- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05574491
Effectiveness of Traditional and Computerized Versions of Super Skills for Life in Children
Comparative Effectiveness of Traditional and Computerized Versions of the Transdiagnostic Program Super Skills for Life in Children Aged 8-12 Years: a Randomized Controlled Trial
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 computerized versions on internalizing symptoms in Spanish children between 8 and 12 years of age.
Study Overview
Status
Conditions
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 computerized versions of SSL).
Parents and children from the two groups will complete the same measures at baseline and post-treatment. They will also complete these measures at 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 on depressive symptoms, anxiety symptoms, interference of anxiety on child's life, self-esteem, social skills, social worries, and cognitive emotional regulation.
The investigators will also assess these variables in the intervention group at 6 months and 12 months follow-up.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Alicante
-
Elche, Alicante, Spain, 03202
- Department of Health Psychology. Miguel Hernandez University of Elche
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Children aged 8 - 12 years old.
- Presence of emotional symptoms, which will be assessed using the SCAS and the MFQ, parent versions. The cut-off point for inclusion in the study is a score equal to or above 25 on the SCAS and/or equal to or above 20 on the MFQ.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Super Skills for Life intervention group: traditional version
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.
|
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. |
|
Experimental: Super Skills for Life intervention group: computerized version
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/. |
Structured and manualized intervention with a manual for the therapist and multimedia material for the children.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Baseline children's reported anxiety symptoms
Time Frame: Baseline
|
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
|
|
Children's reported anxiety symptoms immediately after the intervention
Time Frame: 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.
|
Immediately after the intervention
|
|
Children's reported anxiety symptoms at 6 months
Time Frame: 6 months 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.
|
6 months after the intervention
|
|
Children's reported anxiety symptoms at 12 months
Time Frame: 12 months 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.
|
12 months after the intervention
|
|
Baseline parent-reported anxiety symptoms
Time Frame: Baseline
|
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
|
|
Parent-reported anxiety symptoms immediately after the intervention
Time Frame: 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.
|
Immediately after the intervention
|
|
Parent-reported anxiety symptoms immediately at 6 months
Time Frame: 6 months 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.
|
6 months after the intervention
|
|
Parent-reported anxiety symptoms immediately at 12 months
Time Frame: 12 months 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.
|
12 months after the intervention
|
|
Baseline children's reported depressive symptoms
Time Frame: Baseline
|
Measured by Mood and Feelings Questionnaire - Short Version (MFQS).
It assess depressive symptoms experienced in the past two weeks.
The MFQS provides an overall score (minimum value 0, maximum value 26).
Higher scores indicate more severe symptoms.
|
Baseline
|
|
Children's reported depressive symptoms immediately after the intervention
Time Frame: 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.
|
Immediately after the intervention
|
|
Children's reported depressive symptoms at 6 months
Time Frame: 6 months after the intervention
|
Measured by Mood and Feelings Questionnaire - Short Version (MFQS).
It assess depressive symptoms experienced in the past two weeks.
The MFQS provides an overall score (minimum value 0, maximum value 26).
Higher scores indicate more severe symptoms.
|
6 months after the intervention
|
|
Children's reported depressive symptoms at 12 months
Time Frame: 12 months after the intervention
|
Measured by Mood and Feelings Questionnaire - Short Version (MFQS).
It assess depressive symptoms experienced in the past two weeks.
The MFQS provides an overall score (minimum value 0, maximum value 26).
Higher scores indicate more severe symptoms.
|
12 months after the intervention
|
|
Baseline parent-reported depressive symptoms
Time Frame: Baseline
|
Measured by Mood and Feelings Questionnaire Parent-Report (MFQ-P).
It assess depressive symptoms experienced in the past two weeks.
The MFQS provides an overall score (minimum value 0, maximum value 68).
Higher scores indicate more severe symptoms.
|
Baseline
|
|
Parent-reported depressive symptoms immediately after the intervention
Time Frame: Immediately after the intervention
|
Measured by Mood and Feelings Questionnaire Parent-Report (MFQ-P).
It assess depressive symptoms experienced in the past two weeks.
The MFQS provides an overall score (minimum value 0, maximum value 68).
Higher scores indicate more severe symptoms.
|
Immediately after the intervention
|
|
Parent-reported depressive symptoms immediately at 6 months
Time Frame: 6 months after the intervention
|
Measured by Mood and Feelings Questionnaire Parent-Report (MFQ-P).
It assess depressive symptoms experienced in the past two weeks.
The MFQS provides an overall score (minimum value 0, maximum value 68).
Higher scores indicate more severe symptoms.
|
6 months after the intervention
|
|
Parent-reported depressive symptoms immediately at 12 months
Time Frame: 12 months after the intervention
|
Measured by Mood and Feelings Questionnaire Parent-Report (MFQ-P).
It assess depressive symptoms experienced in the past two weeks.
The MFQS provides an overall score (minimum value 0, maximum value 68).
Higher scores indicate more severe symptoms.
|
12 months after the intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Baseline children's anxiety-related interference
Time Frame: Baseline
|
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
|
|
Children's anxiety-related interference immediately after the intervention
Time Frame: 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.
|
Immediately after the intervention
|
|
Children's anxiety-related interference at 6 months
Time Frame: 6 months 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.
|
6 months after the intervention
|
|
Children's anxiety-related interference at 12 months
Time Frame: 12 months 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.
|
12 months after the intervention
|
|
Baseline parent-reported anxiety-related interference
Time Frame: Baseline
|
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
|
|
Parent-reported anxiety-related interference immediately after the intervention
Time Frame: 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.
|
Immediately after the intervention
|
|
Parent-reported anxiety-related interference at 6 months
Time Frame: 6 months 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.
|
6 months after the intervention
|
|
Parent-reported anxiety-related interference at 12 months
Time Frame: 12 months 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.
|
12 months after the intervention
|
|
Baseline self-esteem
Time Frame: Baseline
|
Self-Concept Form 5 (AF-5).
It measures global satisfaction with self-concept (minimum value 0 and maximum value 120) and five dimensions (minimum value 0 and maximum value 24): Social (performance in social relationships); Academic/Professional (student/worker role); Emotional (perception of emotional state in general and in specific situations); Family (participation and integration into the family unit); and Physical self-concept (appearance and physical condition).
Higher scores indicate greater satisfaction with self-image.
|
Baseline
|
|
Self-esteem immediately after the intervention
Time Frame: 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.
|
Immediately after the intervention
|
|
Self-esteem at 6 months
Time Frame: 6 months after the intervention
|
Self-Concept Form 5 (AF-5).
It measures global satisfaction with self-concept (minimum value 0 and maximum value 120) and five dimensions (minimum value 0 and maximum value 24): Social (performance in social relationships); Academic/Professional (student/worker role); Emotional (perception of emotional state in general and in specific situations); Family (participation and integration into the family unit); and Physical self-concept (appearance and physical condition).
Higher scores indicate greater satisfaction with self-image.
|
6 months after the intervention
|
|
Self-esteem at 12 months
Time Frame: 12 months after the intervention
|
Self-Concept Form 5 (AF-5).
It measures global satisfaction with self-concept (minimum value 0 and maximum value 120) and five dimensions (minimum value 0 and maximum value 24): Social (performance in social relationships); Academic/Professional (student/worker role); Emotional (perception of emotional state in general and in specific situations); Family (participation and integration into the family unit); and Physical self-concept (appearance and physical condition).
Higher scores indicate greater satisfaction with self-image.
|
12 months after the intervention
|
|
Baseline social skills
Time Frame: Baseline
|
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 skills immediately after the intervention
Time Frame: 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.
|
Immediately after the intervention
|
|
Social skills at 6 months
Time Frame: 6 months 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.
|
6 months after the intervention
|
|
Social skills at 12 months
Time Frame: 12 months 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.
|
12 months after the intervention
|
|
Baseline social worries
Time Frame: Baseline
|
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
|
|
Social worries immediately after the intervention
Time Frame: 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.
|
Immediately after the intervention
|
|
Social worries at 6 months
Time Frame: 6 months 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.
|
6 months after the intervention
|
|
Social worries at 12 months
Time Frame: 12 months 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.
|
12 months after the intervention
|
|
Baseline cognitive emotion regulation strategies
Time Frame: Baseline
|
Measured by the Cognitive Emotion Regulation Questionnaire (CERQ-k).
CERQ-k consists of 36 items that measure nine cognitive coping strategies.
Each subscale represents one cognitive coping strategy: Self-blame, Other blame, Acceptance, Planning, Positive refocusing, Rumination or focus on thought, Positive reappraisal, Putting into perspective, and Catastrophizing.
The response format of the items is a five point scale from (almost) never to (almost) always.
Each item is rated 1 to 5 points.
Minimum value 36 and maximum value 180.
|
Baseline
|
|
Cognitive emotion regulation strategies immediately after the intervention
Time Frame: 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.
|
Immediately after the intervention
|
|
Cognitive emotion regulation strategies at 6 months
Time Frame: 6 months 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.
|
6 months after the intervention
|
|
Cognitive emotion regulation strategies at 12 months
Time Frame: 12 months 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.
|
12 months after the intervention
|
|
Baseline parental depression, anxiety and stress symptoms
Time Frame: Baseline
|
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. |
Baseline
|
|
Baseline parental depression, anxiety and stress symptoms
Time Frame: Immediately after the intervention
|
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. |
Immediately after the intervention
|
|
Baseline parental depression, anxiety and stress symptoms
Time Frame: 6 months after the intervention
|
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. |
6 months after the intervention
|
|
Baseline parental depression, anxiety and stress symptoms
Time Frame: 12 months after the intervention
|
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. |
12 months after the intervention
|
Collaborators and Investigators
Investigators
- Principal Investigator: Mireia Orgilés Amorós, Miguel Hernández University of Elche
Publications and helpful links
General Publications
- 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.
- 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.
- Orgiles M, Fernandez-Martinez I, Espada JP, Morales A. Spanish version of Super Skills for Life: short- and long-term impact of a transdiagnostic prevention protocol targeting childhood anxiety and depression. Anxiety Stress Coping. 2019 Nov;32(6):694-710. doi: 10.1080/10615806.2019.1645836. Epub 2019 Jul 23.
- Fernandez-Martinez I, Orgiles M, Morales A, Espada JP, Essau CA. One-Year follow-up effects of a cognitive behavior therapy-based transdiagnostic program for emotional problems in young children: A school-based cluster-randomized controlled trial. J Affect Disord. 2020 Feb 1;262:258-266. doi: 10.1016/j.jad.2019.11.002. Epub 2019 Nov 4.
- Melero S, 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 220118115011
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
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Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Depressive Disorder
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Aalborg University HospitalRecruitingDepressive Disorder | Depression | Depressive Episode | Depressive Disorders | Depressive Episodes | Depression - Major Depressive Disorder | Depressive Disorder, Major Depressive DisorderDenmark
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Sheba Medical CenterNot yet recruiting
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ACADIA Pharmaceuticals Inc.RecruitingACP-211 Monotherapy for Major Depressive Disorder With Inadequate Antidepressant Response (NORLIGHT)Depressive Disorder, Treatment-Resistant | Major Depressive Disorder (MDD)United States
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Rotman Research Institute at BaycrestRecruitingMajor Depressive Disorder (MDD)Canada
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Hospital Universitari Vall d'Hebron Research InstituteRecruitingDepression - Major Depressive Disorder | Depression Chronic | Treatment-Resistant Major Depressive Disorder | Depression DisorderSpain
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Second Affiliated Hospital of Tsinghua UniversityNot yet recruiting
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First People's Hospital of HangzhouNot yet recruitingMajor Depressive Disorder
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University of Wisconsin, MadisonNational Institute of Mental Health (NIMH)Recruiting
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Shandong Provincial HospitalShandong UniversityRecruiting
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Engrail Therapeutics INCCompletedMajor Depressive DisorderUnited Kingdom
Clinical Trials on Super Skills for Life: traditional version
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Universidad Miguel Hernandez de ElcheCompletedDepressive Disorder | Mood Disorders | Anxiety Disorders | Trauma and Stressor Related Disorders | Emotional Disorder | Depressive Symptoms | Anxiety Disorders and SymptomsSpain
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Universidad Miguel Hernandez de ElcheMinisterio de Economía y Competitividad, SpainCompletedDepressive Disorder | Mood Disorders | Anxiety Disorders | Emotional Disorder | Depressive Symptoms | Child Mental Disorder | Anxiety Disorders and SymptomsSpain
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University of RoehamptonUniversity of Malaya; Universidad Complutense de Madrid; Saglik Bilimleri Universitesi and other collaboratorsRecruitingAnxiety | Depression in AdolescenceMalaysia
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Fatima Jinnah Women UniversityCompletedSocial Skills | Behavioral Problems | Emotional Problems | Childhood Anxiety | Childhood Depression | Quality of Life (QOL) | Low Self-EsteemPakistan
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Universidad Autonoma de Baja CaliforniaNot yet recruitingInstitutionalizationMexico
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NYU Langone HealthNational Institute of Mental Health (NIMH)CompletedSocial Anxiety DisorderUnited States
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Carnegie Mellon UniversityUniversity of Pittsburgh; West Virginia UniversityCompletedPregnancy | Sexually Transmitted Infections | Automobile AccidentsUnited States
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Seoul National University Bundang HospitalSeoul St. Mary's Hospital; Kyung Hee University HospitalActive, not recruiting
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London School of Economics and Political ScienceBill and Melinda Gates Foundation; Aga Khan UniversityCompletedDepression | Domestic Violence | Intimate Partner Violence | Battered Women | Mental Health Issue | Gender-based Violence | Rape Sexual AssaultPakistan
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Koç UniversityActive, not recruitingDepression | Anxiety | Psychological Distress | Secondary TraumaTurkey