Social SkillsNCT06444581
Effectiveness of the Universal Prevention Program Super Skills for Life in Schools
A study testing Super Skills Schools in people with Social Skills and Perfectionism, run by Universidad Miguel Hernandez de Elche at 1 site in Spain.
Trial summary
This study aims to evaluate the effectiveness of a 12-session cognitive-behavioral transdiagnostic protocol for Spanish children aged 8 to 12 within an educational context, Super Skills for Life. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Social Skills, Perfectionism, Self Esteem
- What is being tested?
- Super Skills Schools
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,100 participants
- Where
- 1 siteSpain
- Study dates
- 8 Jan 2024to May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 8 to 12 years.
- Be Spanish-speaking.
- Accepting informed consent to participate in the study.
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
Department of Health Psychology. Miguel Hernandez University of Elche
Elche, Alicante, 03203
About this study
Official title: Prevention of Emotional Problems in Spanish School Children Aged 8 to 12 Years Old: Evaluation of the Super Skills for Life Program
This study aims to evaluate the effectiveness of a 12-session cognitive-behavioral transdiagnostic protocol for Spanish children aged 8 to 12 within an educational context, Super Skills for Life. The program, designed to enhance emotional management and social interaction skills, will be delivered in a group format and supplemented with multimedia materials. The study will compare outcomes between an intervention group and a wait-list control group.
Read the detailed description
A 2 x 4 factorial design will be employed, with the intervention condition (intervention or waiting list) as the intergroup factor and the evaluation phase (pretest, posttest, 6-month follow-up, and 12-month follow-up) as the intragroup factor. Both parents and children will complete the same assessments at baseline, post-treatment, and follow-up stages. The researchers will analyze the changes in emotional and social variables from pre- to post-assessment in children who participate in the program.
- Conditions
- Social Skills, Perfectionism, Self Esteem, Positive Affect, Negative Affect, Emotion Regulation
- Being tested
- Super Skills Schools
- Keywords
- Social skills, Emotional skills, Prevention universal program, Program evaluation, Transdiagnostic protocol, Cognitive-behavioral protocol, Childhood, Children, School, Educational context, Group format
- Medical subject headings
- Social Skills, Emotional Regulation, Depression, Anxiety Disorders, Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Super Skills SchoolsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Group experimental | 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. Receives: Behavioral: Super Skills Schools |
| Group without any intervention | No 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Social Skills Questionnaire (SSQ) (Pupil Version)
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.
Measured: Baseline
Social Skills Questionnaire (SSQ) (Pupil Version)
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.
Measured: Immediately after the intervention
Social Skills Questionnaire (SSQ) (Pupil Version)
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.
Measured: 6 months after the intervention
Social Skills Questionnaire (SSQ) (Pupil Version)
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.
Measured: 12 months after the intervention
The Positive and Negative Affect Schedule for Children-Short Form (PANAS-C-SF)
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).
Measured: Baseline
The Positive and Negative Affect Schedule for Children-Short Form (PANAS-C-SF)
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).
Measured: Immediately after the intervention
The Positive and Negative Affect Schedule for Children-Short Form (PANAS-C-SF)
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).
Measured: 6 months after the intervention
The Positive and Negative Affect Schedule for Children-Short Form (PANAS-C-SF)
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).
Measured: 12 months after the intervention
Measured by the Cognitive Emotion Regulation Questionnaire (CERQ-k)
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.
Measured: Baseline
Measured by the Cognitive Emotion Regulation Questionnaire (CERQ-k)
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.
Measured: Immediately after the intervention
Measured by the Cognitive Emotion Regulation Questionnaire (CERQ-k)
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.
Measured: 6 months after the intervention
Measured by the Cognitive Emotion Regulation Questionnaire (CERQ-k)
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.
Measured: 12 months after the intervention
Baseline children's reported anxiety symptoms. Measured by Spence Children's Anxiety Scale Child Report Short (SCAS-C-8)
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.
Measured: Baseline
Baseline children's reported anxiety symptoms. Measured by Spence Children's Anxiety Scale Child Report Short (SCAS-C-8)
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.
Measured: Immediately after the intervention
Baseline children's reported anxiety symptoms. Measured by Spence Children's Anxiety Scale Child Report Short (SCAS-C-8)
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.
Measured: 6 months after the intervention
Baseline children's reported anxiety symptoms. Measured by Spence Children's Anxiety Scale Child Report Short (SCAS-C-8)
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.
Measured: 12 months after the intervention
Measured by Mood and Feelings Questionnaire - Short Version (MFQS)
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.
Measured: Baseline
Measured by Mood and Feelings Questionnaire - Short Version (MFQS)
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.
Measured: Immediately after the intervention
Measured by Mood and Feelings Questionnaire - Short Version (MFQS)
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.
Measured: 6 months after the intervention
Measured by Mood and Feelings Questionnaire - Short Version (MFQS)
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.
Measured: 12 months after the intervention
Baseline level of physical and emotional well-being reported by children as measured by the KidKINDL_children questionnaire.
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.
Measured: Baseline
Level of physical and emotional well-being reported by children as measured by the KidKINDL_children questionnaire.
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.
Measured: Immediately after the intervention
Level of physical and emotional well-being reported by children as measured by the KidKINDL_children questionnaire.
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.
Measured: 6 months after the intervention
Level of physical and emotional well-being reported by children as measured by the KidKINDL_children questionnaire.
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.
Measured: 12 months after the intervention
Self-Concept Form 5 (AF-5)
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.
Measured: Baseline
Self-Concept Form 5 (AF-5)
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.
Measured: Immediately after the intervention
Self-Concept Form 5 (AF-5)
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.
Measured: 6 months after the intervention
Self-Concept Form 5 (AF-5)
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.
Measured: 12 months after the intervention
Secondary outcomes (8)
The Child-Adolescent Perfectionism Scale (CAPS-S)
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.
Measured: Baseline
The Child-Adolescent Perfectionism Scale (CAPS-S)
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.
Measured: Immediately after the intervention
The Child-Adolescent Perfectionism Scale (CAPS-S)
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.
Measured: 6 months after the intervention
The Child-Adolescent Perfectionism Scale (CAPS-S)
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.
Measured: 12 months after the intervention
Baseline level of physical and emotional well-being reported by parents as measured by the Kid_KiddoKINDL-R questionnaire
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
Measured: Baseline
Level of physical and emotional well-being reported by parents immediately after the intervention measured by the Kid_KiddoKINDL-R questionnaire
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
Measured: 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
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
Measured: 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
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
Measured: 12 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2024
- Study start8 Jan 2024
- Primary completion15 May 2024
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Social SkillsStudies 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
- Participants who meet the inclusion criteria and undergo the full baseline assessment will be assigned to the intervention group condition or to the wait-list control (WLC) group. Children assigned to the intervention condition will receive the twelve-week intervention. Participants in the WLC group will not receive any psychological intervention during the twelve-week program. Children and parents in all groups will complete the same set of measures at approximately the same time (pre-test and post-twelve 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
- 1,100 participants (actual)
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, professor, Study director, Miguel Hernadez University of Elche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06444581
- Sponsor's protocol ID
- CIACIF/2021/269
- Other IDs
- CIACIF/2021/269
- Status last verified
- Dec 2024
- First submitted
- 22 May 2024
- Last updated
- 9 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
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.
PubMed 31334667Fernandez-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.
PubMed 31733917Melero 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.
PubMed 33918640Essau 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.
PubMed 31078836Yoga 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.
PubMed 35954681
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Emotional Problems in Spanish School Children Aged 8 to 12 Years Old: Evaluation of the Super Skills for Life Program
- ClinicalTrials.gov ID
- NCT06444581
- Acronym / sponsor ID
- CIACIF/2021/269
- Conditions
- Social Skills, Perfectionism, Self Esteem, Positive Affect, Negative Affect, Emotion Regulation
- Keywords
- Social skills, Emotional skills, Prevention universal program, Program evaluation, Transdiagnostic protocol, Cognitive-behavioral protocol, Childhood, Children
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,100 participants (actual)
- Lead sponsor
- Universidad Miguel Hernandez de ElcheUniversity, hospital or other
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- 15 May 2024 (actual)
- Study completion
- May 2025 (estimated)
- First posted
- 5 Jun 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.
This study aims to evaluate the effectiveness of a 12-session cognitive-behavioral transdiagnostic protocol for Spanish children aged 8 to 12 within an educational context, Super Skills for Life. The program, designed to enhance emotional management and social interaction skills, will be delivered in a group format and supplemented with multimedia materials. The study will compare outcomes between an intervention group and a wait-list control group.
Detailed description
A 2 x 4 factorial design will be employed, with the intervention condition (intervention or waiting list) as the intergroup factor and the evaluation phase (pretest, posttest, 6-month follow-up, and 12-month follow-up) as the intragroup factor. Both parents and children will complete the same assessments at baseline, post-treatment, and follow-up stages. The researchers will analyze the changes in emotional and social variables from pre- to post-assessment in children who participate in the program.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants who meet the inclusion criteria and undergo the full baseline assessment will be assigned to the intervention group condition or to the wait-list control (WLC) group. Children assigned to the intervention condition will receive the twelve-week intervention. Participants in the WLC group will not receive any psychological intervention during the twelve-week program. Children and parents in all groups will complete the same set of measures at approximately the same time (pre-test and post-twelve weeks). Children in the WLC group will receive the intervention after the follow-up visit is completed.
| Arm | Type | Receives |
|---|---|---|
| Group experimental | Experimental | Behavioral: Super Skills SchoolsSuper 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. |
| Group without any intervention | No 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. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children aged 8 to 12 years.
- Be Spanish-speaking.
- Accepting informed consent to participate in the study.
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 |
|---|---|---|
| Super Skills SchoolsSuper 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. | Behavioural | Group experimental |
Primary outcome
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.
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.
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.
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.
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).
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).
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).
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).
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.
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.
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.
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.
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 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
8 secondary outcomes
The Child-Adolescent Perfectionism Scale (CAPS-S)
Time frame: Baseline
The Child-Adolescent Perfectionism Scale (CAPS-S)
Time frame: Immediately after the intervention
The Child-Adolescent Perfectionism Scale (CAPS-S)
Time frame: 6 months after the intervention
The Child-Adolescent Perfectionism Scale (CAPS-S)
Time frame: 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
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
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
. 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Results publication: PubMed 31334667Orgiles 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.
- Results publication: PubMed 31733917Fernandez-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.
- Results publication: PubMed 33918640Melero 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.
- Results publication: PubMed 31078836Essau 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.
- Results publication: PubMed 35954681Yoga 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.
- The Child Research Center is the Miguel Hernández University's center dedicated to child and adolescent mental healthLink provided by the sponsor.
- Super Skills for Life program website in worldLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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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, professor study director
Miguel Hernadez University of 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 Super Skills Schools in people with Social Skills and Perfectionism, 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 3 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: under way, not looking for participants, as of the sponsor's last update on 9 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Social Skills Questionnaire (SSQ) (Pupil Version) (time frame: Baseline). The study lists 28 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 NCT06444581, which also lists 5 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 9 Dec 2024.