- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06444581
Effectiveness of the Universal Prevention Program Super Skills for Life in Schools
Prevention of Emotional Problems in Spanish School Children Aged 8 to 12 Years Old: Evaluation of the Super Skills for Life Program
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Alicante
-
Elche, Alicante, Spain, 03203
- Department of Health Psychology. Miguel Hernandez University of Elche
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Children aged 8 to 12 years.
- Be Spanish-speaking.
- Accepting informed consent to participate in the study.
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Group experimental
Super Skills intervention group: multimedia material version The Super Skills program will be administered following the manual of the intervention by a trained therapist, as described in the section of intervention/ treatment and will be enriched with multimedia material that the implementer will project at various moments of the sessions. Super Skills Structured and manualized intervention with a manual for the therapist and a workbook for the children. The intervention will be administered by Super Skills-trained clinical psychologists. Sessions will take place once a week for twelve weeks, with each session lasting approximately fifty 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. |
Super Skills Structured and manualized intervention with a manual for the therapist and a workbook for the children.
The intervention will be administered by Super Skills-trained clinical psychologists.
Sessions will take place once a week for twelve weeks, with each session lasting approximately fifty 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.
|
|
No Intervention: Group without any intervention
Participants in the wait-list group will receive no psychological intervention during the twelve-week duration of the Super Skills program.
Families will be informed that children in this group will receive the intervention once the posttest is completed.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Social Skills Questionnaire (SSQ) (Pupil Version)
Time Frame: Baseline
|
SSQ (Pupil Version) is a social skills assessment measure that focuses on a wide range of social behaviors in children aged 8-18.
Scoring the Social Skills Questionnaire (Youth): Scores are rated from 0 (Not true), through 1 (Sometimes true), to 2 (Mostly true).
The total score is computed by adding up the scores (0, 1, 2) for each item.
Total scores range from 0 to 60. Higher scores on this scale indicate higher social skills in children.
|
Baseline
|
|
Social Skills Questionnaire (SSQ) (Pupil Version)
Time Frame: Immediately after the intervention
|
SSQ (Pupil Version) is a social skills assessment measure that focuses on a wide range of social behaviors in children aged 8-18.
Scoring the Social Skills Questionnaire (Youth): Scores are rated from 0 (Not true), through 1 (Sometimes true), to 2 (Mostly true).
The total score is computed by adding up the scores (0, 1, 2) for each item.
Total scores range from 0 to 60. Higher scores on this scale indicate higher social skills in children.
|
Immediately after the intervention
|
|
Social Skills Questionnaire (SSQ) (Pupil Version)
Time Frame: 6 months after the intervention
|
SSQ (Pupil Version) is a social skills assessment measure that focuses on a wide range of social behaviors in children aged 8-18.
Scoring the Social Skills Questionnaire (Youth): Scores are rated from 0 (Not true), through 1 (Sometimes true), to 2 (Mostly true).
The total score is computed by adding up the scores (0, 1, 2) for each item.
Total scores range from 0 to 60. Higher scores on this scale indicate higher social skills in children.
|
6 months after the intervention
|
|
Social Skills Questionnaire (SSQ) (Pupil Version)
Time Frame: 12 months after the intervention
|
SSQ (Pupil Version) is a social skills assessment measure that focuses on a wide range of social behaviors in children aged 8-18.
Scoring the Social Skills Questionnaire (Youth): Scores are rated from 0 (Not true), through 1 (Sometimes true), to 2 (Mostly true).
The total score is computed by adding up the scores (0, 1, 2) for each item.
Total scores range from 0 to 60. Higher scores on this scale indicate higher social skills in children.
|
12 months after the intervention
|
|
The Positive and Negative Affect Schedule for Children-Short Form (PANAS-C-SF)
Time Frame: Baseline
|
PANAS-C-SF assesses two subscales in children aged 6 to 18 years: positive affect (joyful, lively, happy, energetic, and proud) and negative affect (angry, fearful/scared, afraid, and sad).
Responses are rated on a 5-point Likert scale ranging from 1 (very slightly or never) to 5 (very much).
|
Baseline
|
|
The Positive and Negative Affect Schedule for Children-Short Form (PANAS-C-SF)
Time Frame: Immediately after the intervention
|
PANAS-C-SF assesses two subscales in children aged 6 to 18 years: positive affect (joyful, lively, happy, energetic, and proud) and negative affect (angry, fearful/scared, afraid, and sad).
Responses are rated on a 5-point Likert scale ranging from 1 (very slightly or never) to 5 (very much).
|
Immediately after the intervention
|
|
The Positive and Negative Affect Schedule for Children-Short Form (PANAS-C-SF)
Time Frame: 6 months after the intervention
|
PANAS-C-SF assesses two subscales in children aged 6 to 18 years: positive affect (joyful, lively, happy, energetic, and proud) and negative affect (angry, fearful/scared, afraid, and sad).
Responses are rated on a 5-point Likert scale ranging from 1 (very slightly or never) to 5 (very much).
|
6 months after the intervention
|
|
The Positive and Negative Affect Schedule for Children-Short Form (PANAS-C-SF)
Time Frame: 12 months after the intervention
|
PANAS-C-SF assesses two subscales in children aged 6 to 18 years: positive affect (joyful, lively, happy, energetic, and proud) and negative affect (angry, fearful/scared, afraid, and sad).
Responses are rated on a 5-point Likert scale ranging from 1 (very slightly or never) to 5 (very much).
|
12 months after the intervention
|
|
Measured by the Cognitive Emotion Regulation Questionnaire (CERQ-k)
Time Frame: Baseline
|
CERQ-k consists of 36 items that measure nine cognitive coping strategies.
Each subscale represents one cognitive coping strategy: Self-blame, Other blame, Acceptance, Planning, Positive refocusing, Rumination or focus on thought, Positive reappraisal, Putting into perspective, and Catastrophizing.
The response format of the items is a five-point scale from (almost) never to (almost) always.
Each item is rated 1 to 5 points.
Minimum value 36 and maximum value 180.
|
Baseline
|
|
Measured by the Cognitive Emotion Regulation Questionnaire (CERQ-k)
Time Frame: Immediately after the intervention
|
CERQ-k consists of 36 items that measure nine cognitive coping strategies.
Each subscale represents one cognitive coping strategy: Self-blame, Other blame, Acceptance, Planning, Positive refocusing, Rumination or focus on thought, Positive reappraisal, Putting into perspective, and Catastrophizing.
The response format of the items is a five-point scale from (almost) never to (almost) always.
Each item is rated 1 to 5 points.
Minimum value 36 and maximum value 180.
|
Immediately after the intervention
|
|
Measured by the Cognitive Emotion Regulation Questionnaire (CERQ-k)
Time Frame: 6 months after the intervention
|
CERQ-k consists of 36 items that measure nine cognitive coping strategies.
Each subscale represents one cognitive coping strategy: Self-blame, Other blame, Acceptance, Planning, Positive refocusing, Rumination or focus on thought, Positive reappraisal, Putting into perspective, and Catastrophizing.
The response format of the items is a five-point scale from (almost) never to (almost) always.
Each item is rated 1 to 5 points.
Minimum value 36 and maximum value 180.
|
6 months after the intervention
|
|
Measured by the Cognitive Emotion Regulation Questionnaire (CERQ-k)
Time Frame: 12 months after the intervention
|
CERQ-k consists of 36 items that measure nine cognitive coping strategies.
Each subscale represents one cognitive coping strategy: Self-blame, Other blame, Acceptance, Planning, Positive refocusing, Rumination or focus on thought, Positive reappraisal, Putting into perspective, and Catastrophizing.
The response format of the items is a five-point scale from (almost) never to (almost) always.
Each item is rated 1 to 5 points.
Minimum value 36 and maximum value 180.
|
12 months after the intervention
|
|
Baseline children's reported anxiety symptoms. Measured by Spence Children's Anxiety Scale Child Report Short (SCAS-C-8)
Time Frame: Baseline
|
SCAS-C-8 measures symptoms severity of the DSMIV anxiety disorders in children.
Symptom frequency is recorded on a 3-point Likert scale from 0 (never) to 3 (always).
This yields a minimum possible score of 0 and a maximum possible score of 24.
Higher scores indicating greater severity of symptoms.
|
Baseline
|
|
Baseline children's reported anxiety symptoms. Measured by Spence Children's Anxiety Scale Child Report Short (SCAS-C-8)
Time Frame: Immediately after the intervention
|
SCAS-C-8 measures symptoms severity of the DSMIV anxiety disorders in children.
Symptom frequency is recorded on a 3-point Likert scale from 0 (never) to 3 (always).
This yields a minimum possible score of 0 and a maximum possible score of 24.
Higher scores indicating greater severity of symptoms.
|
Immediately after the intervention
|
|
Baseline children's reported anxiety symptoms. Measured by Spence Children's Anxiety Scale Child Report Short (SCAS-C-8)
Time Frame: 6 months after the intervention
|
SCAS-C-8 measures symptoms severity of the DSMIV anxiety disorders in children.
Symptom frequency is recorded on a 3-point Likert scale from 0 (never) to 3 (always).
This yields a minimum possible score of 0 and a maximum possible score of 24.
Higher scores indicating greater severity of symptoms.
|
6 months after the intervention
|
|
Baseline children's reported anxiety symptoms. Measured by Spence Children's Anxiety Scale Child Report Short (SCAS-C-8)
Time Frame: 12 months after the intervention
|
SCAS-C-8 measures symptoms severity of the DSMIV anxiety disorders in children.
Symptom frequency is recorded on a 3-point Likert scale from 0 (never) to 3 (always).
This yields a minimum possible score of 0 and a maximum possible score of 24.
Higher scores indicating greater severity of symptoms.
|
12 months after the intervention
|
|
Measured by Mood and Feelings Questionnaire - Short Version (MFQS)
Time Frame: Baseline
|
It assess depressive symptoms experienced in the past two weeks.
The MFQS provides an overall score (minimum value 0, maximum value 26).
Higher scores indicate more severe symptoms.
|
Baseline
|
|
Measured by Mood and Feelings Questionnaire - Short Version (MFQS)
Time Frame: Immediately after the intervention
|
It assess depressive symptoms experienced in the past two weeks.
The MFQS provides an overall score (minimum value 0, maximum value 26).
Higher scores indicate more severe symptoms.
|
Immediately after the intervention
|
|
Measured by Mood and Feelings Questionnaire - Short Version (MFQS)
Time Frame: 6 months after the intervention
|
It assess depressive symptoms experienced in the past two weeks.
The MFQS provides an overall score (minimum value 0, maximum value 26).
Higher scores indicate more severe symptoms.
|
6 months after the intervention
|
|
Measured by Mood and Feelings Questionnaire - Short Version (MFQS)
Time Frame: 12 months after the intervention
|
It assess depressive symptoms experienced in the past two weeks.
The MFQS provides an overall score (minimum value 0, maximum value 26).
Higher scores indicate more severe symptoms.
|
12 months after the intervention
|
|
Baseline level of physical and emotional well-being reported by children as measured by the KidKINDL_children questionnaire.
Time Frame: Baseline
|
The KidKINDL_children measures assess physical and emotional well-being of children aged 7 to 13 years across six dimensions: physical well-being, psychological well-being, self-esteem, family, social relationships, and school.
Children 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 lower symptoms in children.
|
Baseline
|
|
Level of physical and emotional well-being reported by children as measured by the KidKINDL_children questionnaire.
Time Frame: Immediately after the intervention
|
The KidKINDL_children measures assess physical and emotional well-being of children aged 7 to 13 years across six dimensions: physical well-being, psychological well-being, self-esteem, family, social relationships, and school.
Children 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 lower symptoms in children.
|
Immediately after the intervention
|
|
Level of physical and emotional well-being reported by children as measured by the KidKINDL_children questionnaire.
Time Frame: 6 months after the intervention
|
The KidKINDL_children measures assess physical and emotional well-being of children aged 7 to 13 years across six dimensions: physical well-being, psychological well-being, self-esteem, family, social relationships, and school.
Children 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 lower symptoms in children.
|
6 months after the intervention
|
|
Level of physical and emotional well-being reported by children as measured by the KidKINDL_children questionnaire.
Time Frame: 12 months after the intervention
|
The KidKINDL_children measures assess physical and emotional well-being of children aged 7 to 13 years across six dimensions: physical well-being, psychological well-being, self-esteem, family, social relationships, and school.
Children 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 lower symptoms in children.
|
12 months after the intervention
|
|
Self-Concept Form 5 (AF-5)
Time Frame: Baseline
|
It measures global satisfaction with self-concept (minimum value 0 and maximum value 120) and five dimensions (minimum value 0 and maximum value 24): Social (performance in social relationships); Academic/Professional (student/worker role); Emotional (perception of emotional state in general and in specific situations); Family (participation and integration into the family unit); and Physical self-concept (appearance and physical condition).
Higher scores indicate greater satisfaction with self-image.
|
Baseline
|
|
Self-Concept Form 5 (AF-5)
Time Frame: Immediately after the intervention
|
It measures global satisfaction with self-concept (minimum value 0 and maximum value 120) and five dimensions (minimum value 0 and maximum value 24): Social (performance in social relationships); Academic/Professional (student/worker role); Emotional (perception of emotional state in general and in specific situations); Family (participation and integration into the family unit); and Physical self-concept (appearance and physical condition).
Higher scores indicate greater satisfaction with self-image.
|
Immediately after the intervention
|
|
Self-Concept Form 5 (AF-5)
Time Frame: 6 months after the intervention
|
It measures global satisfaction with self-concept (minimum value 0 and maximum value 120) and five dimensions (minimum value 0 and maximum value 24): Social (performance in social relationships); Academic/Professional (student/worker role); Emotional (perception of emotional state in general and in specific situations); Family (participation and integration into the family unit); and Physical self-concept (appearance and physical condition).
Higher scores indicate greater satisfaction with self-image.
|
6 months after the intervention
|
|
Self-Concept Form 5 (AF-5)
Time Frame: 12 months after the intervention
|
It measures global satisfaction with self-concept (minimum value 0 and maximum value 120) and five dimensions (minimum value 0 and maximum value 24): Social (performance in social relationships); Academic/Professional (student/worker role); Emotional (perception of emotional state in general and in specific situations); Family (participation and integration into the family unit); and Physical self-concept (appearance and physical condition).
Higher scores indicate greater satisfaction with self-image.
|
12 months after the intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Child-Adolescent Perfectionism Scale (CAPS-S)
Time Frame: Baseline
|
CAPS-S is an instrument designed to assess perfectionism in a Spanish child population aged between 8 and 11.
It includes 13 items structured into 3 factors: Self-Oriented Perfectionism-Striving (SOP-Striving), Self-Oriented Perfectionism-Critical (SOP-Critical), and Socially Prescribed Perfectionism (SPP).
Items are rated using a 5-point scale ranging from 1 (False - Not at all true of me) to 5 (Very True of me).
Higher scores on this scale indicate higher levels of perfectionism in children.
|
Baseline
|
|
The Child-Adolescent Perfectionism Scale (CAPS-S)
Time Frame: Immediately after the intervention
|
CAPS-S is an instrument designed to assess perfectionism in a Spanish child population aged between 8 and 11.
It includes 13 items structured into 3 factors: Self-Oriented Perfectionism-Striving (SOP-Striving), Self-Oriented Perfectionism-Critical (SOP-Critical), and Socially Prescribed Perfectionism (SPP).
Items are rated using a 5-point scale ranging from 1 (False - Not at all true of me) to 5 (Very True of me).
Higher scores on this scale indicate higher levels of perfectionism in children.
|
Immediately after the intervention
|
|
The Child-Adolescent Perfectionism Scale (CAPS-S)
Time Frame: 6 months after the intervention
|
CAPS-S is an instrument designed to assess perfectionism in a Spanish child population aged between 8 and 11.
It includes 13 items structured into 3 factors: Self-Oriented Perfectionism-Striving (SOP-Striving), Self-Oriented Perfectionism-Critical (SOP-Critical), and Socially Prescribed Perfectionism (SPP).
Items are rated using a 5-point scale ranging from 1 (False - Not at all true of me) to 5 (Very True of me).
Higher scores on this scale indicate higher levels of perfectionism in children.
|
6 months after the intervention
|
|
The Child-Adolescent Perfectionism Scale (CAPS-S)
Time Frame: 12 months after the intervention
|
CAPS-S is an instrument designed to assess perfectionism in a Spanish child population aged between 8 and 11.
It includes 13 items structured into 3 factors: Self-Oriented Perfectionism-Striving (SOP-Striving), Self-Oriented Perfectionism-Critical (SOP-Critical), and Socially Prescribed Perfectionism (SPP).
Items are rated using a 5-point scale ranging from 1 (False - Not at all true of me) to 5 (Very True of me).
Higher scores on this scale indicate higher levels of perfectionism in children.
|
12 months after the intervention
|
|
Baseline level of physical and emotional well-being reported by parents as measured by the Kid_KiddoKINDL-R questionnaire
Time Frame: Baseline
|
The Kid_KiddoKINDL-R measures assess physical and emotional well-being of children aged 7 to 17 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 lower symptoms in children
|
Baseline
|
|
Level of physical and emotional well-being reported by parents immediately after the intervention measured by the Kid_KiddoKINDL-R questionnaire
Time Frame: Immediately after the intervention
|
The Kid_KiddoKINDL-R measures assess physical and emotional well-being of children aged 7 to 17 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 lower symptoms in children
|
Immediately after the intervention
|
|
Level of physical and emotional well-being reported by parents 6 months after the intervention measured by the Kid_KiddoKINDL-R questionnaire
Time Frame: 6 months after the intervention
|
The Kid_KiddoKINDL-R measures assess physical and emotional well-being of children aged 7 to 17 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 lower symptoms in children
|
6 months after the intervention
|
|
. Level of physical and emotional well-being reported by parents at 12 months measured by the Kid_KiddoKINDL-R questionnaire
Time Frame: 12 months after the intervention
|
The Kid_KiddoKINDL-R measures assess physical and emotional well-being of children aged 7 to 17 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 lower symptoms in children
|
12 months after the intervention
|
Collaborators and Investigators
Investigators
- Study Director: Mireia Orgilés Amorós, professor, Miguel Hernadez University of Elche
Publications and helpful links
General Publications
- Orgiles M, Fernandez-Martinez I, Espada JP, Morales A. Spanish version of Super Skills for Life: short- and long-term impact of a transdiagnostic prevention protocol targeting childhood anxiety and depression. Anxiety Stress Coping. 2019 Nov;32(6):694-710. doi: 10.1080/10615806.2019.1645836. Epub 2019 Jul 23.
- Fernandez-Martinez I, Orgiles M, Morales A, Espada JP, Essau CA. One-Year follow-up effects of a cognitive behavior therapy-based transdiagnostic program for emotional problems in young children: A school-based cluster-randomized controlled trial. J Affect Disord. 2020 Feb 1;262:258-266. doi: 10.1016/j.jad.2019.11.002. Epub 2019 Nov 4.
- Melero S, Morales A, Espada JP, Mendez X, Orgiles M. Effectiveness of Group vs. Individual Therapy to Decrease Peer Problems and Increase Prosociality in Children. Int J Environ Res Public Health. 2021 Apr 9;18(8):3950. doi: 10.3390/ijerph18083950.
- Essau CA, Sasagawa S, Jones G, Fernandes B, Ollendick TH. Evaluating the real-world effectiveness of a cognitive behavior therapy-based transdiagnostic program for emotional problems in children in a regular school setting. J Affect Disord. 2019 Jun 15;253:357-365. doi: 10.1016/j.jad.2019.04.036. Epub 2019 Apr 16.
- Yoga Ratnam KK, Nik Farid ND, Yakub NA, Dahlui M. The Effectiveness of the Super Skills for Life (SSL) Programme in Promoting Mental Wellbeing among Institutionalised Adolescents in Malaysia: An Interventional Study. Int J Environ Res Public Health. 2022 Jul 30;19(15):9324. doi: 10.3390/ijerph19159324.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CIACIF/2021/269 (Other Grant/Funding Number: Generalitat Valenciana (España))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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