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Autism Spectrum DisorderNCT06108583

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

A study testing TEAlimento : a multicomponent parent training behavioral program to treat feeding difficulties in children with Autism Spectrum Disorder in people with Autism Spectrum Disorder, run by Fundació Sant Joan de Déu at 1 site in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 3 to 8 years
Conditions the study is for
Autism Spectrum Disorder
What is being tested?
TEAlimento : a multicomponent parent training behavioral program to treat feeding difficulties in children with Autism Spectrum Disorder
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteSpain
Study dates
10 Jan 2018to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 8 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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).

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Spain1 site, 1 recruiting
  • Department of Child and Adolescent Mental Health. Hospital Sant Joan de Déu

    Esplugues de Llobregat, Barcelona, 08950

    Maria A Mairena, PhD, (0034) 93 253 21 00, mariaangeles.mairena@sjd.es

    Mireia González, MS, (0034) 93 253 21 00, mireia.gonzalezr@sjd.es

    Recruiting

Other trials in Spain

About this study

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)

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.

Read the detailed description

Feeding difficulties are frequent in children with Autism Spectrum Disorder (ASD). The first goal was to develop TEAlimento, a behavioral program for children ages 3-8 with ASD and feeding difficulties. The second goal was to conduct a pilot study to evaluate the effect of the program.

Design A randomized waitlist -controlled clinical trial was designed to evaluate the effect of the program. The study ompared the intervention condition at two time points: baseline and 3 months later (our intervention program consisted of 12 sessions with a frequency of one session per week).

Initial effectivity data will be evaluated through the following specific indicators: limited variety of food, food rejection, disturbing behavior during meals and parent stress. Questionnaires to assess eating behaviors and parent stress will be administered before and after the intervention. Additionally, the number of new foods and food categories accepted after the intervention will be quantified. 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.

After approval by the review board of the Research and Ethics Committee of the Hospital, participants were recruited by psychologists and psychiatrists from a Multidisciplinary Unit for Autism Spectrum Disorder of a Child and Adolescent Mental Health Service, in accordance with the 2000 Helsinki Declaration.

Instruments

Characterization measures In order to confirm the diagnosis of autism spectrum disorder, clinical interviews were conducted with parents and the Autism Diagnostic Observational Schedule-2 was administered to all participants. To be included in the study, a score above the ADOS-2 cut-off point was requested. Intellectual ability was measured with the Weschler Preschool and Primary Scale of Intelligence IV or the Weschler Intelligence Scale for Children V, according to age. Adaptative functioning was measured with the Vineland Scale-2. In order to obtain specific information related to the child's food history, an ad hoc food history record was also filled with parents.

Outcome measures

In order to obtain preliminary data of the effect of the program, different instruments were administered before and after the intervention:

  • Parenting Stress Index, short version (PSI).
  • Brief Assessment of Mealtime Behavior In Children (BAMBIC).
  • Qualitative questionnaire. To collect information about the amount of new accepted foods and new categories of food accepted before and after the intervention, the investigators conducted interviews with parents at the beginning of each session and filled a specific food questionnaire (ad hoc/qualitative data)., with different categories of food: dairy products (milk, cheese); eggs, meat and fish; vegetables (green beans, tomatoes, lettuce); fruit (apple, banana, almonds, peanuts); beans (lentils, beans) and cereals (rice, bread); pastry (croissants, cakes, chocolate); miscellany (mayonnaise, spicy, fritters, snacks); and drinks (juices, soft drinks, water). Additionally, the questionnaire registered the tastes that the child accepted (salty, sweet, acid or sour) and the accepted colors for meals (red, green, white).

Procedures

After receiving information about the study, parents provided signed consent. Included participants were invited to participate in the TEAlimento program, a behavioral program to treat feeding difficulties in children with ASD between 3 and 8 years of age. The intervention combines parent training in both group and individual sessions, as well as group sessions with children. The program includes behavioral techniques, such as functional behavioral assessment, antecedent-based interventions, extinction of disruptive behaviors during meals, positive reinforcement (praise, access to toys or engaging in preferred activities), modeling and visual supports. Additionally, parents were trained in methods of introducing new foods, such as modifying the bite size, food presentation or food texture. Parents also received information about recommended mealtime routines, such as structured time tables and calm environment during meals.

The program focuses on parent training and uses video-modeling. The program is made up of 12 intervention sessions, divided into three phases: functional assessment (3 sessions), direct intervention (8 sessions), and closing (1 session). In addition, this structure is complemented by an initial telephone evaluation and a pre-group group session with the caregiver. Additionally, a post-group individual session with the caregiver is conducted three months after the intervention.

Sessions are held weekly, combining group (1.5 h) with individual (1 h) sessions. During group sessions (sessions 1,3,4,5,7,8), caregivers attend a parent training session. Parent training is focused on teaching strategies based on the principles of behavior intervention, management of contingencies and specific techniques related to eating. Simultaneously, while parents receive this training, children attend a group session in a separate room to target sensory issues and receive oral-facial stimulation. Children work on sensory processing, playing with different types of sensory elements, trying to normalize their eating behavior and eating different kinds of food. Individual sessions (sessions 2,6,9) are held only with caregivers. These sessions are focused on specific characteristics and particular difficulties of each child, in order to individualize strategies to target the needs of each child.

For this study, each group included from 3 to 5 participants. Each group was conducted by either two psychologists or by one psychologist and a master degree student. The clinical team had large experience in interventions with ASD children. In order to ensure fidelity of implementation of the intervention, before each session, clinicians reviewed specific protocol instructions. By the end of each session, clinicians reviewed again the protocol, to ensure that the intervention was provided consistently as designed. Simultaneous group sessions with children were conducted by a mental health specialized nurse and the support of two master degree students.

Data Analysis The Statistical Package for the Social Sciences will be used for statistical analyses. Descriptive analyses will be conducted to characterize the sample. In order to evaluate whether there is a treatment effect on the feeding difficulties, a 2 X 2 (time x treatment group) ANOVA will be conducted for the following outcomes : limited variety of food, food rejection, disturbing behavior during meals, number of new foods and food category accepted and parent stress.

Being tested
TEAlimento : a multicomponent parent training behavioral program to treat feeding difficulties in children with Autism Spectrum Disorder
Keywords
Autism, Feeding difficulties, Clinical trial, Intervention
Medical subject headings
Autism Spectrum Disorder, Autistic Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    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.

Study groups in NCT06108583
Study groupRoleWhat they receive
Experimental groupExperimentalThe 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.
Receives: Behavioral: TEAlimento : a multicomponent parent training behavioral program to treat feeding difficulties in children with Autism Spectrum Disorder
Control groupNo interventionThe 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Before and after intervention (12 weeks later)

Secondary outcomes (2)
  1. Change in Parenting Stress Index, short version (PSI-SF; Abidin 1995).

    The PSI-SF includes three subscales, comprising 12 items each, rated from 1 to 5. The subscale Paternal Distress assesses the discomfort experienced by parents, such as poor sense of competence, lack of social support or depressive symptoms. The subscale Parent-Child Dysfunctional Interaction evaluates the degree in which the child meets the expectations that parents have and the reinforcement that the child offers to his/her parents. The subscale Difficult Child assesses the degree in which parents perceive how difficult it is to control their child, according to his/her behaviors. Finally, the instrument includes a total scale score, which is calculated by summing the three subscales' scores, ranging from 36 to 180. Scores of 90 or above may indicate a clinical level of stress.

    Measured: Before and after intervention (12 weeks later)

  2. Change in Qualitative questionnaire (ad hoc)

    To collect information about the amount of new accepted foods and new categories of food accepted before and after the intervention, we conducted interviews with parents at the beginning of each session and filled a specific food questionnaire (ad hoc/qualitative data)., with different categories of food: dairy products (milk, cheese); eggs, meat and fish; vegetables (green beans, tomatoes, lettuce); fruit (apple, banana, almonds, peanuts); beans (lentils, beans) and cereals (rice, bread); pastry (croissants, cakes, chocolate); miscellany (mayonnaise, spicy, fritters, snacks); and drinks (juices, soft drinks, water). Additionally, the questionnaire registered the tastes that the child accepted (salty, sweet, acid or sour) and the accepted colors for meals (red, green, white).

    Measured: Before and after intervention (12 weeks later)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Oct 2023
  2. Study start10 Jan 2018
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06108583
Sponsor's protocol ID
PIC-151-17
Status last verified
Apr 2025
First submitted
25 Oct 2023
Last updated
27 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing TEAlimento : a multicomponent parent training behavioral program to treat feeding difficulties in children with Autism Spectrum Disorder in people with Autism Spectrum Disorder, run by Fundació Sant Joan de Déu at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Maria A Mairena, PhD ((0034) 93 253 21 00, mariaangeles.mairena@sjd.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Brief Assessment of Mealtime Behavior In Children (BAMBIC; Hendy et al. 2013). (time frame: Before and after intervention (12 weeks later)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.

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