Clinical Trial of "Exploradores de Sabores" to Improve Food Selectivity in ASD Kids

Official title

A Clinical Trial of the "Exploradores de Sabores" Intervention to Improve Food Variety and Nutritional Status in Children With Autism Spectrum Disorder

Overview

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.

Interventions

• Behavioral Exploradores de Sabores Parent-Mediated Nutrition Intervention
  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 impleme
• Other Education as Usual (EAU)
  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 dietitia

Primary outcome measures

• Food Variety [Time frame: Baseline, mid-intervention, and immediately after completion of the 15-week intervention.]
• Nutritional status [Time frame: From enrollment to the end of treatment at 15 weeks]
• Food Neophobia [Time frame: Baseline and immediately after completion of the 15-week intervention.]

Secondary outcome measures (3)

• Food Selectivity [Time frame: Baseline and immediately after completion of the 15-week intervention.]
• Gastrointestinal health [Time frame: Baseline and immediately after completion of the 15-week intervention.]
• Caregiver Satisfaction with the Intervention [Time frame: At the end of the intervention, week 15]

Eligibility criteria

Inclusion criteria

• 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.
• Children with clinically significant food selectivity, as determined by AUT-EAT
• Children with malnutrition.

Exclusion criteria

• 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).
• Cases in which the parent or legal guardian attending the training sessions is not the individual responsible for implementing the intervention activities with the child at home.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Mexico · 1 center

• Facultad de Medicina y Psicología, UABC — Tijuana

Publications

• Vázquez FL, Torres Á, Otero P, Blanco V, Clifford Attkisson C. Psychometric properties of the Castilian Spanish version of the Client Satisfaction Questionnaire (CSQ-8). Curr Psychol. 2019;38(3):829-835. doi:10.1007/s12144-017-9641-2
• Aiemjoy K, Altan E, Aragie S, Fry DM, Phan TG, Deng X, Chanyalew M, Tadesse Z, Callahan EK, Delwart E, Keenan JD. Viral species richness and composition in young children with loose or watery stool in Ethiopia. BMC Infect Dis. 2019 Jan 14;19(1):53. doi: 10.1186/s12879-019-3674-3. PMID 30642268
• Galpin J, Osman L, Paramore C. Sensory snack time: a school-based intervention addressing food selectivity in autistic children. Front Educ. 2018;3:77. doi:10.3389/feduc.2018.00077
• Navarro-Gómez, N., & Trigueros-Ramos, R. (2025). Adaptación y validación española del AUT-EAT Questionnaire (AEQ). Revista de psicopatología y psicología clínica, 30(1), 49-59.
• Osorio-Alamillo Y, Fuentes-Cummings J, Ruiz-Barranco A, Bidart-Behar P, Clark P, Melendez-Mier G, Bueno Hernandez N. [Adaptation in Spanish and validation in Mexico of the Screening Tool for the Assessment of Malnutrition in Paediatrics (STAMP]. Nutr Hosp. 2023 Apr 20;40(2):354-361. doi: 10.20960/nh.04333. Spanish. PMID 36880722
• Damsbo-Svendsen M, Frost MB, Olsen A. Development of novel tools to measure food neophobia in children. Appetite. 2017 Jun 1;113:255-263. doi: 10.1016/j.appet.2017.02.035. Epub 2017 Feb 24. PMID 28242312
• Kennedy G, Ballard T, Dop M. Guía para medir la diversidad alimentaria a nivel individual y del hogar. Rome: FAO; 2019.
• Gray HL, Pang T, Agazzi H, Shaffer-Hudkins E, Kim E, Miltenberger RG, Waters KA, Jimenez C, Harris M, Stern M. A nutrition education intervention to improve eating behaviors of children with autism spectrum disorder: Study protocol for a pilot randomized controlled trial. Contemp Clin Trials. 2022 Aug;119:106814. doi: 10.1016/j.cct.2022.106814. Epub 2022 Jun 4. PMID 35671902

Identifiers

NCT: NCT07727018 · 0305_26-1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗