Behavioral program for children with autism and feeding difficulties
Evaluation of the Effectiveness of a Mixed (Multifamily Group) Psychological Intervention Program for Children With Autism Spectrum Disorder and Feeding Difficulties (ASD+FD)
NA · Fundació Sant Joan de Déu · NCT06108583
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 3 Years to 8 Years |
| Sex | All |
| Sponsor | Fundació Sant Joan de Déu (other) |
| Locations | 1 site (Esplugues de Llobregat, Barcelona) |
| Trial ID | NCT06108583 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are children aged 3-8 with a confirmed diagnosis of Autism Spectrum Disorder and significant feeding difficulties.
Not a fit: Patients with severe intellectual disabilities, severe behavioral problems, or those requiring more intensive medical interventions may not benefit from this program.
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 performed: While similar behavioral interventions have shown promise in addressing feeding difficulties in children with autism, this specific approach is relatively novel.
Eligibility criteria
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 this trial is running
Esplugues de Llobregat, Barcelona
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Autism Spectrum Disorder, Autism, Feeding difficulties, Clinical trial, Intervention