiting
Effectiveness of Clown Therapy in Facilitating Dental Visits for Children With Autism Spectrum Disorder
Autism Spectrum Disorder (ASD
Recruiting
Cerebellar Transcranial Direct Current Stimulation (tDCS) in Children With Autism Spectrum Disorder: Raynor Cerebellum Project
Autism Spectrum Disorder
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
Not yet recruiting
Transdiagnostic Sleep and Circadian Treatment for Autistic Adolescents
Sleep, Autism Spectrum Disorder
RecruitingObservational study
Effectiveness of the Autism Pupil Screen (APS) Detect Pupillometer for Identifying Autism Spectrum Disorder (ASD) in Routine Healthcare
Autism Spectrum Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sümeyye Belhan Çelik, PhD principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Occupational Therapy in people with Autism Spectrum Disorder and Social Communication, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Autistic Behavior Checklist (ABC) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2021.