Super Skills for Life Effectiveness in Clinical Settings

Study Overview
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Brief Summary
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Super Skills for Life (SSL) is a transdiagnostic cognitive-behavioral protocol developed for children aged 6 to 12 with anxiety and comorbid problems (e.g., depression, low self-esteem, and lack of social skills). SSL consists of eight sessions targeting common risk factors for internalizing disorders such as cognitive distortions, avoidance, emotional management, low self-esteem, social skills deficits and coping strategies. The aim of the study is to investigate the short- and long-term effects of SSL on internalizing and externalizing symptoms in Spanish children attending the Child and Adolescent Mental Health Services.

Detailed Description
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To validate eligibility children and their parents will complete several psychometrically robust and developmentally appropriate measures. Participants meeting inclusion criteria will be randomly allocated to the conditions of the intervention group and the wait-list control group. Parents and children from both groups will complete the same measures at baseline and post-treatment. Parents and children from SSL will also complete these measures at 3 months follow-up, 6 months follow-up and 12 months follow-up. The investigators will assess the benefits from pre-test to post-test in children participating in SSL compared to those in a wait-list control group on DSM-5 diagnostic remission, anxiety symptoms, anxiety impairment, depressive symptoms, self-esteem, behavioral problems, hyperactivity/inattention, peer relationship problems, and prosocial behavior. The investigators will also assess these variables in the intervention group at 3 months, 6 months, and 12 months follow-up. Ultimately, the goal of the study is to explore whether SSL can be a cost-effective psychological intervention for emotional disorders in the Spanish National Health System.

Official Title
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Treatment of Emotional Disorders in Spanish Children: Efficacy of Super Skills for Life Transdiagnostic Treatment

Conditions
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Depressive Disorder, Depressive Symptoms, Trauma and Stressor Related Disorders, Anxiety Disorders and Symptoms, Anxiety Disorders, Mood Disorders, Emotional Disorder

Intervention / Treatment
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* Behavioral: Super Skills for Life


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children aged 8 - 12. Primary diagnosis of an anxiety disorder, a depressive disorder, and/or trauma- or stress-related disorder with anxiety and/or depressive symptoms. Speaking, reading, writing and understanding Spanish. Caregivers agree to attend all sessions and to receive feedback and suggestions. Exclusion Criteria: Intellectual disability, behavioral symptoms, or autism spectrum symptoms whose severity precluded continued treatment. The child is at the same time in psychological treatment. The child is not on a stable dose of medication for at least 1 month prior to baseline assessment.

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Participants who met the inclusion criteria and underwent thorough the baseline assessment were randomly allocated to the conditions of the intervention group and the wait-list control group. Participants in the wait-list group (WLC) received no phycological (public or private) intervention during the eight-week duration of the program. Children and parents in both groups would complete the same series of measures at about the same time (pre-test and after eight weeks). Children in WLC group will receive the intervention once the follow-up visit is completed.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Super Skills for Life intervention group | Behavioral: Super Skills for Life<br>* Structured and manualized intervention with a manual for the therapist and a workbook for the children. Spanish version of Super Skills for Life group program: Orgilés, M., Espada, J.P., Ollendick, T.H. & Essau, C. (2022). Programa Super Skills. Manual del aplicador. Elche, ES: Universidad Miguel Hernández. The intervention was administered by a trained clinical psychologist in SSL. Sessions were held after school hours once a week for eight weeks, with each session lasting approximately one hour. The contents of the program were covered through playful activities in groups of 4 to 6 children<br>|
| No Intervention: Wait-list group<br>Group without any intervention. Participants in the wait-list group received no phycological (public or private) intervention during the eight-week duration of the SSL program. They were informed that children in this group will receive the intervention once the follow-up visit is completed. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline diagnosis based on DSM-5 criteria to immediately after the intervention | Measured by Schedule for affective disorders and schizophrenia for schoolage youths-present and lifetime version (K-SADS-PL). The K-SADS-PL is a semi-structured interview for children and adolescents aged 6 to 18 years according to DSM-IV criteria. Additional questions were included in this study to obtain a diagnosis according to the current DSM-5 classification. | baseline and immediately after the intervention | 
| Diagnosis based on DSM-5 criteria at 3 months | Measured by Schedule for affective disorders and schizophrenia for schoolage youths-present and lifetime version (K-SADS-PL). The K-SADS-PL is a semi-structured interview for children and adolescents aged 6 to 18 years according to DSM-IV criteria. Additional questions were included in this study to obtain a diagnosis according to the current DSM-5 classification. | 3 months after the intervention | 
| Diagnosis based on DSM-5 criteria at 6 months | Measured by Schedule for affective disorders and schizophrenia for schoolage youths-present and lifetime version (K-SADS-PL). The K-SADS-PL is a semi-structured interview for children and adolescents aged 6 to 18 years according to DSM-IV criteria. Additional questions were included in this study to obtain a diagnosis according to the current DSM-5 classification. | 6 months after the intervention | 
| Diagnosis based on DSM-5 criteria at 1 year | Measured by Schedule for affective disorders and schizophrenia for schoolage youths-present and lifetime version (K-SADS-PL). The K-SADS-PL is a semi-structured interview for children and adolescents aged 6 to 18 years according to DSM-IV criteria. Additional questions were included in this study to obtain a diagnosis according to the current DSM-5 classification. | 1 year after the intervention | 
| Change from baseline depression symptoms to immediately after the intervention | Measured by Child Depression Inventory (CDI). It assess depressive symptoms experienced in the past two weeks. The CDI provides an overall score (minimum value 0, maximum value 54) and two dimensions values: dysphoria (minimum value 0, maximum value 34), and negative self-esteem (minimum value 0, maximum value 20). Higher scores indicate more severe symptoms. | baseline and immediately after the intervention | 
| Depression symptoms at 3 months | Measured by Child Depression Inventory (CDI). It assess depressive symptoms experienced in the past two weeks. The CDI provides an overall score (minimum value 0, maximum value 54) and two dimensions values: dysphoria (minimum value 0, maximum value 34), and negative self-esteem (minimum value 0, maximum value 20). Higher scores indicate more severe symptoms. | 3 months after the intervention | 
| Depression symptoms at 6 months | Measured by Child Depression Inventory (CDI). It assess depressive symptoms experienced in the past two weeks. The CDI provides an overall score (minimum value 0, maximum value 54) and two dimensions values: dysphoria (minimum value 0, maximum value 34), and negative self-esteem (minimum value 0, maximum value 20). Higher scores indicate more severe symptoms. | 6 months after the intervention | 
| Depression symptoms at 1 year | Measured by Child Depression Inventory (CDI). It assess depressive symptoms experienced in the past two weeks. The CDI provides an overall score (minimum value 0, maximum value 54) and two dimensions values: dysphoria (minimum value 0, maximum value 34), and negative self-esteem (minimum value 0, maximum value 20). Higher scores indicate more severe symptoms. | 1 year after the intervention | 
| Change from baseline parent-reported anxiety symptoms to immediately after the intervention | Measured by Spence Children's Anxiety Scale Parent Report (SCAS-P). SCAS-P measures symptoms severity of the DSM-IV anxiety disorders in children (subscales: total, panic and agoraphobia, generalized anxiety disorder, obsessive-compulsive disorder, social phobia, separation anxiety and specific fears). 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 114. Higher scores indicating greater severity of symptoms. | baseline and immediately after the intervention | 
| Change from baseline children's reported anxiety symptoms to immediately after the intervention | Measured by Spence Children's Anxiety Scale Child Report (SCAS). SCAS measures symptoms severity of the DSM-IV anxiety disorders in children (subscales: total, panic and agoraphobia, generalized anxiety disorder, obsessive-compulsive disorder, social phobia, separation anxiety and specific fears). 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 114. Higher scores indicating greater severity of symptoms. | baseline and immediately after the intervention | 
| Parent-reported anxiety symptoms at 3 months | Measured by Spence Children's Anxiety Scale Parent Report (SCAS-P). SCAS-P measures symptoms severity of the DSM-IV anxiety disorders in children (subscales: total, panic and agoraphobia, generalized anxiety disorder, obsessive-compulsive disorder, social phobia, separation anxiety and specific fears). 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 114. Higher scores indicating greater severity of symptoms. | 3 months after the intervention | 
| Children's reported anxiety symptoms at 3 months | Measured by Spence Children's Anxiety Scale Child Report (SCAS). SCAS measures symptoms severity of the DSM-IV anxiety disorders in children (subscales: total, panic and agoraphobia, generalized anxiety disorder, obsessive-compulsive disorder, social phobia, separation anxiety and specific fears). 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 114. Higher scores indicating greater severity of symptoms. | 3 months after the intervention | 
| Parent-reported anxiety symptoms at 6 months | Measured by Spence Children's Anxiety Scale Parent Report (SCAS-P). SCAS-P measures symptoms severity of the DSM-IV anxiety disorders in children (subscales: total, panic and agoraphobia, generalized anxiety disorder, obsessive-compulsive disorder, social phobia, separation anxiety and specific fears). 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 114. Higher scores indicating greater severity of symptoms. | 6 months after the intervention | 
| Children's reported anxiety symptoms at 6 months | Measured by Spence Children's Anxiety Scale Child Report (SCAS). SCAS measures symptoms severity of the DSM-IV anxiety disorders in children (subscales: total, panic and agoraphobia, generalized anxiety disorder, obsessive-compulsive disorder, social phobia, separation anxiety and specific fears). 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 114. Higher scores indicating greater severity of symptoms. | 6 months after the intervention | 
| Parent-reported anxiety symptoms at 1 year | Measured by Spence Children's Anxiety Scale Parent Report (SCAS-P). SCAS-P measures symptoms severity of the DSM-IV anxiety disorders in children (subscales: total, panic and agoraphobia, generalized anxiety disorder, obsessive-compulsive disorder, social phobia, separation anxiety and specific fears). 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 114. Higher scores indicating greater severity of symptoms. | 1 year after the intervention | 
| Children's reported anxiety symptoms at 1 year | Measured by Spence Children's Anxiety Scale Child Report (SCAS). SCAS measures symptoms severity of the DSM-IV anxiety disorders in children (subscales: total, panic and agoraphobia, generalized anxiety disorder, obsessive-compulsive disorder, social phobia, separation anxiety and specific fears). 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 114. Higher scores indicating greater severity of symptoms. | 1 year after the intervention | 
| Change from baseline parent-reported anxiety-related interference to immediately after the intervention | Measured by Child Anxiety Life Interference Scale Parent Report (CALIS-P). It assesses life interference and impairment related to anxiety in the child's school, social, and home/family settings. Scores range from a minimum value of 0 to a maximun value of 64. Higher scores indicate larger child anxiety-related interference. | baseline and immediately after the intervention | 
| Change from baseline children's reported anxiety-related interference to immediately after the intervention | Measured by Child Anxiety Life Interference Scale Child Report (CALIS-C). It assesses life interference and impairment related to anxiety in the child's school, social, and home/family settings. Scores range from a minimum value of 0 to a maximun value of 36. Higher scores indicate larger child anxiety-related interference. | baseline and immediately after the intervention | 
| Parent-reported anxiety-related interference at 3 months | Measured by Child Anxiety Life Interference Scale Parent Report (CALIS-P). It assesses life interference and impairment related to anxiety in the child's school, social, and home/family settings. Scores range from a minimum value of 0 to a maximun value of 64. Higher scores indicate larger child anxiety-related interference. | 3 months after the intervention | 
| Children's reported anxiety-related interference at 3 months | Measured by Child Anxiety Life Interference Scale Child Report (CALIS-C). It assesses life interference and impairment related to anxiety in the child's school, social, and home/family settings. Scores range from a minimum value of 0 to a maximun value of 36. Higher scores indicate larger child anxiety-related interference. | 3 months after the intervention | 
| Parent-reported anxiety-related interference at 6 months | Measured by Child Anxiety Life Interference Scale Parent Report (CALIS-P). It assesses life interference and impairment related to anxiety in the child's school, social, and home/family settings. Scores range from a minimum value of 0 to a maximun value of 64. Higher scores indicate larger child anxiety-related interference. | 6 months after the intervention | 
| Children's reported anxiety-related interference at 6 months | Measured by Child Anxiety Life Interference Scale Child Report (CALIS-C). It assesses life interference and impairment related to anxiety in the child's school, social, and home/family settings. Scores range from a minimum value of 0 to a maximun value of 36. Higher scores indicate larger child anxiety-related interference. | 6 months after the intervention | 
| Parent-reported anxiety-related interference at 1 year | Measured by Child Anxiety Life Interference Scale Parent Report (CALIS-P). It assesses life interference and impairment related to anxiety in the child's school, social, and home/family settings. Scores range from a minimum value of 0 to a maximun value of 64. Higher scores indicate larger child anxiety-related interference. | 1 year after the intervention | 
| Children's reported anxiety-related interference at 1 year | Measured by Child Anxiety Life Interference Scale Child Report (CALIS-C). It assesses life interference and impairment related to anxiety in the child's school, social, and home/family settings. Scores range from a minimum value of 0 to a maximun value of 36. Higher scores indicate larger child anxiety-related interference. | 1 year after the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline children's reported global mental health symptoms to immediately after the intervention | Measured by Strengths and Difficulties Questionnaire Child Report (SDQ). It was designed to measure children's overall difficulties (minimum value 0 and maximum value 40) and positive attributes across five subscales (minimum value 0 and maximun value 10): Emotional symptoms (e.g., anxiety and depression), Conduct problems, Hyperactivity/Inattention, Peer relationships (difficulties), and Pro-social behavior. . Higher scores indicate higher levels of difficulties, except on the prosocial subscale, where higher scores reflect a more positive attribute. | baseline and immediately after the intervention | 
| Change from baseline parent's reported global mental health symptoms to immediately after the intervention | Measured by Strengths and Difficulties Questionnaire Parent Report (SDQ-P). It was designed to measure children's overall difficulties (minimum value 0 and maximum value 40) and positive attributes across five subscales (minimum value 0 and maximum value 10): Emotional symptoms (e.g., anxiety and depression), Conduct problems, Hyperactivity/Inattention, Peer relationships (difficulties), and Pro-social behavior. . Higher scores indicate higher levels of difficulties, except on the prosocial subscale, where higher scores reflect a more positive attribute. | baseline and immediately after the intervention | 
| Children's reported global mental health symptoms at 3 months | Measured by Strengths and Difficulties Questionnaire Child Report (SDQ). It was designed to measure children's overall difficulties (minimum value 0 and maximum value 40) and positive attributes across five subscales (minimum value 0 and maximun value 10): Emotional symptoms (e.g., anxiety and depression), Conduct problems, Hyperactivity/Inattention, Peer relationships (difficulties), and Pro-social behavior. . Higher scores indicate higher levels of difficulties, except on the prosocial subscale, where higher scores reflect a more positive attribute. | 3 months after the intervention | 
| Parent's reported global mental health symptoms at 3 months | Measured by Strengths and Difficulties Questionnaire Parent Report (SDQ-P). It was designed to measure children's overall difficulties (minimum value 0 and maximum value 40) and positive attributes across five subscales (minimum value 0 and maximum value 10): Emotional symptoms (e.g., anxiety and depression), Conduct problems, Hyperactivity/Inattention, Peer relationships (difficulties), and Pro-social behavior. . Higher scores indicate higher levels of difficulties, except on the prosocial subscale, where higher scores reflect a more positive attribute. | 3 months after the intervention | 
| Children's reported global mental health symptoms at 6 months | Measured by Strengths and Difficulties Questionnaire Child Report (SDQ). It was designed to measure children's overall difficulties (minimum value 0 and maximum value 40) and positive attributes across five subscales (minimum value 0 and maximun value 10): Emotional symptoms (e.g., anxiety and depression), Conduct problems, Hyperactivity/Inattention, Peer relationships (difficulties), and Pro-social behavior. . Higher scores indicate higher levels of difficulties, except on the prosocial subscale, where higher scores reflect a more positive attribute. | 6 months after the intervention | 
| Parent's reported global mental health symptoms at 6 months | Measured by Strengths and Difficulties Questionnaire Parent Report (SDQ-P). It was designed to measure children's overall difficulties (minimum value 0 and maximum value 40) and positive attributes across five subscales (minimum value 0 and maximum value 10): Emotional symptoms (e.g., anxiety and depression), Conduct problems, Hyperactivity/Inattention, Peer relationships (difficulties), and Pro-social behavior. . Higher scores indicate higher levels of difficulties, except on the prosocial subscale, where higher scores reflect a more positive attribute. | 6 months after the intervention | 
| Children's reported global mental health symptoms at 1 year | Measured by Strengths and Difficulties Questionnaire Child Report (SDQ). It was designed to measure children's overall difficulties (minimum value 0 and maximum value 40) and positive attributes across five subscales (minimum value 0 and maximun value 10): Emotional symptoms (e.g., anxiety and depression), Conduct problems, Hyperactivity/Inattention, Peer relationships (difficulties), and Pro-social behavior. . Higher scores indicate higher levels of difficulties, except on the prosocial subscale, where higher scores reflect a more positive attribute. | 1 year after the intervention | 
| Parent's reported global mental health symptoms at 1 year | Measured by Strengths and Difficulties Questionnaire Parent Report (SDQ-P). It was designed to measure children's overall difficulties (minimum value 0 and maximum value 40) and positive attributes across five subscales (minimum value 0 and maximum value 10): Emotional symptoms (e.g., anxiety and depression), Conduct problems, Hyperactivity/Inattention, Peer relationships (difficulties), and Pro-social behavior. . Higher scores indicate higher levels of difficulties, except on the prosocial subscale, where higher scores reflect a more positive attribute. | 1 year after the intervention | 
| Change from baseline self-esteem to 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. | baseline and immediately after the intervention | 
| Self-esteem at 3 months | 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. | 3 months after the intervention | 
| Self-esteem at 6 months | 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 | 
| Self-esteem at 1 year | 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. | 1 year after the intervention | 
| Perfectionism | Frost Multidimensional Perfectionism Scale (FMPS). A self-report measure with four sub-scales of perfectionism: concern over mistakes and doubts about actions, excessive concern with parents' expectations and evaluation, excessively high personal standards, concern with precision, order and organisation. | pre-intervention | 
| Changes from baseline health-related quality of life to immediately after the intervention | Health-Related Quality of Life Questionnaire for Children and Adolescents aged from 8 to 18 years (KIDSCREEN). It assess children's and parents' subjective health and well-being in 10 areas. | baseline and immediately after the intervention | 
| Health-related quality of life at 3 months | Health-Related Quality of Life Questionnaire for Children and Adolescents aged from 8 to 18 years (KIDSCREEN). It assess children's and parents' subjective health and well-being in 10 areas. | 3 months after the intervention | 
| Health-related quality of life at 6 months | Health-Related Quality of Life Questionnaire for Children and Adolescents aged from 8 to 18 years (KIDSCREEN). It assess children's and parents' subjective health and well-being in 10 areas. | 6 months after the intervention | 
| Health-related quality of life at 1 year | Health-Related Quality of Life Questionnaire for Children and Adolescents aged from 8 to 18 years (KIDSCREEN). It assess children's and parents' subjective health and well-being in 10 areas. | 1 year after the intervention |