Clinical trial Recruiting at 1 site Interventional Ages 3 to 8

Behavioral program for children with autism and feeding difficulties

Official title: Evaluation of the Effectiveness of a Mixed (Multifamily Group) Psychological Intervention Program for Children With Autism Spectrum Disorder and Feeding Difficulties (ASD+FD)

Run by Fundació Sant Joan de Déu · NCT06108583 · Data updated 2026-11-12

This study is testing a new program to help children with autism aged 3-8 who have trouble eating, to see if it can make mealtimes easier and less stressful for both kids and their parents.

Quick facts

Study typeInterventional
Ages3 Years to 8 Years
SexAll
Enrollment30 (estimated)
SponsorFundació Sant Joan de Déu
Academic / other
Locations1 site (Esplugues de Llobregat, Barcelona)
StatusRecruiting
StartedJanuary 10, 2018
Main results expectedDecember 31, 2026
Study endsDecember 31, 2026
Registry record updatedApril 27, 2025
Trial IDNCT06108583 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are children aged 3-8 with a confirmed diagnosis of Autism Spectrum Disorder and significant feeding difficulties.

Probably not a fit

Patients with severe intellectual disabilities, severe behavioral problems, or those requiring more intensive medical interventions may not benefit from this program.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This project aims to develop and evaluate TEAlimento, a behavioral program designed for children aged 3-8 with Autism Spectrum Disorder (ASD) who experience feeding difficulties. The intervention includes both group and individual parent training sessions, as well as group sessions for the children. A randomized waitlist-controlled design will assess the program's effectiveness by comparing outcomes at baseline and three months post-intervention. Key indicators of success include reduced food rejection, decreased disruptive behavior during meals, and increased variety in foods accepted, along with a reduction in parent stress levels.

Why it matters

Potential benefit: If successful, this program could significantly improve mealtime behaviors and reduce stress for families of children with autism.

How similar studies have gone: While similar behavioral interventions have shown promise in addressing feeding difficulties in children with autism, this specific approach is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* age range between 3 and 8 years old
* 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 intellectual disability (intellectual or adaptive functioning below 35)
* severe behavioral problems
* medical risk situation that required more intensive intervention.

Where it's running

  • Department of Child and Adolescent Mental Health. Hospital Sant Joan de Déu
    Esplugues de Llobregat, Barcelona, Spain
    Recruiting

Study contacts

  • Principal investigator: Maria A Mairena, PhD — Child and Adolescent Mental Health Research Group. Institut de Recerca Sant Joan de Déu. Spain
  • Study coordinator: Maria A Mairena, PhD
  • Email: mariaangeles.mairena@sjd.es
  • Phone: (0034) 93 253 21 00

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.