Intranasal Vasopressin Treatment in Children With Autism
NCT03204786
ASD, Autism
Stanford, California, United States
View Trial DetailsNCT Number: NCT06209463
To examine the effects of posture, hand functions and sensory processing skills on nutrition in children with autism spectrum disorder.
The study aims to include 40 children diagnosed with Autism Spectrum Disorder (ASD), directed from the Department of Child and Adolescent Psychiatry at Istanbul University, along with their parents/caregivers, and 40 healthy children along with their parents/caregivers.
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Notify Me5 year–10 year
All sexes
Observational
Bezmialem Vakıf University, Istanbul, Eyüp, Turkey (Türkiye)
Parents/caregivers of children diagnosed with ASD will be assessed using a demographic information form; sensory processing (Dunn Sensory Profile); nutrition (Screening Tool for Eating Problems (STEP), Brief Autism Mealtime Behavior Inventory (BAMBI)); quality of life (Pediatric Quality of Life Inventory (PedsQL 4.0)); children will undergo assessments for balance (Pediatric Berg Balance Scale); head posture (Craniovertebral angle method), hand functions (Jebsen Taylor Hand Function Test); grip strength (Jamar Hand Dynamometer); and parents' evaluations for depression, anxiety, and stress levels (Beck Depression Inventory, Beck Anxiety Inventory, Spielberger State-Trait Anxiety Inventory).
The assessment duration, including explanations and questionnaires, will take approximately 1 hour.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 2 weeks
The craniovertebral angle (CVA) measurement was used to evaluate the head posture of children. The CVA is formed by the angle created by the line connecting the midpoint of the tragus of the ear to the spinous process of C7. A marker was placed on the spinous process of C7 and the tragus. Children were instructed to move their heads up and down, gradually reducing this range of motion. After returning to their natural position, photographs were taken from the right side while looking at a fixed point to ensure correct posture. The photo was then loaded into computer software (MB Ruler 5.0), and the angle was calculated using a triangle ruler between the horizontal line passing through the C7 point and the line extending from the tragus to C7. A decrease in the CVA value (<50 degrees) indicates an increase in anterior head posture. A significant difference was found between the study and control groups in terms of CVA values, in favor of the control group (p<0.05).
Time frame: 2 weeks
Pediatric Balance Scale (PBS) was utilized to assess postural control in children. The PBS comprises 14 subdomains, including specific movements such as sitting, standing, turning, and reaching. Each subdomain receives a score between 0 and 4. The maximum achievable score is 56, and a higher score indicates better balance skills.
A significant difference in PBS scores was found between the study and control groups, favoring the control group (p<0.05).
Time frame: 2 weeks
Jebsen Taylor Hand Function Test (JTHFT) was used to measure children's hand functions. To conduct the JTHFT, the child was seated in front of the table where the test was administered. The test consists of seven tasks, including writing a 24-word sentence, flipping five cards, picking up small objects, mimicking eating with a teaspoon and five beans, stacking four checkers, picking up and carrying five large empty tin cans, and then picking up and carrying five large full tin cans. A longer duration to perform the tasks clinically indicates a poorer hand skill performance for the child.
A difference was found between the two groups in terms of all JTHFT subparameter values and handgrip strength values (p<0.05). It was observed that subjects with ASD took longer to perform all JTHFT subtests and had lower handgrip strength values.
Time frame: 2 weeks
The measurement of handgrip strength was conducted with the child sitting in a chair, the arm adhered to the body, shoulders in adduction, elbows in 90° flexion, and the forearm and wrist held in a neutral position using a Jamar hydraulic dynamometer with the dominant hand. The child was instructed to grasp the dynamometer firmly and then release it once. A total of 3 measurements were taken with 30-second rest intervals, including 5-second contraction periods. The grip strength values obtained were recorded in kilograms (kg) by taking the average.
A significant difference was found between the two groups in terms of hand grip strength values (p<0.05). Hand grip strength values were observed to be lower in patients with ASD.
Time frame: 2 weeks
Children's sensory processing skills were examined using the Turkish version of the Dunn Sensory Profile. The Dunn Sensory Profile questionnaire is filled out by parents/caregivers to assess the sensory processing skills of children aged 3-10. The questionnaire consists of three main sections. The first part measures children's responses to specific sensory inputs. The second part examines the ability of children to regulate sensory inputs to carry out daily life activities. The third part investigates the behavioral and emotional characteristics that arise when children process sensory information.
A difference was found between the study and control groups in terms of the Sensory Profile Scale subsection and total scores, in favor of the control group (p<0.05).
Time frame: 2 weeks
STEP is an instrument that focuses on specific sections by categorizing the occurring feeding problems, highlighting the section it concentrates on. It is a screening tool designed with 23 questions in a Likert-type format. The test contributes to identifying the most commonly observed problem by categorizing observed feeding problems in individuals.
A difference was found between the study and control groups in favor of the control group in all other STEP subgroup scores except for the 'aspiration risk' score (p<0.05).
Time frame: 2 weeks
BAMBI, developed by Lukens and Lischeid, was used to identify nutritional problems in children [138]. BAMBI consists of 18 items, each presenting 5 different options indicating the frequency of occurrence.An increase in the total score of BAMBI indicates a higher prevalence of specific negative behaviors related to Oral Sensory Processing.
A difference was found between the study and control groups in terms of BAMBI total score, with the difference favoring the control group (p<0.05).
Time frame: 2 weeks
This scale is a tool used to assess the overall quality of life of children and adolescents aged 2-18. It includes various subdomains such as physical health, emotional function, social function, and school function to measure the quality of life of individuals in different age groups. The higher the total score on Pediatric Quality of Life Inventory-Parents Form , the better the quality of life is perceived to be.
A difference was found between the study and control groups in terms of Pediatric Quality of Life Inventory-Parents Form subgroups and total scores, favoring the control group (p<0.05). Patients with ASD were observed to have lower Pediatric Quality of Life Inventory-Parents Form scores.
Time frame: 2 weeks
Parents' depression levels were examined using the Beck Depression Inventory (BDI). The BDI is a 21-item questionnaire that assesses the presence and severity of depression. In the scoring system, scores ranging from 0 to 9 indicate minimal depression, 10 to 18 suggest mild depression, 19 to 29 indicate moderate depression, and scores from 30 to 63 indicate severe depression, reflecting the level of depression.
A difference was found between the study and control groups in terms of BDI scores (p<0.05). It was observed that the parents of ASD patients had higher depression scores.
Time frame: 2 weeks
Parents' anxiety levels were assessed using the Beck Anxiety Inventory (BAI). The BAI is a brief 21-item questionnaire that evaluates the severity of anxiety. According to the scoring system, scores ranging from 0 to 9 indicate normal anxiety levels, 10 to 18 suggest mild to moderate anxiety, 19 to 29 indicate moderate to severe anxiety, and scores from 30 to 63 indicate a presence of very severe anxiety.
A difference was found between the study and control groups in terms of BAI scores (p<0.05). It was observed that the anxiety levels of the parents of the ASD patients were higher.
Time frame: 2 weeks
To assess the anxiety levels of parents, the State-Trait Anxiety Scale was utilized. This scale is a self-assessment questionnaire consisting of brief statements and provides a four-point Likert-type measurement. Evaluation is based on the responses of parents to questions that ask them to assess each situation. A score of 1 indicates that the specified situation does not reflect themselves at all, while a score of 4 indicates that the situation completely reflects themselves. In the State Anxiety Scale, responses indicate the intensity of emotion, thought, or behavior, while in the Trait Anxiety Scale, they are asked to specify the frequency of these elements. The total score from both inventories can range from 20 to 80. Higher scores represent higher levels of anxiety, while lower scores indicate lower levels of anxiety.
A difference was found between the study and control groups in terms of State-Trait Anxiety Scale scores (p<0.05).
Bezmialem Vakif University
Other
The Effect of Posture, Hand Functions and Sensory Processing Skills on Nutrition in Children With Autism Spectrum Disorder
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