Effectiveness of the Universal Prevention Program Super Skills for Life in Schools

Depressive Symptoms Clinical Trial

Official title:

Prevention of Emotional Problems in Spanish School Children Aged 8 to 12 Years Old: Evaluation of the Super Skills for Life Program

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06444581
• Other study ID #: CIACIF/2021/269
• Secondary ID: CIACIF/2021/269
• Status: Recruiting
• Phase: N/A
• Start date: January 8, 2024
• Est. completion date: May 2025

Study information

• Verified date: June 2024
• Source: Universidad Miguel Hernandez de Elche
• Contact: Damián Hervás Begines, researcher
• Phone: +34965222071
• Email: dhervas[@]umh.es
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: May 2025
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Symptoms
• Depression
• Depressive Symptoms
• Emotion Regulation
• Emotional Intelligence
• Mood Disorders
• Perfectionism
• Positive Affect
• Self Esteem
• Social Skills

Intervention

Behavioral:
• Super Skills Schools
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.

Locations

Country	Name	City	State
Spain	Department of Health Psychology. Miguel Hernandez University of Elche	Elche	Alicante

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Miguel Hernandez de Elche

Country where clinical trial is conducted

Spain, 

References & Publications (5)

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;25 — View Citation

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 Affec — View Citation

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. — View Citation

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 — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline
Primary	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.	Immediately after the intervention
Primary	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.	6 months after the intervention
Primary	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.	12 months after the intervention
Primary	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).	Baseline
Primary	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).	Immediately after the intervention
Primary	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).	6 months after the intervention
Primary	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).	12 months after the intervention
Primary	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.	Baseline
Primary	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.	Immediately after the intervention
Primary	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.	6 months after the intervention
Primary	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.	12 months after the intervention
Primary	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.	Baseline
Primary	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.	Immediately after the intervention
Primary	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.	6 months after the intervention
Primary	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.	12 months after the intervention
Primary	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.	Baseline
Primary	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.	Immediately after the intervention
Primary	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.	6 months after the intervention
Primary	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.	12 months after the intervention
Primary	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.	Baseline
Primary	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.	Immediately after the intervention
Primary	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.	6 months after the intervention
Primary	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.	12 months after the intervention
Primary	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.	Baseline
Primary	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.	Immediately after the intervention
Primary	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.	6 months after the intervention
Primary	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.	12 months after the intervention
Secondary	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.	Baseline
Secondary	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.	Immediately after the intervention
Secondary	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.	6 months after the intervention
Secondary	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.	12 months after the intervention
Secondary	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	Baseline
Secondary	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	Immediately after the intervention
Secondary	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	6 months after the intervention
Secondary	. 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	12 months after the intervention

External Links

•   Super Skills for Life program website in Spain
•   Super Skills for Life program website in world
•   The Child Research Center is the Miguel Hernández University's center dedicated to child and adolescent mental health