Emotional Problem Clinical Trial
Official title:
Prevention of Emotional Problems in Preschool Children Aged to 4 to 6 Years Old: Evaluation of the SuperKids Program (PRE-KIDS)
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.
Status | Recruiting |
Enrollment | 500 |
Est. completion date | August 1, 2025 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 4 Years to 6 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Spain | Department of Health Psychology. Miguel Hernandez University of Elche Elche, Alicante, Spain, 03202 | Elche | Alicante |
Lead Sponsor | Collaborator |
---|---|
Universidad Miguel Hernandez de Elche |
Spain,
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. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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. | |
Primary | 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. | |
Primary | 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 | |
Primary | 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. | |
Primary | 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. | |
Primary | 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 | |
Primary | 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. | |
Primary | 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. | |
Primary | 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 | |
Primary | 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. | |
Primary | 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. | |
Primary | 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 | |
Primary | 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT03641664 -
FCT Study: Reducing the Need for Out-of-Home Placements
|
N/A | |
Recruiting |
NCT06228950 -
Mindfulness-Based Intervention for Emotional and Behavioural Problems of Students With Visual Impairment
|
N/A | |
Recruiting |
NCT06019429 -
Promoting Social-emotional Development and Self-esteem in Primary School Students
|
N/A | |
Completed |
NCT05499000 -
The Effect of Emotional Freedom Technique on Premenstrual Syndrome
|
N/A | |
Completed |
NCT04091633 -
School Health Implementation Network: Eastern Mediterranean
|
N/A | |
Completed |
NCT03060902 -
Preschooler Emotion Regulation in the Context of Maternal Borderline Personality Disorder
|
N/A | |
Recruiting |
NCT05280613 -
The Family Check-Up in Autism Services
|
N/A | |
Active, not recruiting |
NCT05082922 -
Implementation of the Hybrid Treatment in Clinical Care. A SCED.
|
N/A | |
Completed |
NCT04371263 -
How Dose Election Event Will Induce Emotion Change of Emergency Room and Critical Unit
|
||
Enrolling by invitation |
NCT04001140 -
Enhancement of Emotion Regulation Skills in Adolescents
|
N/A | |
Completed |
NCT04788901 -
Assessment of Emotion-regulation Skills in Game-based Situations
|
N/A | |
Completed |
NCT05424900 -
An Integrative Intervention for Preventing Children's Emotional Disorders
|
N/A | |
Completed |
NCT04949620 -
An Integrative Platform for Promoting Children's Emotional Health
|
N/A | |
Withdrawn |
NCT05739760 -
Impact of Cuddle and Calm Booklets on Parent-Child Emotional Connection a Nurture-based Children's Book
|
N/A | |
Recruiting |
NCT04298437 -
Addressing Depression and Positive Parenting Techniques (ADAPT)
|
N/A | |
Not yet recruiting |
NCT06302036 -
Emotional Freedom Techniques (EFT) on Stress, Anxiety and Depression in University Students Experiencing Earthquakes
|
N/A | |
Completed |
NCT04804917 -
3-year Follow-up of the Mind My Mind RCT
|
||
Recruiting |
NCT05295264 -
Active Pregnancy. Mental and Emotional Health Care to Pregnant Woman During and After Coronavirus (COVID-19)
|
N/A | |
Completed |
NCT05574569 -
Cognitive Behavior Play Therapy and Culturally Adapted Mindfulness-Based Guided Self-Help for Parents
|
N/A | |
Completed |
NCT05341297 -
A Transdiagnostic Internet Intervention for Parents of Children With Anxiety and Depressive Symptoms
|
N/A |