Emotional ProblemNCT06419933
Emotional Problems in Preschool Children: Evaluation of the SuperKids Program (PRE-KIDS)
A study testing The SuperKids Program in people with Emotional Problem, run by Universidad Miguel Hernandez de Elche at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 6 years
- Conditions the study is for
- Emotional Problem
- What is being tested?
- The SuperKids Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteSpain
- Study dates
- 1 Nov 2023to 1 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 4 to 6 years.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Department of Health Psychology. Miguel Hernandez University of Elche Elche, Alicante, Spain, 03202
Elche, Alicante, 03202
Marina Serrano Ortiz, +34965222071, marina.serranoo@umh.es
Mireia Orgilés Amorós, +34 96 665 8348, maorgiles@umh.es
About this study
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.
Read the 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.
- Conditions
- Emotional Problem
- Being tested
- The SuperKids Program
- Keywords
- Social skills, Emotional skills, Program evaluation, Preschool children
- Medical subject headings
- Social Skills
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The SuperKids ProgramOther
The SuperKids program will be administered following the manual of the intervention by a trained therapist, as described in the section of intervention/ treatment
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: The SuperKids Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2024
- Study start1 Nov 2023
- Primary completion30 Jul 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Emotional ProblemStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Miguel Hernandez de Elche
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mireia Orgilés Amorós, Universidad Miguel Hernandez de Elche
- Investigators
- Mireia Orgilés Amorós, Principal investigator, Universidad Miguel Hernandez de Elche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06419933
- Sponsor's protocol ID
- PID2021-126473NB-I00
- Status last verified
- May 2024
- First submitted
- 8 May 2024
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 14669903Orgiles 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.
PubMed 31056090Orgiles 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.
PubMed 30033647
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Emotional Problems in Preschool Children Aged to 4 to 6 Years Old: Evaluation of the SuperKids Program (PRE-KIDS)
- ClinicalTrials.gov ID
- NCT06419933
- Acronym / sponsor ID
- PID2021-126473NB-I00
- Conditions
- Emotional Problem
- Keywords
- Social skills, Emotional skills, Program evaluation, Preschool children
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Universidad Miguel Hernandez de ElcheUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 30 Jul 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 17 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: The SuperKids ProgramSuperKids 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. |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children aged 4 to 6 years.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The SuperKids ProgramThe SuperKids program will be administered following the manual of the intervention by a trained therapist, as described in the section of intervention/ treatment | Other | Experimental group |
Primary outcome
The Kiddy-KINDL-R
Time frame: Before starting the study
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.
The Kiddy-KINDL-R
Time frame: Immediately after the intervention.
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.
The Kiddy-KINDL-R
Time frame: 12 months after the intervention.
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.
Preschool Spence Anxiety Scale (PAS)
Time frame: Before starting the study
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.
Preschool Spence Anxiety Scale (PAS)
Time frame: Immediately after the intervention.
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.
Preschool Spence Anxiety Scale (PAS)
Time frame: 12 months after the intervention.
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.
the Strengths and Difficulties Questionnaire
Time frame: Before starting the study
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.
the Strengths and Difficulties Questionnaire
Time frame: Immediately after the intervention.
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.
the Strengths and Difficulties Questionnaire
Time frame: 12 months after the intervention.
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.
Behavioral Inhibition Questionnaire (BIQ
Time frame: Before starting the study
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.
Behavioral Inhibition Questionnaire (BIQ
Time frame: Immediately after the intervention.
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.
Behavioral Inhibition Questionnaire (BIQ
Time frame: 12 months after the intervention.
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.
Parental Overprotection Scale
Time frame: Baseline
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).
Depression Anxiety Stress Scales - short version (DASS-21)
Time frame: Baseline
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Results publication: PubMed 14669903Bishop 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.
- Results publication: PubMed 31056090Orgiles 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.
- Results publication: PubMed 30033647Orgiles 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.
- Individual participant dataSharing planned: No
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Parent Intervention for Psychiatrically-Hospitalized Youth
Adolescent - Emotional Problem, Suicide and Self-harm
Not yet recruiting
Effectiveness of Internet-based Unified Protocol (iUP) for Emotional Problems: A Randomized Controlled Trial
Depression - Major Depressive Disorder, Generalised Anxiety Disorder
Active, not recruiting
Improving Student Mental Health Through a Universal Trauma-Informed Intervention
Anxiety Symptoms, Post-traumatic Stress Symptoms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mireia Orgilés Amorós principal investigator
Universidad Miguel Hernandez de Elche
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The SuperKids Program in people with Emotional Problem, run by Universidad Miguel Hernandez de Elche at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marina Serrano Ortiz (+34965222071, marina.serranoo@umh.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Kiddy-KINDL-R (time frame: Before starting the study). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06419933, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025.