Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-30 @ 10:01 AM
Study NCT ID:
NCT06419933
Status:
RECRUITING
Last Update Posted:
2025-04-08
First Post:
2024-05-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Emotional Problems in Preschool Children: Evaluation of the SuperKids Program (PRE-KIDS)
Sponsor:
Universidad Miguel Hernandez de Elche
Organization:
Study Overview
Official Title:
Prevention of Emotional Problems in Preschool Children Aged to 4 to 6 Years Old: Evaluation of the SuperKids Program (PRE-KIDS)
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: