Evaluation of the Effect of a Psychological Program for Children With Autism Spectrum Disorder and Feeding Difficulties
NCT ID: NCT06108583
Last Updated: 2025-04-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
30 participants
INTERVENTIONAL
2018-01-10
2026-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
It was hypothesized that the intervention would decrease food rejection and disruptive behavior during meals, as well as increase the number of foods tried. A decrease in parent stress was also expected.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluation of the Effect of a Social Skills Program for Children and Adolescents With ASD
NCT05713162
AUT-MENU: Improving Meal Experience of Subjects With Autism Spectrum Disorder
NCT06266377
Building Social Skills With Interdisciplinary Process Drama in ASD
NCT03536351
Digital-based Psychosocial Intervention for Parents of Children With Neurodevelopmental Disorders
NCT06303791
Impact of Nutritional Counselling in Children With Autism
NCT04652388
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Design A randomized waitlist -controlled clinical trial was designed to evaluate the effect of the program. The study ompared the intervention condition at two time points: baseline and 3 months later (our intervention program consisted of 12 sessions with a frequency of one session per week).
Initial effectivity data will be evaluated through the following specific indicators: limited variety of food, food rejection, disturbing behavior during meals and parent stress. Questionnaires to assess eating behaviors and parent stress will be administered before and after the intervention. Additionally, the number of new foods and food categories accepted after the intervention will be quantified. It was hypothesized that the intervention would decrease food rejection and disruptive behavior during meals, as well as increase the number of foods tried. A decrease in parent stress was also expected.
After approval by the review board of the Research and Ethics Committee of the Hospital, participants were recruited by psychologists and psychiatrists from a Multidisciplinary Unit for Autism Spectrum Disorder of a Child and Adolescent Mental Health Service, in accordance with the 2000 Helsinki Declaration.
Instruments
Characterization measures In order to confirm the diagnosis of autism spectrum disorder, clinical interviews were conducted with parents and the Autism Diagnostic Observational Schedule-2 was administered to all participants. To be included in the study, a score above the ADOS-2 cut-off point was requested. Intellectual ability was measured with the Weschler Preschool and Primary Scale of Intelligence IV or the Weschler Intelligence Scale for Children V, according to age. Adaptative functioning was measured with the Vineland Scale-2. In order to obtain specific information related to the child's food history, an ad hoc food history record was also filled with parents.
Outcome measures
In order to obtain preliminary data of the effect of the program, different instruments were administered before and after the intervention:
* Parenting Stress Index, short version (PSI).
* Brief Assessment of Mealtime Behavior In Children (BAMBIC).
* Qualitative questionnaire. To collect information about the amount of new accepted foods and new categories of food accepted before and after the intervention, the investigators conducted interviews with parents at the beginning of each session and filled a specific food questionnaire (ad hoc/qualitative data)., with different categories of food: dairy products (milk, cheese); eggs, meat and fish; vegetables (green beans, tomatoes, lettuce); fruit (apple, banana, almonds, peanuts); beans (lentils, beans) and cereals (rice, bread); pastry (croissants, cakes, chocolate); miscellany (mayonnaise, spicy, fritters, snacks); and drinks (juices, soft drinks, water). Additionally, the questionnaire registered the tastes that the child accepted (salty, sweet, acid or sour) and the accepted colors for meals (red, green, white).
Procedures
After receiving information about the study, parents provided signed consent. Included participants were invited to participate in the TEAlimento program, a behavioral program to treat feeding difficulties in children with ASD between 3 and 8 years of age. The intervention combines parent training in both group and individual sessions, as well as group sessions with children. The program includes behavioral techniques, such as functional behavioral assessment, antecedent-based interventions, extinction of disruptive behaviors during meals, positive reinforcement (praise, access to toys or engaging in preferred activities), modeling and visual supports. Additionally, parents were trained in methods of introducing new foods, such as modifying the bite size, food presentation or food texture. Parents also received information about recommended mealtime routines, such as structured time tables and calm environment during meals.
The program focuses on parent training and uses video-modeling. The program is made up of 12 intervention sessions, divided into three phases: functional assessment (3 sessions), direct intervention (8 sessions), and closing (1 session). In addition, this structure is complemented by an initial telephone evaluation and a pre-group group session with the caregiver. Additionally, a post-group individual session with the caregiver is conducted three months after the intervention.
Sessions are held weekly, combining group (1.5 h) with individual (1 h) sessions. During group sessions (sessions 1,3,4,5,7,8), caregivers attend a parent training session. Parent training is focused on teaching strategies based on the principles of behavior intervention, management of contingencies and specific techniques related to eating. Simultaneously, while parents receive this training, children attend a group session in a separate room to target sensory issues and receive oral-facial stimulation. Children work on sensory processing, playing with different types of sensory elements, trying to normalize their eating behavior and eating different kinds of food. Individual sessions (sessions 2,6,9) are held only with caregivers. These sessions are focused on specific characteristics and particular difficulties of each child, in order to individualize strategies to target the needs of each child.
For this study, each group included from 3 to 5 participants. Each group was conducted by either two psychologists or by one psychologist and a master degree student. The clinical team had large experience in interventions with ASD children. In order to ensure fidelity of implementation of the intervention, before each session, clinicians reviewed specific protocol instructions. By the end of each session, clinicians reviewed again the protocol, to ensure that the intervention was provided consistently as designed. Simultaneous group sessions with children were conducted by a mental health specialized nurse and the support of two master degree students.
Data Analysis The Statistical Package for the Social Sciences will be used for statistical analyses. Descriptive analyses will be conducted to characterize the sample. In order to evaluate whether there is a treatment effect on the feeding difficulties, a 2 X 2 (time x treatment group) ANOVA will be conducted for the following outcomes : limited variety of food, food rejection, disturbing behavior during meals, number of new foods and food category accepted and parent stress.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Experimental group
The experimental group received intervention with TEAlimento program. The intervention combines parent training in both group and individual sessions, as well as group sessions with children.
The program is made up of 12 sessions, focuses on parent training and uses video-modeling. Additionally, a post-group individual session is conducted three months after the intervention. Sessions are held weekly, combining group (1.5 h) with individual (1 h) sessions. During group sessions, caregivers attend a parent training session, which is focused on teaching strategies based on the principles of behavior intervention and specific techniques related to eating. Simultaneously, children attend a group session in a separate room to target sensory issues and receive oral-facial stimulation. Individual sessions are held only with caregivers in order to individualize strategies to target the needs of each child. Each group includes from 3 to 5 participants.
TEAlimento : a multicomponent parent training behavioral program to treat feeding difficulties in children with Autism Spectrum Disorder
The program focuses on parent training. Additionally, intervention on sensory integration is implemented directly with children. The program is made up of 12 sessions, which are held weekly, combining group (1.5 hour parent training and child sensory desensitization) with individual sessions. Parent training group sessions (1,3,4,5,7,8), are focused on teaching strategies based on the principles of behavior intervention and specific techniques related to eating. Strategies involve functional behavioral assessment, antecedent-based interventions, extinction of disruptive behaviors, positive reinforcement, modeling and visual supports. Additionally, parents were trained in methods of introducing new foods, such as modifying food presentation or textures. Simultaneously, children attend a group session in a separate room to target sensory issues and receive oral-facial stimulation. Individual sessions (2,6,9) are focused on specific characteristics of each child.
Control group
The control group included participants in a waiting list. These families completed questionnaires at baseline and three months later (same time points as the experimental group), but they did not receive intervention during this period.
Intervention was provided afterwards, but data after participating in the program was not included in this study.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
TEAlimento : a multicomponent parent training behavioral program to treat feeding difficulties in children with Autism Spectrum Disorder
The program focuses on parent training. Additionally, intervention on sensory integration is implemented directly with children. The program is made up of 12 sessions, which are held weekly, combining group (1.5 hour parent training and child sensory desensitization) with individual sessions. Parent training group sessions (1,3,4,5,7,8), are focused on teaching strategies based on the principles of behavior intervention and specific techniques related to eating. Strategies involve functional behavioral assessment, antecedent-based interventions, extinction of disruptive behaviors, positive reinforcement, modeling and visual supports. Additionally, parents were trained in methods of introducing new foods, such as modifying food presentation or textures. Simultaneously, children attend a group session in a separate room to target sensory issues and receive oral-facial stimulation. Individual sessions (2,6,9) are focused on specific characteristics of each child.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* confirmed diagnosis of cut-off at the Autism Diagnostic Observation Schedule-2 (ADOS-2, Lord et al., 2000)
* presence of significant feeding difficulties, defined as one or more of the following issues: significant food rejection, significant disruptive behavior at meals, significant selectivity based on type, texture, and presentation, and significant stress to family caused by these feeding difficulties.
* acquired oral-motor abilities to chew food
* accepts eating at least three foods (and a maximum of 20).
Exclusion Criteria
* severe behavioral problems
* medical risk situation that required more intensive intervention.
3 Years
8 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fundació Sant Joan de Déu
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Maria A Mairena, PhD
Role: PRINCIPAL_INVESTIGATOR
Child and Adolescent Mental Health Research Group. Institut de Recerca Sant Joan de Déu. Spain
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Department of Child and Adolescent Mental Health. Hospital Sant Joan de Déu
Esplugues de Llobregat, Barcelona, Spain
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PIC-151-17
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.