Super Skills for Life Effectiveness in the Online Modality

May 8, 2023 updated by: Mireia Orgilés Amorós, Universidad Miguel Hernandez de Elche

Adaptación y evaluación Del Programa transdiagnóstico Super Skills for Life Aplicado Online Para niños Con Problemas Interiorizados

The study aims to evaluate the effectiveness of the transdiagnostic program Super Skills for Life (SSL). This protocol targets children aged 8 to 12 with emotional problems (anxiety, 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 present research focuses on assessing the effectiveness of SSL applied online (through a virtual platform).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

After selecting the children based on the online questionnaires completed by the parents (preintervention assessment) and inclusion/exclusion criteria, they were randomly allocated to the conditions of the intervention group and the wait-list control group. Parents and children from both groups completed the same measures at baseline, post-treatment, and 12 months follow-up. Children in the experimental group received the SSL program by the virtual platform.

The objective of the study is to evaluate the benefits of the Super Skills for Life protocol applied online. For this purpose, the researchers will test to what extent the experimental group decreases its anxiety symptoms, anxiety impairment, depressive symptoms, behavioral problems, hyperactivity/inattention, and peer relationship problems, and increase its self-esteem and prosocial behaviors, compared to the control group.

In conclusion, the purpose of the study is to explore whether SSL implemented online can be a cost-effective psychological intervention to prevent emotional problems in Spanish children.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Alicante
      • Elche, Alicante, Spain, 03202
        • Universidad Miguel Hernandez de Elche

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 12 years (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Children aged 8-12
  • Presenting subclinical symptoms of emotional problems (anxiety, depression)
  • Speaking, reading, writing, and understanding Spanish.
  • Not receiving psychological or pharmacological treatment for emotional and/or behavioral problems

Exclusion Criteria:

  • Had a psychiatric diagnosis already established
  • Presenting a severe developmental disorder (intellectual disability, autism spectrum disorder, etc).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
Super Skills for Life intervention
Behavioral: Super Skills for Life program
Children in the experimental group received eight sessions of the Super Skills for Life protocol. The intervention was implemented using a structured manual for the therapist and a workbook for the children [Orgilés, M., Espada, J.P., Ollendick, T.H. & Essau, C. (2022). Programa Super Skills. Manual del aplicador. Elche, ES: Universidad Miguel Hernández]. The intervention was administered via an online virtual platform for eight weeks, with each session lasting approximately one hour.
No Intervention: Wait-list group
Children in this group did not receive any phycological (public or private) intervention during the eight-week duration of the SSL program. They were informed that children in this group will receive the intervention once the follow-up visit is completed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline depression symptoms to immediately after the intervention
Time Frame: 1 year after the intervention
Measured by the Mood and Feelings Questionnaire (MFQ-C; short version), a screening tool for depression in children aged 6-17 years. Children must report their feelings and behaviors over the previous 2 weeks. The sum of all items provides a total measure of depression (score range: 0-26), and the higher this score is, the more severe the symptoms are.
1 year after the intervention
Depression symptoms at 1 year
Time Frame: 1 year after the intervention
Measured by the Mood and Feelings Questionnaire (MFQ-C; short version), a screening tool for depression in children aged 6-17 years. Children must report their feelings and behaviors over the previous 2 weeks. The sum of all items provides a total measure of depression (score range: 0-26), and the higher this score is, the more severe the symptoms are.
1 year after the intervention
Change from baseline parent-reported depression to immediately after the intervention
Time Frame: baseline and immediately after the intervention
Measured by the Mood and Feelings Questionnaire (MFQ-P; short version), a screening tool for depression in children aged 6-17 years. Parents must inform about their children's feelings and behaviors over the previous 2 weeks. The sum of all items provides a total measure of depression (score range: 0-26), and the higher this score is, the more severe the symptoms are.
baseline and immediately after the intervention
Parent-reported depression at 1 year
Time Frame: 1 year after the intervention
Measured by the Mood and Feelings Questionnaire (MFQ-P; short version), a screening tool for depression in children aged 6-17 years. Parents must inform about their children's feelings and behaviors over the previous 2 weeks. The sum of all items provides a total measure of depression (score range: 0-26), and the higher this score is, the more severe the symptoms are.
1 year after the intervention
Change from baseline children's reported anxiety symptoms to immediately after the intervention
Time Frame: baseline and immediately after the intervention
Measured by Spence Children's Anxiety Scale Child Report (SCAS; short version). 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). This yields a minimum possible score of 0 and a maximum possible score of 24. Higher scores indicate greater severity of symptoms
baseline and immediately after the intervention
Change from baseline parent-reported anxiety symptoms to immediately after the intervention
Time Frame: baseline and immediately after the intervention
Measured by Spence Children's Anxiety Scale Parent Report (SCAS-P; short version). 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). This yields a minimum possible score of 0 and a maximum possible score of 24. Higher scores indicate greater severity of symptoms.
baseline and immediately after the intervention
Children's reported anxiety symptoms at 1 year
Time Frame: 1 year after the intervention
Measured by Spence Children's Anxiety Scale Child Report (SCAS; short version). 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). This yields a minimum possible score of 0 and a maximum possible score of 24. Higher scores indicate greater severity of symptoms
1 year after the intervention
Parent-reported anxiety at 1 year
Time Frame: 1 year after the intervention
Measured by Spence Children's Anxiety Scale Parent Report (SCAS-P; short version). 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). This yields a minimum possible score of 0 and a maximum possible score of 24. Higher scores indicate greater severity of symptoms.
1 year after the intervention
Change from baseline children's reported psychological adjustment to immediately after the intervention
Time Frame: baseline and immediately after the intervention
Measured by Strengths and Difficulties Questionnaire Child Report (SDQ). It was designed to measure children's overall difficulties (minimum value 0 and maximum value 40) and positive attributes across five subscales (minimum value 0 and maximum value 10): Emotional symptoms (e.g., anxiety and depression), Conduct problems, Hyperactivity/Inattention, Peer relationships (difficulties), and Pro-social behavior. Higher scores indicate higher levels of difficulties, except on the prosocial subscale, where higher scores reflect a more positive attribute.
baseline and immediately after the intervention
Change from baseline parent-reported psychological adjustment to immediately after the intervention
Time Frame: baseline and immediately after the intervention
Measured by Strengths and Difficulties Questionnaire Parental Report (SDQ-P). It was designed to measure children's overall difficulties (minimum value 0 and maximum value 40) and positive attributes across five subscales (minimum value 0 and maximum value 10): Emotional symptoms (e.g., anxiety and depression), Conduct problems, Hyperactivity/Inattention, Peer relationships (difficulties), and Pro-social behavior. Higher scores indicate higher levels of difficulties, except on the prosocial subscale, where higher scores reflect a more positive attribute.
baseline and immediately after the intervention
Children's reported psychological adjustment at 1 year
Time Frame: 1 year after the intervention
Measured by Strengths and Difficulties Questionnaire Child Report (SDQ). It was designed to measure children's overall difficulties (minimum value 0 and maximum value 40) and positive attributes across five subscales (minimum value 0 and maximum value 10): Emotional symptoms (e.g., anxiety and depression), Conduct problems, Hyperactivity/Inattention, Peer relationships (difficulties), and Pro-social behavior. Higher scores indicate higher levels of difficulties, except on the prosocial subscale, where higher scores reflect a more positive attribute.
1 year after the intervention
Parent-reported psychological adjustment at 1 year
Time Frame: 1 year after the intervention
Measured by Strengths and Difficulties Questionnaire Parental Report (SDQ-P). It was designed to measure children's overall difficulties (minimum value 0 and maximum value 40) and positive attributes across five subscales (minimum value 0 and maximum value 10): Emotional symptoms (e.g., anxiety and depression), Conduct problems, Hyperactivity/Inattention, Peer relationships (difficulties), and Pro-social behavior. Higher scores indicate higher levels of difficulties, except on the prosocial subscale, where higher scores reflect a more positive attribute.
1 year after the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline self-concept to immediately after the intervention
Time Frame: baseline and immediately after the intervention
Measured by the Self-Concept Form 5 (AF-5). It measures global satisfaction with self-concept (minimum value 0 and maximum value 120) and five dimensions (minimum value 0 and maximum value 24): Social (performance in social relationships); Academic/Professional (student/worker role); Emotional (perception of emotional state in general and in specific situations); Family (participation and integration into the family unit); and Physical self-concept (appearance and physical condition). Higher scores indicate greater satisfaction with self-image.
baseline and immediately after the intervention
Children's self-concept at 1 year
Time Frame: 1 year after the intervention
Measured by the Self-Concept Form 5 (AF-5). It measures global satisfaction with self-concept (minimum value 0 and maximum value 120) and five dimensions (minimum value 0 and maximum value 24): Social (performance in social relationships); Academic/Professional (student/worker role); Emotional (perception of emotional state in general and in specific situations); Family (participation and integration into the family unit); and Physical self-concept (appearance and physical condition). Higher scores indicate greater satisfaction with self-image.
1 year after the intervention
Change from baseline social worries to immediately after the intervention
Time Frame: baseline and immediately after the intervention
Measured by the Social Worries Questionnaire for pupils (SWQ-PU). It evaluates children's worries in different social situations. In general, the higher the score, the more severe the symptomatology.
baseline and immediately after the intervention
Children's social worries at 1 year
Time Frame: 1 year after the intervention
Measured by the Social Worries Questionnaire for pupils (SWQ-PU). It evaluates children's worries in different social situations. In general, the higher the score, the more severe the symptomatology.
1 year after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Miguel Hernandez de Elche

Collaborators

Ministerio de Economía y Competitividad, Spain

Investigators

  • Principal Investigator: Silvia Melero, PhD, Universidad Miguel Hernandez de Elche
  • Study Director: Mireia Orgilés, Professor, Universidad Miguel Hernandez de Elche
  • Study Director: José Pedro Espada, Professor, Universidad Miguel Hernandez de Elche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2017

Primary Completion (Actual)

December 1, 2022

Study Completion (Actual)

December 1, 2022

Study Registration Dates

First Submitted

October 17, 2022

First Submitted That Met QC Criteria

October 17, 2022

First Posted (Actual)

October 21, 2022

Study Record Updates

Last Update Posted (Actual)

May 10, 2023

Last Update Submitted That Met QC Criteria

May 8, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DPS.MO.01.17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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