Clinical Trial of "Exploradores de Sabores" to Improve Food Selectivity in ASD Kids
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-11
SponsorUniversidad Autonoma de Baja California
About this trial
The goal of this randomized, single-blind clinical trial is to evaluate the effectiveness of the Exploradores de Sabores parent-mediated nutrition intervention in reducing food selectivity and improving dietary variety, mealtime behaviors, nutritional status, and gastrointestinal symptoms among children aged 4 to 11 years with Autism Spectrum Disorder (ASD). The intervention consists of a standardized 15-week parent training program that combines nutrition education, behavioral feeding strategies, sensory-based approaches, and structured food exposure activities implemented by caregivers at home.
The main questions it aims to answer are:
* Does the Exploradores de Sabores intervention improve food selectivity and dietary variety in children with Autism Spectrum Disorder compared with Education as Usual (EAU)? * Does the intervention improve mealtime behaviors, nutritional status, and gastrointestinal symptoms compared with Education as Usual (EAU)?
Researchers will compare participants assigned to the Exploradores de Sabores intervention with those receiving Education as Usual (EAU) to determine whether the intervention results in greater improvements in food selectivity, dietary variety, mealtime behaviors, nutritional status, and gastrointestinal symptoms.
Participants will:
* Complete study assessments at baseline and immediately after completion of the 15-week intervention. * Be randomly assigned to either the Exploradores de Sabores intervention or the Education as Usual (EAU) control group. * If assigned to the intervention group, caregivers will participate in a standardized 15-week parent training program and implement structured home-based feeding activities using the intervention manual and educational materials. * If assigned to the Education as Usual (EAU) control group, caregivers will receive 15-week parent training in general recomendations that include healthy meal planning, hydration, and general guidance for promoting balanced eating habits. Children will undergo assessments of food selectivity, dietary variety, mealtime behaviors, nutritional status, and gastrointestinal symptoms at each study visit.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Children diagnosed with Autism Spectrum Disorder (ASD) requiring support levels 1, 2, or 3, without cognitive impairment.
Primary caregivers with sufficient availability to participate in and implement the intervention.
Children with or without mild functional gastrointestinal symptoms.
Children experiencing difficulties with the introduction or acceptance of new foods.
Disqualifiers
Current use of medications known to substantially affect appetite or feeding behavior (e.g., cyproheptadine, clonidine, or other appetite-modifying medications).
Syndromic Autism Spectrum Disorder (ASD).
Clinically significant gastrointestinal disorders requiring active medical treatment.
Medical conditions that significantly affect nutritional status, growth, or feeding behavior (e.g., phenylketonuria, cystic fibrosis, inflammatory bowel disease, endocrine disorders, or eating disorders).
Trial design
Design model
Parallel
Treatments tested in this trial
Exploradores de Sabores Parent-Mediated Nutrition Intervention
BehavioralThe Exploradores de Sabores intervention is a standardized, parent-mediated parent-mediated nutrition intervention designed to reduce food selectivity and improve dietary variety among children aged 4-11 years with Autism Spectrum Disorder (ASD). Parents participate in weekly group sessions led by a registered dietitian, combining nutrition education, responsive feeding strategies, sensory-based approaches, behavioral techniques, and gradual food exposure. Following each session, parents implement structured home-based activities using the intervention manual and educational materials, including repeated non-coercive food exposure, food play, sensory exploration, modeling, positive reinforcement, and mealtime environment modifications. The program consists of 15 weekly 40-minute sessions organized into an introductory session, three intervention phases, reinforcement sessions, and a final evaluation.
Education as Usual (EAU)
Other interventionParticipants assigned to the control group receive Education as Usual (EAU), consisting of general nutrition and healthy eating recommendations routinely provided to families of children with Autism Spectrum Disorder (ASD). Educational content includes national dietary recommendations, healthy meal planning, hydration, and general guidance for promoting balanced eating habits. To control for attention and contact time, participants attend 15 weekly 40-minute sessions led by a registered dietitian following the same schedule as the experimental group. However, they do not receive the behavioral feeding strategies, sensory-based approaches, or systematic food exposure techniques that are unique to the Exploradores de Sabores intervention. Families continue receiving their usual healthcare and educational services throughout the study.
Treatment groups
72 Participants
are divided into 2 treatment groupsGroup A: Exploradores de SaboresExperimental treatment 1 intervention
Group B: Education as Usual (EAU)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Food Variety
Dietary variety will be assessed using the Food Variety Questionnaire developed by the Food and Agriculture Organization (FAO). The questionnaire records foods consumed from predefined food groups over a specified reference period. A dietary variety score is calculated based on the number of different food groups consumed, Scores range from 0 to 16, corresponding to the number of food groups consumed. Higher scores indicate greater dietary variety and a better dietary outcome.The questionnaire will be completed by the child's primary caregiver.
Time frame
Baseline, mid-intervention, and immediately after completion of the 15-week intervention.2
Nutritional status
Nutritional status will be assessed using the Screening Tool for the Assessment of Malnutrition in Paediatrics (STAMP). STAMP evaluates nutritional risk based on the child's clinical diagnosis, recent nutritional intake, weight and height measurements, and anthropometric indicators. Scores range from 0 to 9. A score of 0-1 indicates low nutritional risk, 2-3 indicates medium risk, and ≥4 indicates high nutritional risk. Higher scores indicate a greater risk of malnutrition and therefore a worse outcome. Higher scores indicate a greater risk of malnutrition.
Time frame
From enrollment to the end of treatment at 15 weeks3
Food Neophobia
Food neophobia will be assessed using the Food Neophobia Test Tool, a validated caregiver-reported questionnaire that measures children's reluctance to try unfamiliar foods. The instrument uses a 7 Likert-type scale ranging from "Strongly disagree" to "Strongly agree," The total score ranges from 10 to 70, obtained by summing the responses to the 10 items after reverse-scoring the appropriate items. Higher scores indicate greater food neophobia and therefore a worse outcome.
Time frame
Baseline and immediately after completion of the 15-week intervention.Secondary outcomes
1
Food Selectivity
Food selectivity will be assessed using the Autism Eating Assessment Tool (AUT-EAT). The caregiver-reported questionnaire evaluates eating difficulties across multiple domains, including food selectivity, sensory sensitivity, mealtime behaviors, eating habits, and the impact of feeding difficulties on daily functioning. The questionnaire consists of 41 items rated on a 5-point Likert scale , The questionnaire comprises six factors: food Uniformity and Rituals: 12 items, overeating: 7 items, chewing and swallowing problems: 7 items, food selectivity: 7 items, problematic mealtime behaviors: 4 items and food avoidance: 3 items Parents rate each item using a 5-point Likert scale, ranging from 0 (never) to 5 (very frequently).with total scores ranging from 41 to 205. Higher scores indicate greater eating difficulties and more severe feeding-related problems; therefore, higher scores represent a worse outcome.
Time frame
Baseline and immediately after completion of the 15-week intervention.2
Gastrointestinal health
Gastrointestinal health will be assessed using the Bristol Stool Form Scale (BSFS), a validated 7-point visual scale that classifies stool consistency from Type 1 (hard stools) to Type 7 (watery stools). The BSFS is used to evaluate bowel habits and gastrointestinal function, with changes in stool consistency indicating improvements or alterations in gastrointestinal health.
Time frame
Baseline and immediately after completion of the 15-week intervention.3
Caregiver Satisfaction with the Intervention
Caregiver satisfaction with the intervention will be assessed using the Client Satisfaction Questionnaire (CSQ-8), an 8-item validated questionnaire that measures participants satisfaction with the services received. Each item is rated on a 4-point Likert scale. The total score ranges from 8 to 32, with higher scores indicating greater satisfaction with the intervention and therefore a better outcome..
Time frame
At the end of the intervention, week 15Sponsors and contacts
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Source ClinicalTrials.gov