An interventional study of Exploradores de Sabores Parent-Mediated Nutrition Intervention and Education as Usual (EAU) in Autism Spectrum Disorder and Food Selectivity, sponsored by Universidad Autonoma de Baja California. Recruiting at 1 site in Mexico. Open to participants aged 4 Years to 11 Years. Per ClinicalTrials.gov, last updated 2026-07-27.
Sponsored by Universidad Autonoma de Baja California · Not applicable, Interventional, and Treatment
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:
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:
1,724 studies on the registry are indexed under Autism Spectrum Disorder; 500 are open to participants now.
This study's planned enrollment of 72 is above the median of 52 across 1,368 interventional studies indexed under Autism Spectrum Disorder.
Browse Autism Spectrum Disorder studies →Universidad Autonoma de Baja California is the lead sponsor of 33 studies on the registry; 12 are open to participants now.
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Exclusion Criteria:
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Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Children aged 4-11 years with Autism Spectrum Disorder (ASD) who present food selectivity. Their parents or primary caregivers will participate in the Exploradores de Sabores parent-mediated nutrition intervention. The intervention consists of a standardized 15-week parent training program including nutrition education, behavioral feeding strategies, sensory-based approaches, and structured home-based food exposure activities.
Behavioral: Exploradores de Sabores Parent-Mediated Nutrition Intervention
Children aged 4-11 years with Autism Spectrum Disorder (ASD) and food selectivity whose parents or primary caregivers will continue receiving education and healthcare services as usual throughout the study. Participants will not receive the Exploradores de Sabores intervention but will continue receiving Education as Usual (EAU) throughout the study.
Other: Education as Usual (EAU)
The 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.
Participants 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.
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.
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 weeks
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.
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.
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.
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 15
Plan to share: No
Start is estimated for Aug 2026; primary completion for Dec 2026, 4 months later.
Of 800 non-industry interventional studies with no phase under Autism Spectrum Disorder, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 48. This study's planned 4 months is below that.
Counting every sponsor, half of 823 studies reached it within 25 months; a quarter within 12 and three quarters within 47.
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Universidad Autonoma de Baja California