Clinical trial NCT06108583: Evaluation of the Effect of a Psychological Program for Children With Autism Spectrum Disorder 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Autism
Feeding difficulties
Clinical trial
Intervention
Lead sponsor: Fundació Sant Joan de Déu
Sponsor class: OTHER
First posted: 2023-10-31
Enrollment: 30
Sex: ALL
Minimum age (years): 3
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Change in Brief Assessment of Mealtime Behavior In Children (BAMBIC; Hendy et al. 2013).
timeFrame: Before and after intervention (12 weeks later)
Secondary outcomes:
measure: Change in Parenting Stress Index, short version (PSI-SF; Abidin 1995).
timeFrame: Before and after intervention (12 weeks later)
measure: Change in Qualitative questionnaire (ad hoc)
timeFrame: Before and after intervention (12 weeks later)
Other outcomes:
Locations:
city: Esplugues De Llobregat
country: Spain
facility: Department of Child and Adolescent Mental Health. Hospital Sant Joan de Déu
state: Barcelona
Study officials:
affiliation: Child and Adolescent Mental Health Research Group. Institut de Recerca Sant Joan de Déu. Spain
name: Maria A Mairena, PhD
role: PRINCIPAL_INVESTIGATOR
References: