NCT06108583Recruiting
Evaluation of the Effect of a Psychological Program for Children With Autism Spectrum Disorder 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)
Source: ClinicalTrials.gov · Last updated 27 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Feeding difficulties are frequent in children with Autism Spectrum Disorder (ASD). The main goal of this project was to develop TEAlimento, a behavioral program for children ages 3-8 with ASD and feeding difficulties. The intervention combines parent training in group and individual sessions, as well as group sessions with children. The second goal was to conduct a pilot study to evaluate the effect of the program. It was hypothesized that the intervention would decrease food rejection and disruptive behavior during meals, as well as increase the number of foods tried. A decrease in parent stress was also expected.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 25 Oct 2023
- Start date
- 10 Jan 2018
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Fundació Sant Joan de Déu
- Diseases
- Autism
- NCT number
- NCT06108583
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 10 Jan 2018 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- severe intellectual disability (intellectual or adaptive functioning below 35)
- severe behavioral problems
- medical risk situation that required more intensive intervention.
Who the study is looking for
- 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).
Age in the registry: 3 years to 8 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Child and Adolescent Mental Health. Hospital Sant Joan de Déu Coordinator of this site? Confirm its status | Esplugues de Llobregat | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.