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Effectiveness of Individual and Multimedia Versions of Super Skills for Life in Children

Primary Purpose

Depressive Disorder, Depressive Symptoms, Anxiety Disorders

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Super Skills for Life
Sponsored by
Universidad Miguel Hernandez de Elche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Disorder

Eligibility Criteria

8 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Children aged 8 - 12 years old.
  • Presence of emotional symptoms. This will be assessed by means of a screening test to be completed by parents (Spanish version of the Strenghts and Difficulties Questionnaire [SDQ]). The cut-off point for children to be included in the study will be that they present a score above 4 on the Emotional Problems subscale of the SDQ questionnaire.
  • Speaking, reading, writing and understanding Spanish.

Exclusion Criteria:

  • Intellectual disability, behavioral symptoms, or autism spectrum symptoms whose severity precluded continued treatment.
  • Being receiving current psychological or pharmacological treatment for anxiety and/or depression.
  • Not accepting or revoking informed consent to participate in the study.

Sites / Locations

  • Department of Health Psychology. Miguel Hernandez University of ElcheRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Super Skills for Life intervention group: traditional version

Super Skills for Life intervention group: multimedia version

No Intervention: Wait-list group

Arm Description

The Super Skills for Life program will be administered following the manual of the intervention by a trained therapist, as described in the section of intervention/treatment.

The Super Skills for Life program will be administered in-person as well by a trained therapist, as described in the section of intervention treatment. The therapist will use the multimedia presentation of the program's contents as a tool for the better development of the sessions. The digital version of the program consists of an animation whose characters narrate examples that help the children better understand the contents. The therapist will have a password assigned to each child, and it will be the therapist who will guide the sessions and select the contents of the digital presentation that correspond to each session. The web address to access the programme is https://www.superskillsonline.com/.

Group without any intervention. Participants in the wait-list group will receive no psychological intervention during the eight-week duration of the SSL program. Families will be informed that children in this group will receive the intervention once the follow-up visit is completed.

Outcomes

Primary Outcome Measures

Baseline children's reported anxiety symptoms
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.
Children's reported anxiety symptoms 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.
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.
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.
Children's reported anxiety symptoms at 12 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.
Baseline parent-reported anxiety symptoms
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.
Parent-reported anxiety symptoms 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.
Parent-reported anxiety symptoms immediately 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.
Parent-reported anxiety symptoms immediately 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.
Parent-reported anxiety symptoms immediately at 12 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.
Baseline children's reported depressive symptoms
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.
Children's reported depressive symptoms 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.
Children's reported depressive symptoms at 3 months
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.
Children's reported depressive symptoms at 6 months
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.
Children's reported depressive symptoms at 12 months
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 parent-reported depressive symptoms
Measured by Mood and Feelings Questionnaire Parent-Report - Short Version (MFQS-P). 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.
Parent-reported depressive symptoms immediately after the intervention
Measured by Mood and Feelings Questionnaire Parent-Report - Short Version (MFQS-P). 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.
Parent-reported depressive symptoms immediately at 3 months
Measured by Mood and Feelings Questionnaire Parent-Report - Short Version (MFQS-P). 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.
Parent-reported depressive symptoms immediately at 6 months
Measured by Mood and Feelings Questionnaire Parent-Report - Short Version (MFQS-P). 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.
Parent-reported depressive symptoms immediately at 12 months
Measured by Mood and Feelings Questionnaire Parent-Report - Short Version (MFQS-P). 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.

Secondary Outcome Measures

Baseline children's anxiety-related interference
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.
Children's anxiety-related interference 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.
Children's 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.
Children's 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.
Children's anxiety-related interference at 12 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.
Baseline parent-reported anxiety-related interference
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.
Parent-reported anxiety-related interference 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.
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.
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.
Parent-reported anxiety-related interference at 12 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.
Baseline self-esteem
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.
Self-esteem 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.
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.
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.
Self-esteem at 12 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.
Baseline social skills
Social Skills Questionnaire (SSQ). It measures children's social functioning, as reflected by specific behavioural responses during interaction with another person. The scale consists of 30 items rated 0 to 2 points. Minimum value 0 and maximum value 60. Higher scores indicate higher social skills.
Social skills immediately after the intervention
Social Skills Questionnaire (SSQ). It measures children's social functioning, as reflected by specific behavioural responses during interaction with another person. The scale consists of 30 items rated 0 to 2 points. Minimum value 0 and maximum value 60. Higher scores indicate higher social skills.
Social skills at 3 months
Social Skills Questionnaire (SSQ). It measures children's social functioning, as reflected by specific behavioural responses during interaction with another person. The scale consists of 30 items rated 0 to 2 points. Minimum value 0 and maximum value 60. Higher scores indicate higher social skills.
Social skills at 6 months
Social Skills Questionnaire (SSQ). It measures children's social functioning, as reflected by specific behavioural responses during interaction with another person. The scale consists of 30 items rated 0 to 2 points. Minimum value 0 and maximum value 60. Higher scores indicate higher social skills.
Social skills at 12 months
Social Skills Questionnaire (SSQ). It measures children's social functioning, as reflected by specific behavioural responses during interaction with another person. The scale consists of 30 items rated 0 to 2 points. Minimum value 0 and maximum value 60. Higher scores indicate higher social skills.
Baseline social worries
Social Worries Questionnaire (SSW). It measures children's social worries, in terms of anxiety about and avoidance of specific social situations in which social evaluation or scrutiny by others is likely to occur. The scale consists of 12 items rated 0 to 2 points. Minimum value 0 and maximum value 24. Higher scores indicate higher social worries.
Social worries immediately after the intervention
Social Worries Questionnaire (SSW). It measures children's social worries, in terms of anxiety about and avoidance of specific social situations in which social evaluation or scrutiny by others is likely to occur. The scale consists of 12 items rated 0 to 2 points. Minimum value 0 and maximum value 24. Higher scores indicate higher social worries.
Social worries at 3 months
Social Worries Questionnaire (SSW). It measures children's social worries, in terms of anxiety about and avoidance of specific social situations in which social evaluation or scrutiny by others is likely to occur. The scale consists of 12 items rated 0 to 2 points. Minimum value 0 and maximum value 24. Higher scores indicate higher social worries.
Social worries at 6 months
Social Worries Questionnaire (SSW). It measures children's social worries, in terms of anxiety about and avoidance of specific social situations in which social evaluation or scrutiny by others is likely to occur. The scale consists of 12 items rated 0 to 2 points. Minimum value 0 and maximum value 24. Higher scores indicate higher social worries.
Social worries at 12 months
Social Worries Questionnaire (SSW). It measures children's social worries, in terms of anxiety about and avoidance of specific social situations in which social evaluation or scrutiny by others is likely to occur. The scale consists of 12 items rated 0 to 2 points. Minimum value 0 and maximum value 24. Higher scores indicate higher social worries.
Baseline cognitive emotion regulation strategies
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.
Cognitive emotion regulation strategies immediately after the intervention
Measured by the Cognitive Emotion Regulation Questionnaire children self-report (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.
Cognitive emotion regulation strategies at 3 months
Measured by the Cognitive Emotion Regulation Questionnaire children self-report (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.
Cognitive emotion regulation strategies at 6 months
Measured by the Cognitive Emotion Regulation Questionnaire children self-report (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.
Cognitive emotion regulation strategies at 12 months
Measured by the Cognitive Emotion Regulation Questionnaire children self-report (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 parental depression, anxiety and stress symptoms
Measured by the Depression Anxiety Stress Scales - short version (DASS-21). It contains a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress. Each of the three DASS-21 scales contains 7 items, divided into subscales with similar content. The depression scale assesses dysphoria, hopelessness, devaluation of life, self-deprecation, lack of interest / involvement, anhedonia and inertia. The anxiety scale assesses autonomic arousal, skeletal muscle effects, situational anxiety, and subjective experience of anxious affect. The stress scale is sensitive to levels of chronic nonspecific arousal. It assesses difficulty relaxing, nervous arousal, and being easily upset / agitated, irritable / over-reactive and impatient. Scores for depression, anxiety and stress are calculated by summing the scores for the relevant items.

Full Information

First Posted
October 6, 2022
Last Updated
May 8, 2023
Sponsor
Universidad Miguel Hernandez de Elche
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1. Study Identification

Unique Protocol Identification Number
NCT05574491
Brief Title
Effectiveness of Individual and Multimedia Versions of Super Skills for Life in Children
Official Title
Comparative Effectiveness of Individual and Multimedia Versions of the Transdiagnostic Program Super Skills for Life in Children Aged 8-12 Years: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 7, 2023 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Miguel Hernandez de Elche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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 comparative effectiveness of SSL in its traditional and multimedia version on internalizing and externalizing symptoms in Spanish children between 8 and 12 years of age.
Detailed Description
Children will be selected to receive the SSL program based on results on psychometrically robust measurements and inclusion/exclusion criteria. Selected children will be randomly assigned to the conditions of the two intervention groups (traditional and multimedia versions of SSL) and the wait-list control (WLC) group. Parents and children from the three groups will complete the same measures at baseline and post-treatment. They will also complete these measures at 3 months follow-up, 6 months follow-up, and 12 months follow-up. Researchers will compare the results of pre-test to post-test assessments in children participating in the traditional and multimedia versions of SSL compared to those in a WLC group on anxiety symptoms, 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Depressive Symptoms, Anxiety Disorders, Anxiety Disorders and Symptoms, Mood Disorders, Emotional Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Participants who met the inclusion criteria and underwent thorough the baseline assessment will be randomly assigned to the conditions of the intervention groups (traditional and multimedia versions of SSL) and the WLC group. Children allocated to the traditional and multimedia versions of the SSL program will receive the eight-week intervention. Participants in WLC group will receive no psychological intervention during the eight-week duration of the program. Children and parents in the three groups will 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
Outcomes Assessor
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Super Skills for Life intervention group: traditional version
Arm Type
Experimental
Arm Description
The Super Skills for Life program will be administered following the manual of the intervention by a trained therapist, as described in the section of intervention/treatment.
Arm Title
Super Skills for Life intervention group: multimedia version
Arm Type
Experimental
Arm Description
The Super Skills for Life program will be administered in-person as well by a trained therapist, as described in the section of intervention treatment. The therapist will use the multimedia presentation of the program's contents as a tool for the better development of the sessions. The digital version of the program consists of an animation whose characters narrate examples that help the children better understand the contents. The therapist will have a password assigned to each child, and it will be the therapist who will guide the sessions and select the contents of the digital presentation that correspond to each session. The web address to access the programme is https://www.superskillsonline.com/.
Arm Title
No Intervention: Wait-list group
Arm Type
No Intervention
Arm Description
Group without any intervention. Participants in the wait-list group will receive no psychological intervention during the eight-week duration of the SSL program. Families will be informed that children in this group will receive the intervention once the follow-up visit is completed.
Intervention Type
Behavioral
Intervention Name(s)
Super Skills for Life
Intervention Description
Structured and manualized intervention with a manual for the therapist and a workbook for the children. The intervention will be administered by trained clinical psychologists in SSL. Sessions will be held once a week for eight weeks, with each session lasting approximately forty five minutes. The program includes emotional education, social skills training, cognitive restructuring, relaxation techniques, self-observation, problem solving and behavioural activation. These contents are learned through playful exercises, activities, readings, and role-playing. Both modalities of intervention will be in-person. 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.
Primary Outcome Measure Information:
Title
Baseline children's reported anxiety symptoms
Description
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.
Time Frame
Baseline
Title
Children's reported anxiety symptoms immediately after the intervention
Description
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.
Time Frame
Immediately after the intervention
Title
Children's reported anxiety symptoms at 3 months
Description
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.
Time Frame
3 months after the intervention
Title
Children's reported anxiety symptoms at 6 months
Description
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.
Time Frame
6 months after the intervention
Title
Children's reported anxiety symptoms at 12 months
Description
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.
Time Frame
12 months after the intervention
Title
Baseline parent-reported anxiety symptoms
Description
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.
Time Frame
Baseline
Title
Parent-reported anxiety symptoms immediately after the intervention
Description
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.
Time Frame
Immediately after the intervention
Title
Parent-reported anxiety symptoms immediately at 3 months
Description
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.
Time Frame
3 months after the intervention
Title
Parent-reported anxiety symptoms immediately at 6 months
Description
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.
Time Frame
6 months after the intervention
Title
Parent-reported anxiety symptoms immediately at 12 months
Description
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.
Time Frame
12 months after the intervention
Title
Baseline children's reported depressive symptoms
Description
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.
Time Frame
Baseline
Title
Children's reported depressive symptoms immediately after the intervention
Description
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.
Time Frame
Immediately after the intervention
Title
Children's reported depressive symptoms at 3 months
Description
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.
Time Frame
3 months after the intervention
Title
Children's reported depressive symptoms at 6 months
Description
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.
Time Frame
6 months after the intervention
Title
Children's reported depressive symptoms at 12 months
Description
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.
Time Frame
12 months after the intervention
Title
Baseline parent-reported depressive symptoms
Description
Measured by Mood and Feelings Questionnaire Parent-Report - Short Version (MFQS-P). 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.
Time Frame
Baseline
Title
Parent-reported depressive symptoms immediately after the intervention
Description
Measured by Mood and Feelings Questionnaire Parent-Report - Short Version (MFQS-P). 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.
Time Frame
Immediately after the intervention
Title
Parent-reported depressive symptoms immediately at 3 months
Description
Measured by Mood and Feelings Questionnaire Parent-Report - Short Version (MFQS-P). 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.
Time Frame
3 months after the intervention
Title
Parent-reported depressive symptoms immediately at 6 months
Description
Measured by Mood and Feelings Questionnaire Parent-Report - Short Version (MFQS-P). 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.
Time Frame
6 months after the intervention
Title
Parent-reported depressive symptoms immediately at 12 months
Description
Measured by Mood and Feelings Questionnaire Parent-Report - Short Version (MFQS-P). 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.
Time Frame
12 months after the intervention
Secondary Outcome Measure Information:
Title
Baseline children's anxiety-related interference
Description
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.
Time Frame
Baseline
Title
Children's anxiety-related interference immediately after the intervention
Description
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.
Time Frame
Immediately after the intervention
Title
Children's anxiety-related interference at 3 months
Description
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.
Time Frame
3 months after the intervention
Title
Children's anxiety-related interference at 6 months
Description
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.
Time Frame
6 months after the intervention
Title
Children's anxiety-related interference at 12 months
Description
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.
Time Frame
12 months after the intervention
Title
Baseline parent-reported anxiety-related interference
Description
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.
Time Frame
Baseline
Title
Parent-reported anxiety-related interference immediately after the intervention
Description
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.
Time Frame
Immediately after the intervention
Title
Parent-reported anxiety-related interference at 3 months
Description
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.
Time Frame
3 months after the intervention
Title
Parent-reported anxiety-related interference at 6 months
Description
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.
Time Frame
6 months after the intervention
Title
Parent-reported anxiety-related interference at 12 months
Description
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.
Time Frame
12 months after the intervention
Title
Baseline self-esteem
Description
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.
Time Frame
Baseline
Title
Self-esteem immediately after the intervention
Description
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.
Time Frame
Immediately after the intervention
Title
Self-esteem at 3 months
Description
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.
Time Frame
3 months after the intervention
Title
Self-esteem at 6 months
Description
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.
Time Frame
6 months after the intervention
Title
Self-esteem at 12 months
Description
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.
Time Frame
12 months after the intervention
Title
Baseline social skills
Description
Social Skills Questionnaire (SSQ). It measures children's social functioning, as reflected by specific behavioural responses during interaction with another person. The scale consists of 30 items rated 0 to 2 points. Minimum value 0 and maximum value 60. Higher scores indicate higher social skills.
Time Frame
Baseline
Title
Social skills immediately after the intervention
Description
Social Skills Questionnaire (SSQ). It measures children's social functioning, as reflected by specific behavioural responses during interaction with another person. The scale consists of 30 items rated 0 to 2 points. Minimum value 0 and maximum value 60. Higher scores indicate higher social skills.
Time Frame
Immediately after the intervention
Title
Social skills at 3 months
Description
Social Skills Questionnaire (SSQ). It measures children's social functioning, as reflected by specific behavioural responses during interaction with another person. The scale consists of 30 items rated 0 to 2 points. Minimum value 0 and maximum value 60. Higher scores indicate higher social skills.
Time Frame
3 months after the intervention
Title
Social skills at 6 months
Description
Social Skills Questionnaire (SSQ). It measures children's social functioning, as reflected by specific behavioural responses during interaction with another person. The scale consists of 30 items rated 0 to 2 points. Minimum value 0 and maximum value 60. Higher scores indicate higher social skills.
Time Frame
6 months after the intervention
Title
Social skills at 12 months
Description
Social Skills Questionnaire (SSQ). It measures children's social functioning, as reflected by specific behavioural responses during interaction with another person. The scale consists of 30 items rated 0 to 2 points. Minimum value 0 and maximum value 60. Higher scores indicate higher social skills.
Time Frame
12 months after the intervention
Title
Baseline social worries
Description
Social Worries Questionnaire (SSW). It measures children's social worries, in terms of anxiety about and avoidance of specific social situations in which social evaluation or scrutiny by others is likely to occur. The scale consists of 12 items rated 0 to 2 points. Minimum value 0 and maximum value 24. Higher scores indicate higher social worries.
Time Frame
Baseline
Title
Social worries immediately after the intervention
Description
Social Worries Questionnaire (SSW). It measures children's social worries, in terms of anxiety about and avoidance of specific social situations in which social evaluation or scrutiny by others is likely to occur. The scale consists of 12 items rated 0 to 2 points. Minimum value 0 and maximum value 24. Higher scores indicate higher social worries.
Time Frame
Immediately after the intervention
Title
Social worries at 3 months
Description
Social Worries Questionnaire (SSW). It measures children's social worries, in terms of anxiety about and avoidance of specific social situations in which social evaluation or scrutiny by others is likely to occur. The scale consists of 12 items rated 0 to 2 points. Minimum value 0 and maximum value 24. Higher scores indicate higher social worries.
Time Frame
3 months after the intervention
Title
Social worries at 6 months
Description
Social Worries Questionnaire (SSW). It measures children's social worries, in terms of anxiety about and avoidance of specific social situations in which social evaluation or scrutiny by others is likely to occur. The scale consists of 12 items rated 0 to 2 points. Minimum value 0 and maximum value 24. Higher scores indicate higher social worries.
Time Frame
6 months after the intervention
Title
Social worries at 12 months
Description
Social Worries Questionnaire (SSW). It measures children's social worries, in terms of anxiety about and avoidance of specific social situations in which social evaluation or scrutiny by others is likely to occur. The scale consists of 12 items rated 0 to 2 points. Minimum value 0 and maximum value 24. Higher scores indicate higher social worries.
Time Frame
12 months after the intervention
Title
Baseline cognitive emotion regulation strategies
Description
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.
Time Frame
Baseline
Title
Cognitive emotion regulation strategies immediately after the intervention
Description
Measured by the Cognitive Emotion Regulation Questionnaire children self-report (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.
Time Frame
Immediately after the intervention
Title
Cognitive emotion regulation strategies at 3 months
Description
Measured by the Cognitive Emotion Regulation Questionnaire children self-report (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.
Time Frame
3 months after the intervention
Title
Cognitive emotion regulation strategies at 6 months
Description
Measured by the Cognitive Emotion Regulation Questionnaire children self-report (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.
Time Frame
6 months after the intervention
Title
Cognitive emotion regulation strategies at 12 months
Description
Measured by the Cognitive Emotion Regulation Questionnaire children self-report (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.
Time Frame
12 months after the intervention
Title
Baseline parental depression, anxiety and stress symptoms
Description
Measured by the Depression Anxiety Stress Scales - short version (DASS-21). It contains a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress. Each of the three DASS-21 scales contains 7 items, divided into subscales with similar content. The depression scale assesses dysphoria, hopelessness, devaluation of life, self-deprecation, lack of interest / involvement, anhedonia and inertia. The anxiety scale assesses autonomic arousal, skeletal muscle effects, situational anxiety, and subjective experience of anxious affect. The stress scale is sensitive to levels of chronic nonspecific arousal. It assesses difficulty relaxing, nervous arousal, and being easily upset / agitated, irritable / over-reactive and impatient. Scores for depression, anxiety and stress are calculated by summing the scores for the relevant items.
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children aged 8 - 12 years old. Presence of emotional symptoms. This will be assessed by means of a screening test to be completed by parents (Spanish version of the Strenghts and Difficulties Questionnaire [SDQ]). The cut-off point for children to be included in the study will be that they present a score above 4 on the Emotional Problems subscale of the SDQ questionnaire. Speaking, reading, writing and understanding Spanish. Exclusion Criteria: Intellectual disability, behavioral symptoms, or autism spectrum symptoms whose severity precluded continued treatment. Being receiving current psychological or pharmacological treatment for anxiety and/or depression. Not accepting or revoking informed consent to participate in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Teresa Galán Luque
Phone
+34965222071
Email
tgalan@umh.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mireia Orgilés Amorós
Organizational Affiliation
Miguel Hernandez University of Elche
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Health Psychology. Miguel Hernandez University of Elche
City
Elche
State/Province
Alicante
ZIP/Postal Code
03202
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Teresa Galán Luque
Phone
965222071
Email
tgalan@umh.es

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All IPD
IPD Sharing Time Frame
Starting after finishing all analysis and publication.
IPD Sharing Access Criteria
Upon request and verification by the principal investigator to consult the available data. The use of the data for distribution in any format is not permitted.
Citations:
PubMed Identifier
24999861
Citation
Essau CA, Olaya B, Sasagawa S, Pithia J, Bray D, Ollendick TH. Integrating video-feedback and cognitive preparation, social skills training and behavioural activation in a cognitive behavioural therapy in the treatment of childhood anxiety. J Affect Disord. 2014;167:261-7. doi: 10.1016/j.jad.2014.05.056. Epub 2014 Jun 4.
Results Reference
background
PubMed Identifier
31078836
Citation
Essau CA, Sasagawa S, Jones G, Fernandes B, Ollendick TH. Evaluating the real-world effectiveness of a cognitive behavior therapy-based transdiagnostic program for emotional problems in children in a regular school setting. J Affect Disord. 2019 Jun 15;253:357-365. doi: 10.1016/j.jad.2019.04.036. Epub 2019 Apr 16.
Results Reference
background
PubMed Identifier
31334667
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. doi: 10.1080/10615806.2019.1645836. Epub 2019 Jul 23.
Results Reference
background
PubMed Identifier
31733917
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 Affect Disord. 2020 Feb 1;262:258-266. doi: 10.1016/j.jad.2019.11.002. Epub 2019 Nov 4.
Results Reference
background
PubMed Identifier
33882156
Citation
Melero S, Orgiles M, Espada JP, Morales A. Spanish version of Super Skills for Life in individual modality: Improvement of children's emotional well-being from a transdiagnostic approach. J Clin Psychol. 2021 Oct;77(10):2187-2202. doi: 10.1002/jclp.23148. Epub 2021 Apr 21.
Results Reference
background
PubMed Identifier
32249749
Citation
Fernandez-Martinez I, Morales A, Espada JP, Orgiles M. Effects of Super Skills for Life on the social skills of anxious children through video analysis. Psicothema. 2020 May;32(2):229-236. doi: 10.7334/psicothema2019.240.
Results Reference
background
PubMed Identifier
33918640
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.
Results Reference
background
PubMed Identifier
33511861
Citation
Melero S, Morales A, Espada JP, Orgiles M. Improving Social Performance Through Video-feedback with Cognitive Preparation in Children with Emotional Problems. Behav Modif. 2022 Jul;46(4):755-781. doi: 10.1177/0145445521991098. Epub 2021 Jan 29.
Results Reference
background
PubMed Identifier
27614301
Citation
Escribano S, Espada JP, Orgiles M, Morales A. Implementation fidelity for promoting the effectiveness of an adolescent sexual health program. Eval Program Plann. 2016 Dec;59:81-87. doi: 10.1016/j.evalprogplan.2016.08.008. Epub 2016 Aug 31.
Results Reference
background
PubMed Identifier
32325756
Citation
Orgiles M, Melero S, Fernandez-Martinez I, Espada JP, Morales A. Effectiveness of Video-Feedback with Cognitive Preparation in Improving Social Performance and Anxiety through Super Skills for Life Programme Implemented in a School Setting. Int J Environ Res Public Health. 2020 Apr 18;17(8):2805. doi: 10.3390/ijerph17082805.
Results Reference
background
Links:
URL
https://www.superskillsforlife.com/
Description
Super Skills for Life original program's webpage
URL
https://superskills.umh.es/
Description
Programa Super Skills for Life - Spanish webpage

Learn more about this trial

Effectiveness of Individual and Multimedia Versions of Super Skills for Life in Children

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