Clinical trial NCT06419933: Emotional Problems in Preschool Children: Evaluation of the SuperKids Program (PRE-KIDS)
Official title: Prevention of Emotional Problems in Preschool Children Aged to 4 to 6 Years Old: Evaluation of the SuperKids Program (PRE-KIDS)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Emotional Problem
Keywords: Social skills
Emotional skills
Program evaluation
Preschool children
Lead sponsor: Universidad Miguel Hernandez de Elche
Sponsor class: OTHER
First posted: 2024-05-17
Enrollment: 500
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Cross-assignment. Participants who meet the inclusion criteria and undergo the full baseline assessment will be assigned to the intervention group condition or to the WLC group. Children assigned to the intervention condition will receive the eight-week intervention. Participants in the WLC group will not receive any psychological intervention during the eight-week program. Children and parents in all groups will complete the same set of measures at approximately the same time (pre-test and post-eight weeks). Children in the WLC group will receive the intervention after the follow-up visit is completed.
Primary purpose: PREVENTION

Brief summary: Emotional problems are among the most frequent psychological problems in the school stage, having an early onset. When they are not detected and they do not receive adequate intervention, they persist and become chronic, being considered precursors of other problems in adolescence and adulthood. The early onset of emotional problems, and their precursor role for other disorders, justify the need for preventive interventions as soon as possible. Since there is evidence that anxiety and depression share common underlying mechanisms, preventive programs should address shared risk factors. For this reason, the objective of this study is to test the effectiveness of an 8-session cognitive-behavioral protocol developed for Spanish children aged 4 to 6 in the educational context in a controlled trial. The objective of the program is that children improve their skills to manage their own emotions and to improve their ability to interact with other. The program will be applied ina group format and will be enriched with multimedia material that the implementer will project at various moments of the sessions.

Detailed description: A 2 x 3 factorial design will be used, with the intervention variable as an intergroup factor (intervention or waiting list), and with the evaluation phase as an intragroup factor (pretest, posttest, 12 months follow-up). Parents and children will complete the same measures at baseline, post-treatment, and follow-up. The investigators will compare the results of pre- and post-assessments of children participating in the program on emotional and social variables.

Eligibility criteria: Inclusion Criteria:

* Children aged 4 to 6 years.

Exclusion Criteria:

* Intellectual disability, behavioral symptoms or autistic spectrum symptoms whose severity prevented the continuation of treatment.
* Current psychological or pharmacological treatment for anxiety and/or depression.
* Not accepting or revoking informed consent to participate in the study.

Primary outcomes:
measure: The Kiddy-KINDL-R
timeFrame: Before starting the study
measure: The Kiddy-KINDL-R
timeFrame: Immediately after the intervention.
measure: The Kiddy-KINDL-R
timeFrame: 12 months after the intervention.
measure: Preschool Spence Anxiety Scale (PAS)
timeFrame: Before starting the study
measure: Preschool Spence Anxiety Scale (PAS)
timeFrame: Immediately after the intervention.
measure: Preschool Spence Anxiety Scale (PAS)
timeFrame: 12 months after the intervention.
measure: the Strengths and Difficulties Questionnaire
timeFrame: Before starting the study
measure: the Strengths and Difficulties Questionnaire
timeFrame: Immediately after the intervention.
measure: the Strengths and Difficulties Questionnaire
timeFrame: 12 months after the intervention.
measure: Behavioral Inhibition Questionnaire (BIQ
timeFrame: Before starting the study
measure: Behavioral Inhibition Questionnaire (BIQ
timeFrame: Immediately after the intervention.
measure: Behavioral Inhibition Questionnaire (BIQ
timeFrame: 12 months after the intervention.
measure: Parental Overprotection Scale
timeFrame: Baseline
measure: Depression Anxiety Stress Scales - short version (DASS-21)
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Elche
country: Spain
facility: Department of Health Psychology. Miguel Hernandez University of Elche Elche, Alicante, Spain, 03202
state: Alicante
Study officials:
affiliation: Universidad Miguel Hernandez de Elche
name: Mireia Orgilés Amorós
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bishop G, Spence SH, McDonald C. Can parents and teachers provide a reliable and valid report of behavioral inhibition? Child Dev. 2003 Nov-Dec;74(6):1899-917. doi: 10.1046/j.1467-8624.2003.00645.x.
citation: Orgiles M, Melero S, Penosa P, Espada JP, Morales A. [Parent-reported Health-Related Quality of Life in Spanish pre-schoolers: Psychometric properties of the Kiddy-KINDL-R]. An Pediatr (Engl Ed). 2019 May;90(5):263-271. doi: 10.1016/j.anpedi.2018.04.019. Epub 2018 Jul 6. Spanish.
citation: Orgiles M, Penosa P, Fernandez-Martinez I, Marzo JC, Espada JP. Spanish validation of the Spence Preschool Anxiety Scale. Child Care Health Dev. 2018 Sep;44(5):753-758. doi: 10.1111/cch.12593. Epub 2018 Jul 22.