Effectiveness of Traditional and Computerized Versions of Super Skills for Life in Children

NCT05574491 | Unknown

• 1 other identifier: 220118115011
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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 computerized versions on internalizing symptoms in Spanish children between 8 and 12 years of age.

Conditions

Depressive Disorder; Depressive Symptoms; Anxiety Disorders; Anxiety Disorders and Symptoms; Mood Disorders; Emotional Disorder

Outcome Measures

Primary Outcomes (16)

• 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.

  Baseline

• 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.

  Immediately after the intervention

• Children's reported anxiety symptoms at 6 months

  Measured by Spence Children's Anxiety Scale Child Report (SCAS). SCAS measures symptoms severity of the DSM-IV anxiety disorders in children (subscales: total, panic and agoraphobia, generalized anxiety disorder, obsessive-compulsive disorder, social phobia, separation anxiety and specific fears). Symptom frequency is recorded on a 3-point Likert scale from 0 (never) to 3 (always). This yields a minimum possible score of 0 and a maximum possible score of 114. Higher scores indicating greater severity of symptoms.

  6 months after the intervention

• 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.

  12 months after the intervention

• 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.

  Baseline

• 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.

  Immediately after the intervention

• 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.

  6 months after the intervention

• 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.

  12 months after the intervention

• 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.

  Baseline

• 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.

  Immediately after the intervention

• 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.

  6 months after the intervention

• 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.

  12 months after the intervention

• Baseline parent-reported depressive symptoms

  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

  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

  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

  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 Outcomes (28)

• Baseline children's anxiety-related interference

  Baseline

• Children's anxiety-related interference immediately after the intervention

  Immediately after the intervention

• Children's anxiety-related interference at 6 months

  6 months after the intervention

• Children's anxiety-related interference at 12 months

  12 months after the intervention

• Baseline parent-reported anxiety-related interference

  Baseline

Study Arms (2)

Super Skills for Life intervention group: traditional version

EXPERIMENTAL

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.

Behavioral: Super Skills for Life: traditional version

Super Skills for Life intervention group: computerized version

EXPERIMENTAL

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/.

Behavioral: Super Skills for Life: computerized version

Interventions

Super Skills for Life: traditional version BEHAVIORAL

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.

Super Skills for Life intervention group: traditional version

Super Skills for Life: computerized version BEHAVIORAL

Structured and manualized intervention with a manual for the therapist and multimedia material for the children.

Super Skills for Life intervention group: computerized version

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 8 - 12 years old.
• Speaking, reading, writing and understanding Spanish.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Miguel Hernandez de Elche: lead

Study Sites (1)

Department of Health Psychology. Miguel Hernandez University of Elche

Elche, Alicante, 03202, Spain

Location

Related Publications (10)

• 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.

  PMID: 24999861 BACKGROUND

• 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.

  PMID: 31078836 BACKGROUND

• 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.

  PMID: 31334667 BACKGROUND

• 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.

  PMID: 31733917 BACKGROUND

• 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.

  PMID: 33882156 BACKGROUND

• 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.

  PMID: 32249749 BACKGROUND

• 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.

  PMID: 33918640 BACKGROUND

• 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.

  PMID: 33511861 BACKGROUND

• 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.

  PMID: 27614301 BACKGROUND

• 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.

  PMID: 32325756 BACKGROUND

Related Links

• Super Skills for Life original program's webpage
• Programa Super Skills for Life - Spanish webpage

MeSH Terms

Conditions

Depressive Disorder; Depression; Anxiety Disorders; Mood Disorders

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Mireia Orgilés Amorós

  Miguel Hernandez University of Elche

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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 computerized versions of SSL). 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.

Study Record Dates

• First Submitted: October 6, 2022
• First Posted: October 10, 2022
• Study Start: February 7, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: February 1, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Starting after finishing all analysis and publication.
• 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.

Locations

ES (1)