Clinical trial NCT05106166: Joint Attention-Based Occupational Therapy Intervention in Pre-Schoolers With Autism Spectrum Disorder
Official title: Joint Attention-Based Occupational Therapy Intervention in Pre-Schoolers With Autism Spectrum Disorder: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Social Communication
Behavior Problem
Visual Perceptual Weakness
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2021-11-03
Enrollment: 20
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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. 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:

1. 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.
2. 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.
3. 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.
4. 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.

Eligibility criteria: Inclusion Criteria:

* The study inclusion criteria were being between the ages of 4 and 6
* diagnosed with ASD
* consenting to participate in the study.

Exclusion Criteria:

* The study did not include children who had a co-morbid condition other than ASD
* had no previous education or training.

Primary outcomes:
measure: Autistic Behavior Checklist (ABC)
timeFrame: 12 weeks
Secondary outcomes:
measure: Social Communication Questionnaire (SCQ)
timeFrame: 12 weeks
measure: Motor-free Visual Perception Test-4 (MVPT-4)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
affiliation: Hacettepe University
name: Sümeyye Belhan Çelik, PhD
role: PRINCIPAL_INVESTIGATOR
References: