Evaluation of the Effect of a Psychological Program for Children With Autism Spectrum Disorder and Feeding Difficulties

NCT06108583 | Recruiting

• 1 other identifier: PIC-151-17
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Autism Spectrum Disorder

Keywords

Autism; Feeding difficulties; Clinical trial; Intervention

Outcome Measures

Primary Outcomes (1)

• Change in Brief Assessment of Mealtime Behavior In Children (BAMBIC; Hendy et al. 2013).

  This questionnaire consists of 11 items that evaluate, on a 5-point Likert scale, three areas: limited variety, food refusal and disturbing behavior, in the last 6 months. Higher scores reflect more difficulties. The limited variety subscale assesses the child's willingness to try new foods or new types of preparation or textures. The food refusal subscale evaluates problem behaviors during meals, such as crying or closing his/her mouth tightly when food is presented. The disruptive behavior subscale includes items that assess aggressive behavior, self-injurious behaviors or disruptive conducts during meals, such as pushing or throwing utensils or food.

  Before and after intervention (12 weeks later)

Secondary Outcomes (2)

• Change in Parenting Stress Index, short version (PSI-SF; Abidin 1995).

  Before and after intervention (12 weeks later)

• Change in Qualitative questionnaire (ad hoc)

  Before and after intervention (12 weeks later)

Study Arms (2)

Experimental group

EXPERIMENTAL

The experimental group received intervention with TEAlimento program. The intervention combines parent training in both group and individual sessions, as well as group sessions with children. The program is made up of 12 sessions, focuses on parent training and uses video-modeling. Additionally, a post-group individual session is conducted three months after the intervention. Sessions are held weekly, combining group (1.5 h) with individual (1 h) sessions. During group sessions, caregivers attend a parent training session, which is focused on teaching strategies based on the principles of behavior intervention and specific techniques related to eating. Simultaneously, children attend a group session in a separate room to target sensory issues and receive oral-facial stimulation. Individual sessions are held only with caregivers in order to individualize strategies to target the needs of each child. Each group includes from 3 to 5 participants.

Behavioral: TEAlimento : a multicomponent parent training behavioral program to treat feeding difficulties in children with Autism Spectrum Disorder

Control group

NO INTERVENTION

The control group included participants in a waiting list. These families completed questionnaires at baseline and three months later (same time points as the experimental group), but they did not receive intervention during this period. Intervention was provided afterwards, but data after participating in the program was not included in this study.

Interventions

TEAlimento : a multicomponent parent training behavioral program to treat feeding difficulties in children with Autism Spectrum Disorder BEHAVIORAL

The program focuses on parent training. Additionally, intervention on sensory integration is implemented directly with children. The program is made up of 12 sessions, which are held weekly, combining group (1.5 hour parent training and child sensory desensitization) with individual sessions. Parent training group sessions (1,3,4,5,7,8), are focused on teaching strategies based on the principles of behavior intervention and specific techniques related to eating. Strategies involve functional behavioral assessment, antecedent-based interventions, extinction of disruptive behaviors, positive reinforcement, modeling and visual supports. Additionally, parents were trained in methods of introducing new foods, such as modifying food presentation or textures. Simultaneously, children attend a group session in a separate room to target sensory issues and receive oral-facial stimulation. Individual sessions (2,6,9) are focused on specific characteristics of each child.

Experimental group

Eligibility Criteria

• Age: 3 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• severe intellectual disability (intellectual or adaptive functioning below 35)
• severe behavioral problems
• medical risk situation that required more intensive intervention.

Sponsors & Collaborators

• Fundació Sant Joan de Déu: lead

Study Sites (1)

Department of Child and Adolescent Mental Health. Hospital Sant Joan de Déu

Esplugues de Llobregat, Barcelona, 08950, Spain

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Maria A Mairena, PhD

  Child and Adolescent Mental Health Research Group. Institut de Recerca Sant Joan de Déu. Spain

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria A Mairena, PhD

CONTACT

(0034) 93 253 21 00; mariaangeles.mairena@sjd.es

Mireia González, MS

CONTACT

(0034) 93 253 21 00; mireia.gonzalezr@sjd.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2023
• First Posted: October 31, 2023
• Study Start: January 10, 2018
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)