Emotional Problems in Preschool Children: Evaluation of the SuperKids Program (PRE-KIDS)

NCT06419933 | Recruiting DMC

• 1 other identifier: PID2021-126473NB-I00
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Emotional Problem

Keywords

Social skills; Emotional skills; Program evaluation; Preschool children

Outcome Measures

Primary Outcomes (14)

• The Kiddy-KINDL-R

  Baseline level of physical and emotional well-being reported by parents as measured by the Kiddy-KINDL-R questionnaire. The Kiddy-KINDL-R measures assesses physical and emotional well-being of children aged 4 to 7 years across six dimensions: physical well-being, psychological well-being, self-esteem, family, social relationships, and school. Parents rate each item on a 5-point Likert scale: never (1), almost never (2), sometimes (3), almost always (4), and always (5). The total score is calculated by adding the scores for each dimension (range for each dimension: 4 to 20 points). Higher scores on each subscale and on the total scale indicate higher symptoms in children.

  Before starting the study

• The Kiddy-KINDL-R

  Level of physical and emotional well-being reported by parents immediately after the intervention measured by the Kiddy-KINDL-R questionnaire. The Kiddy-KINDL-R measures assesses physical and emotional well-being of children aged 4 to 7 years across six dimensions: physical well-being, psychological well-being, self-esteem, family, social relationships, and school. Parents rate each item on a 5-point Likert scale: never (1), almost never (2), sometimes (3), almost always (4), and always (5). The total score is calculated by adding the scores for each dimension (range for each dimension: 4 to 20 points). Higher scores on each subscale and on the total scale indicate higher symptoms in children.

  Immediately after the intervention.

• The Kiddy-KINDL-R

  Level of physical and emotional well-being reported by parents at 12 months Measured by the Kiddy-KINDL-R questionnaire. The Kiddy-KINDL-R measures assesses physical and emotional well-being of children aged 4 to 7 years across six dimensions: physical well-being, psychological well-being, self-esteem, family, social relationships, and school. Parents rate each item on a 5-point Likert scale: never (1), almost never (2), sometimes (3), almost always (4), and always (5). The total score is calculated by adding the scores for each dimension (range for each dimension: 4 to 20 points). Higher scores on each subscale and on the total scale indicate higher symptoms in children.

  12 months after the intervention.

• Preschool Spence Anxiety Scale (PAS)

  Baseline child-reported anxiety symptoms as measured by the Preschool Spence Anxiety Scale (PAS). The PAS measures symptom severity of DSMIV anxiety disorders in children (subscales: total, panic and agoraphobia, generalized anxiety disorder, obsessive-compulsive disorder, social phobia, separation anxiety, and specific fears). The frequency of symptoms is recorded on a 3-point Likert scale from 0 (never) to 3 (always). A minimum possible score of 0 and a maximum possible score of 114 is obtained. Higher scores indicate greater symptom severity. Higher scores indicate greater symptom severity.

  Before starting the study

• Preschool Spence Anxiety Scale (PAS)

  Anxiety symptoms reported by children immediately after the intervention measured using the Spence Preschool Anxiety Scale, (PAS). The PAS measures symptom severity of DSMIV anxiety disorders in children (subscales: total, panic and agoraphobia, generalized anxiety disorder, obsessive-compulsive disorder, social phobia, separation anxiety, and specific fears). The frequency of symptoms is recorded on a 3-point Likert scale from 0 (never) to 3 (always). A minimum possible score of 0 and a maximum possible score of 114 is obtained. Higher scores indicate greater symptom severity. Higher scores indicate greater symptom severity.

  Immediately after the intervention.

• Preschool Spence Anxiety Scale (PAS)

  Child-reported anxiety symptoms at 12 months Measured using the Spence Preschool Anxiety Scale (PAS). The PAS measures symptom severity of DSMIV anxiety disorders in children (subscales: total, panic and agoraphobia, generalized anxiety disorder, obsessive-compulsive disorder, social phobia, separation anxiety, and specific fears). The frequency of symptoms is recorded on a 3-point Likert scale from 0 (never) to 3 (always). A minimum possible score of 0 and a maximum possible score of 114 is obtained. Higher scores indicate greater symptom severity. Higher scores indicate greater severity of symptoms.

  12 months after the intervention.

• the Strengths and Difficulties Questionnaire

  Baseline Parent-reported depressive symptoms as measured by the Strengths and Difficulties Questionnaire, parent version (SDQ; Goodman, 1997). The SDQ measure examines emotional difficulties (5 items), conduct problems (5 items), hyperactivity (5 items), peer problems (5 items), and prosocial behavior (5 items) in children aged 3 to 16 years. Symptom frequency is recorded on a 3-point Likert scale from 0 (Not true) to 3 (Absolutely true). A minimum possible score of 0 and a maximum possible score of 114 is obtained. Higher scores indicate greater severity of symptoms. Higher scores indicate greater symptom severity.

  Before starting the study

• the Strengths and Difficulties Questionnaire

  Depressive symptoms reported by parents inmediately after intervention measured by the Strengths and Difficulties Questionnaire, parent version (SDQ; Goodman, 1997). The SDQ measure examines emotional difficulties (5 items), conduct problems (5 items), hyperactivity (5 items), peer problems (5 items), and prosocial behavior (5 items) in children aged 3 to 16 years. Symptom frequency is recorded on a 3-point Likert scale from 0 (Not true) to 3 (Absolutely true). A minimum possible score of 0 and a maximum possible score of 114 is obtained. Higher scores indicate greater severity of symptoms. Higher scores indicate greater symptom severity.

  Immediately after the intervention.

• the Strengths and Difficulties Questionnaire

  Depressive symptoms reported by parents at 12 months as measured by the Strengths and Difficulties Questionnaire, parent version (SDQ; Goodman, 1997). The SDQ measure examines emotional difficulties (5 items), conduct problems (5 items), hyperactivity (5 items), peer problems (5 items), and prosocial behavior (5 items) in children aged 3 to 16 years. Symptom frequency is recorded on a 3-point Likert scale from 0 (Not true) to 3 (Absolutely true). A minimum possible score of 0 and a maximum possible score of 114 is obtained. Higher scores indicate greater severity of symptoms. Higher scores indicate greater symptom severity.

  12 months after the intervention.

• Behavioral Inhibition Questionnaire (BIQ

  Baseline of children's behavioral inhibition measured using the Behavioral Inhibition Questionnaire (BIQ). The BIQ assesses the frequency of children's behavioral inhibition in six contexts across three domains: social novelty (unknown adults, peers, and performance in front of others), situational novelty (unfamiliar situations, preschool/separation), and novel physical activities with a possible risk of injury. This questionnaire has 30 items that are scored on a seven-point scale ranging from 1 (almost never) to 7 (almost always). Item scores are summed to create six scale scores: Unknown Peers, Unknown Adults, Performance Situations, Separation/Preschool, Unknown Situations, and Physically Challenging Situations.

  Before starting the study

• Behavioral Inhibition Questionnaire (BIQ

  Children's behavioral inhibition was immediately measured after the intervention using the Behavioral Inhibition Questionnaire (BIQ). The BIQ assesses the frequency of children's behavioral inhibition in six contexts across three domains: social novelty (unknown adults, peers, and performance in front of others), situational novelty (unfamiliar situations, preschool/separation), and novel physical activities with a possible risk of injury. This questionnaire has 30 items that are scored on a seven-point scale ranging from 1 (almost never) to 7 (almost always). Item scores are summed to create six scale scores: Unknown Peers, Unknown Adults, Performance Situations, Separation/Preschool, Unknown Situations, and Physically Challenging Situations.

  Immediately after the intervention.

• Behavioral Inhibition Questionnaire (BIQ

  Children's behavioral inhibition was measured at 12 months using the Behavioral Inhibition Questionnaire (BIQ). The BIQ assesses the frequency of children's behavioral inhibition in six contexts across three domains: social novelty (unknown adults, peers, and performance in front of others), situational novelty (unfamiliar situations, preschool/separation), and novel physical activities with a possible risk of injury. This questionnaire has 30 items that are scored on a seven-point scale ranging from 1 (almost never) to 7 (almost always). Item scores are summed to create six scale scores: Unknown Peers, Unknown Adults, Performance Situations, Separation/Preschool, Unknown Situations, and Physically Challenging Situations.

  12 months after the intervention.

• Parental Overprotection Scale

  Parental overprotective behavior is assessed with the Parental Overprotection Scale (OP, Edwards et al., 2008). POM evaluates, through 19 items, the overprotective behavior of parents towards their children, related in previous studies to anxiety in preschool children. Symptom frequency is recorded on a 3-point Likert scale, from 0 (not at all) to 4 (very much).

  Baseline

• Depression Anxiety Stress Scales - short version (DASS-21)

  Baseline parental depression, anxiety and stress symptoms Measured by the Depression Anxiety Stress Scales - short version (DASS-21). It contains a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress. Each of the three DASS-21 scales contains 7 items, divided into subscales with similar content. The depression scale assesses dysphoria, hopelessness, devaluation of life, self-deprecation, lack of interest / involvement, anhedonia and inertia. The anxiety scale assesses autonomic arousal, skeletal muscle effects, situational anxiety, and subjective experience of anxious affect. The stress scale is sensitive to levels of chronic nonspecific arousal. It assesses difficulty relaxing, nervous arousal, and being easily upset / agitated, irritable / over-reactive and impatient. Scores for depression, anxiety and stress are calculated by summing the scores for the relevant items.

  Baseline

Study Arms (2)

Control group wait-list

NO INTERVENTION

Group without any intervention. Participants in the wait-list group will receive no psychological intervention during the eight-week duration of the SuperKids program. Families will be informed that children in this group will receive the intervention once the follow-up is completed.

Experimental group

EXPERIMENTAL

SuperKids Structured and manualized intervention with a manual for the therapist and a workbook for the children. The intervention will be administered by SuperKids-trained clinical psychologists. Sessions will take place once a week for eight weeks, with each session lasting approximately forty-five minutes. The program includes emotional education and social skills training. These contents are learned through playful exercises, activities, readings and role-playing. The intervention modality will be face-to-face.

Other: The SuperKids Program

Interventions

The SuperKids Program OTHER

The SuperKids program will be administered following the manual of the intervention by a trained therapist, as described in the section of intervention/ treatment

Experimental group

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 4 to 6 years.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Miguel Hernandez de Elche: lead

Study Sites (1)

Department of Health Psychology. Miguel Hernandez University of Elche Elche, Alicante, Spain, 03202

Elche, Alicante, 03202, Spain

RECRUITING

Related Publications (3)

• 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.

  PMID: 14669903 BACKGROUND

• 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.

  PMID: 31056090 BACKGROUND

• 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.

  PMID: 30033647 BACKGROUND

MeSH Terms

Conditions

Social Skills

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Study Officials

• Mireia Orgilés Amorós

  Universidad Miguel Hernandez de Elche

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marina Serrano Ortiz

CONTACT

+34965222071; marina.serranoo@umh.es

Mireia Orgilés Amorós

CONTACT

+34 96 665 8348; morgiles@umh.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: 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.

Study Record Dates

• First Submitted: May 8, 2024
• First Posted: May 17, 2024
• Study Start: November 1, 2023
• Primary Completion: July 30, 2025
• Study Completion: August 1, 2025
• Last Updated: April 8, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)