Autism Spectrum DisorderNCT06209463
Posture, Hand Functions and Sensory Processing Skills on Nutrition
An observational study of Autism Spectrum Disorder and Autism, run by Bezmialem Vakif University at 2 sites in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 5 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder, Autism, Autism, Mild
- How many people
- 80 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 20 Nov 2023to 4 Apr 2024
- How long will I take part?
- 1 Month
- Phase
- Observational
- 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 5 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: * Age between 5-10 years, * Diagnosis of Autism Spectrum Disorder (ASD), * Children scoring between 30-36.5 points on the Childhood Autism Rating Scale (CARS), * Absence of any oral structural disorders, * Willingness of the parent to voluntarily participate in the study
Who may be able to join
- Age between 5-10 years,
- Diagnosis of Autism Spectrum Disorder (ASD),
- Children scoring between 30-36.5 points on the Childhood Autism Rating Scale (CARS),
- Absence of any oral structural disorders,
- Willingness of the parent to voluntarily participate in the study.
Who cannot join
- Absence of physical, visual, and auditory impairments other than Autism Spectrum Disorder (ASD).
- Presence of any additional neurological, genetic, or metabolic disorders.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Bezmialem Vakıf University
Istanbul, Eyüp, 34050
Bezmialem Vakıf University
Istanbul
About this study
Official title: The Effect of Posture, Hand Functions and Sensory Processing Skills on Nutrition in Children With Autism Spectrum Disorder
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.
Read the detailed description
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.
- Conditions
- Autism Spectrum Disorder, Autism, Autism, Mild, ASD
- Keywords
- Autism Spectrum Disorder, posture, sensory processing, hand functions, nutrition
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study group | 40 children with autism underwent postural assessments, including measurement of craniovertebral angle (CVA) for head posture and Pediatric Balance Scale (PBS) for postural control; hand function assessments, including Jebsen Taylor Hand Function Test (JTHFT) for hand skills and Jamar hand dynamometer for hand grip strength; sensory processing assessments using Dunn Sensory Profile; nutrition problem assessments using the Screening Tool of Feeding Problems (STEP) and The Brief Autism Mealtime Behavior Inventory (BAMBI); and evaluation of life quality using the Pediatric Quality of Life Inventory-Parents Form (PedsQL-Parents Form). The Beck Depression Scale (BDI), Beck Anxiety Scale (BAI), and Trait-State Anxiety Scale were used to assess parents depression, anxiety, and anxiety status. | |
| Control group | 40 typically developing children (control group) underwent postural assessments, including measurement of craniovertebral angle (CVA) for head posture and Pediatric Balance Scale (PBS) for postural control; hand function assessments, including Jebsen Taylor Hand Function Test (JTHFT) for hand skills and Jamar hand dynamometer for hand grip strength; sensory processing assessments using Dunn Sensory Profile; nutrition problem assessments using the Screening Tool of Feeding Problems (STEP) and The Brief Autism Mealtime Behavior Inventory (BAMBI); and evaluation of life quality using the Pediatric Quality of Life Inventory-Parents Form (PedsQL-Parents Form). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Craniovertebral angle
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).
Measured: 2 weeks
Pediatric Balance Scale
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).
Measured: 2 weeks
Jebsen Taylor Hand Function Test
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.
Measured: 2 weeks
Jamar hand dynamometer
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.
Measured: 2 weeks
Dunn Sensory Profile
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).
Measured: 2 weeks
Screening Tool of Feeding Problems (STEP)
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).
Measured: 2 weeks
The Brief Autism Mealtime Behavior Inventory (BAMBI)
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).
Measured: 2 weeks
Pediatric Quality of Life Inventory-Parents Form
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.
Measured: 2 weeks
Beck Depression Scale
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.
Measured: 2 weeks
Beck Anxiety Scale
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.
Measured: 2 weeks
Trait-State Anxiety Scale
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).
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start20 Nov 2023
- Primary completion20 Mar 2024
- Study completion4 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University
- Responsible party
- Principal investigator, Elif Durgut, Bezmialem Vakif University
- Investigators
- YAĞMUR AYDOĞAN, Principal investigator, BEZMIALEM FOUNDATION UNIVERSITY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06209463
- Sponsor's protocol ID
- 5325597167
- Status last verified
- Sep 2025
- First submitted
- 5 Jan 2024
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Salahzadeh Z, Maroufi N, Ahmadi A, Behtash H, Razmjoo A, Gohari M, Parnianpour M. Assessment of forward head posture in females: observational and photogrammetry methods. J Back Musculoskelet Rehabil. 2014;27(2):131-9. doi: 10.3233/BMR-130426.
PubMed 23963268Weinstock-Zlotnick G, Mehta SP. A structured literature synthesis of wrist outcome measures: An evidence-based approach to determine use among common wrist diagnoses. J Hand Ther. 2016 Apr-Jun;29(2):98-110. doi: 10.1016/j.jht.2016.03.001.
PubMed 27264897Matson JL, Kuhn DE. Identifying feeding problems in mentally retarded persons: development and reliability of the screening tool of feeding problems (STEP). Res Dev Disabil. 2001 Mar-Apr;22(2):165-72. doi: 10.1016/s0891-4222(01)00065-8.
PubMed 11325163Margari L, Marzulli L, Gabellone A, de Giambattista C. Eating and Mealtime Behaviors in Patients with Autism Spectrum Disorder: Current Perspectives. Neuropsychiatr Dis Treat. 2020 Sep 11;16:2083-2102. doi: 10.2147/NDT.S224779. eCollection 2020.
PubMed 32982247Posar A, Visconti P. Sensory abnormalities in children with autism spectrum disorder. J Pediatr (Rio J). 2018 Jul-Aug;94(4):342-350. doi: 10.1016/j.jped.2017.08.008. Epub 2017 Nov 4.
PubMed 29112858Tsujiguchi H, Miyagi S, Nguyen TTT, Hara A, Ono Y, Kambayashi Y, Shimizu Y, Nakamura H, Suzuki K, Suzuki F, Nakamura H. Relationship between Autistic Traits and Nutrient Intake among Japanese Children and Adolescents. Nutrients. 2020 Jul 28;12(8):2258. doi: 10.3390/nu12082258.
PubMed 32731611Narzisi A, Fabbri-Destro M, Crifaci G, Scatigna S, Maugeri F, Berloffa S, Fantozzi P, Prato A, Muccio R, Valente E, Viglione V, Pecchini E, Pelagatti S, Rizzo R, Milone A, Barone R, Masi G. Sensory Profiles in School-Aged Children with Autism Spectrum Disorder: A Descriptive Study Using the Sensory Processing Measure-2 (SPM-2). J Clin Med. 2022 Mar 17;11(6):1668. doi: 10.3390/jcm11061668.
PubMed 35329994Matson ML, Matson JL, Beighley JS. Comorbidity of physical and motor problems in children with autism. Res Dev Disabil. 2011 Nov-Dec;32(6):2304-8. doi: 10.1016/j.ridd.2011.07.036. Epub 2011 Sep 3.
PubMed 21890317Nilsen AKO, Anderssen SA, Johannessen K, Aadland KN, Ylvisaaker E, Loftesnes JM, Aadland E. Bi-directional prospective associations between objectively measured physical activity and fundamental motor skills in children: a two-year follow-up. Int J Behav Nutr Phys Act. 2020 Jan 2;17(1):1. doi: 10.1186/s12966-019-0902-6.
PubMed 31898547Varni JW, Seid M, Kurtin PS. PedsQL 4.0: reliability and validity of the Pediatric Quality of Life Inventory version 4.0 generic core scales in healthy and patient populations. Med Care. 2001 Aug;39(8):800-12. doi: 10.1097/00005650-200108000-00006.
PubMed 11468499
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Posture, Hand Functions and Sensory Processing Skills on Nutrition in Children With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT06209463
- Acronym / sponsor ID
- 5325597167
- Conditions
- Autism Spectrum Disorder, Autism, Autism, Mild, ASD
- Keywords
- Autism Spectrum Disorder, posture, sensory processing, hand functions, nutrition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Collaborators
- Istanbul University
- Study start
- 20 Nov 2023 (actual)
- Primary completion
- 20 Mar 2024 (actual)
- Study completion
- 4 Apr 2024 (actual)
- First posted
- 17 Jan 2024 (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.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | – | –40 children with autism underwent postural assessments, including measurement of craniovertebral angle (CVA) for head posture and Pediatric Balance Scale (PBS) for postural control; hand function assessments, including Jebsen Taylor Hand Function Test (JTHFT) for hand skills and Jamar hand dynamometer for hand grip strength; sensory processing assessments using Dunn Sensory Profile; nutrition problem assessments using the Screening Tool of Feeding Problems (STEP) and The Brief Autism Mealtime Behavior Inventory (BAMBI); and evaluation of life quality using the Pediatric Quality of Life Inventory-Parents Form (PedsQL-Parents Form). The Beck Depression Scale (BDI), Beck Anxiety Scale (BAI), and Trait-State Anxiety Scale were used to assess parents depression, anxiety, and anxiety status. |
| Control group | – | –40 typically developing children (control group) underwent postural assessments, including measurement of craniovertebral angle (CVA) for head posture and Pediatric Balance Scale (PBS) for postural control; hand function assessments, including Jebsen Taylor Hand Function Test (JTHFT) for hand skills and Jamar hand dynamometer for hand grip strength; sensory processing assessments using Dunn Sensory Profile; nutrition problem assessments using the Screening Tool of Feeding Problems (STEP) and The Brief Autism Mealtime Behavior Inventory (BAMBI); and evaluation of life quality using the Pediatric Quality of Life Inventory-Parents Form (PedsQL-Parents Form). |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- * Age between 5-10 years, * Diagnosis of Autism Spectrum Disorder (ASD), * Children scoring between 30-36.5 points on the Childhood Autism Rating Scale (CARS), * Absence of any oral structural disorders, * Willingness of the parent to voluntarily participate in the study
Key inclusion criteria (5 listed)
- Age between 5-10 years,
- Diagnosis of Autism Spectrum Disorder (ASD),
- Children scoring between 30-36.5 points on the Childhood Autism Rating Scale (CARS),
- Absence of any oral structural disorders,
- Willingness of the parent to voluntarily participate in the study.
Key exclusion criteria (2 listed)
- Absence of physical, visual, and auditory impairments other than Autism Spectrum Disorder (ASD).
- Presence of any additional neurological, genetic, or metabolic disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Craniovertebral angle
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).
Pediatric Balance Scale
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).
Jebsen Taylor Hand Function Test
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.
Jamar hand dynamometer
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.
Dunn Sensory Profile
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).
Screening Tool of Feeding Problems (STEP)
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).
The Brief Autism Mealtime Behavior Inventory (BAMBI)
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).
Pediatric Quality of Life Inventory-Parents Form
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.
Beck Depression Scale
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.
Beck Anxiety Scale
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.
Trait-State Anxiety Scale
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).
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 26 Sep 2025.
- Results publication: PubMed 23963268Salahzadeh Z, Maroufi N, Ahmadi A, Behtash H, Razmjoo A, Gohari M, Parnianpour M. Assessment of forward head posture in females: observational and photogrammetry methods. J Back Musculoskelet Rehabil. 2014;27(2):131-9. doi: 10.3233/BMR-130426.
- Results publication: PubMed 27264897Weinstock-Zlotnick G, Mehta SP. A structured literature synthesis of wrist outcome measures: An evidence-based approach to determine use among common wrist diagnoses. J Hand Ther. 2016 Apr-Jun;29(2):98-110. doi: 10.1016/j.jht.2016.03.001.
- Results publication: PubMed 11325163Matson JL, Kuhn DE. Identifying feeding problems in mentally retarded persons: development and reliability of the screening tool of feeding problems (STEP). Res Dev Disabil. 2001 Mar-Apr;22(2):165-72. doi: 10.1016/s0891-4222(01)00065-8.
- Results publication: PubMed 32982247Margari L, Marzulli L, Gabellone A, de Giambattista C. Eating and Mealtime Behaviors in Patients with Autism Spectrum Disorder: Current Perspectives. Neuropsychiatr Dis Treat. 2020 Sep 11;16:2083-2102. doi: 10.2147/NDT.S224779. eCollection 2020.
- Results publication: PubMed 29112858Posar A, Visconti P. Sensory abnormalities in children with autism spectrum disorder. J Pediatr (Rio J). 2018 Jul-Aug;94(4):342-350. doi: 10.1016/j.jped.2017.08.008. Epub 2017 Nov 4.
- Results publication: PubMed 32731611Tsujiguchi H, Miyagi S, Nguyen TTT, Hara A, Ono Y, Kambayashi Y, Shimizu Y, Nakamura H, Suzuki K, Suzuki F, Nakamura H. Relationship between Autistic Traits and Nutrient Intake among Japanese Children and Adolescents. Nutrients. 2020 Jul 28;12(8):2258. doi: 10.3390/nu12082258.
- Results publication: PubMed 35329994Narzisi A, Fabbri-Destro M, Crifaci G, Scatigna S, Maugeri F, Berloffa S, Fantozzi P, Prato A, Muccio R, Valente E, Viglione V, Pecchini E, Pelagatti S, Rizzo R, Milone A, Barone R, Masi G. Sensory Profiles in School-Aged Children with Autism Spectrum Disorder: A Descriptive Study Using the Sensory Processing Measure-2 (SPM-2). J Clin Med. 2022 Mar 17;11(6):1668. doi: 10.3390/jcm11061668.
- Results publication: PubMed 21890317Matson ML, Matson JL, Beighley JS. Comorbidity of physical and motor problems in children with autism. Res Dev Disabil. 2011 Nov-Dec;32(6):2304-8. doi: 10.1016/j.ridd.2011.07.036. Epub 2011 Sep 3.
- Results publication: PubMed 31898547Nilsen AKO, Anderssen SA, Johannessen K, Aadland KN, Ylvisaaker E, Loftesnes JM, Aadland E. Bi-directional prospective associations between objectively measured physical activity and fundamental motor skills in children: a two-year follow-up. Int J Behav Nutr Phys Act. 2020 Jan 2;17(1):1. doi: 10.1186/s12966-019-0902-6.
- Results publication: PubMed 11468499Varni JW, Seid M, Kurtin PS. PedsQL 4.0: reliability and validity of the Pediatric Quality of Life Inventory version 4.0 generic core scales in healthy and patient populations. Med Care. 2001 Aug;39(8):800-12. doi: 10.1097/00005650-200108000-00006.
- Individual participant dataSharing planned: No
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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.
YAĞMUR AYDOĞAN principal investigator
BEZMIALEM FOUNDATION UNIVERSITY
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorder and Autism, run by Bezmialem Vakif University at 2 sites 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 5 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 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Craniovertebral angle (time frame: 2 weeks). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06209463, which also lists 10 linked publications.
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 26 Sep 2025.