NCT05589090

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2017

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

October 17, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 21, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

May 10, 2023

Status Verified

May 1, 2023

Enrollment Period

5.2 years

First QC Date

October 17, 2022

Last Update Submit

May 8, 2023

Conditions

Keywords

Super Skills for Lifeemotional problemsinternalizing problemschildrenanxietydepression

Outcome Measures

Primary Outcomes (12)

  • Change from baseline depression symptoms to immediately 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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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 Outcomes (4)

  • Change from baseline self-concept to immediately after the intervention

    baseline and immediately after the intervention

  • Children's self-concept at 1 year

    1 year after the intervention

  • Change from baseline social worries to immediately after the intervention

    baseline and immediately after the intervention

  • Children's social worries at 1 year

    1 year after the intervention

Study Arms (2)

Intervention group

EXPERIMENTAL

Super Skills for Life intervention

Behavioral: Super Skills for Life program

Wait-list group

NO INTERVENTION

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.

Interventions

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.

Intervention group

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Miguel Hernández de Elche

Elche, Alicante, 03202, Spain

Location

Related Publications (18)

  • Essau, C. A., & Ollendick, T. H. (2013). The Super Skills for Life Programme. London, Reino Unido: University of Roehampton

    BACKGROUND
  • 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: 24999861BACKGROUND
  • 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: 31078836BACKGROUND
  • Fernández-Martínez, I., Espada, J. P., & Orgilés, M. (2019). Super Skills for Life: Eficacia de un programa transdiagnóstico de prevención indicada para los problemas emocionales infantiles. Revista de Psicología Clínica con Niños y Adolescentes, 6(3), 24-31. https://doi.org/10.21134/rpcna.2019.06.3.3

    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: 31334667BACKGROUND
  • Fernandez-Martinez I, Morales A, Espada JP, Essau CA, Orgiles M. Effectiveness of the program Super Skills For Life in reducing symptoms of anxiety and depression in young Spanish children. Psicothema. 2019 Aug;31(3):298-304. doi: 10.7334/psicothema2018.336.

    PMID: 31292045BACKGROUND
  • 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: 31733917BACKGROUND
  • Diego-Castaño, S., Prieto-Moya, J., Hermosín, N., & Orgilés, M. (2019). Eficacia del programa Super Skills en población clínica: un estudio piloto. 5 Congreso International de Psicología Clinica y Salud con Niños y Adolescentes, Oviedo, Spain. ISSN: 2695-4664

    BACKGROUND
  • Melero, S., Morales, A., & Orgilés, M. (2019, noviembre). Eficacia de la aplicación individual del programa Super Skills for Life para reducir síntomas emocionales en menores. 5 Congreso International de Psicología Clinica y Salud con Niños y Adolescentes, Oviedo, Spain. ISSN: 2695-4664

    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: 32249749BACKGROUND
  • 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: 32325756BACKGROUND
  • Orgilés, M., Garrigós, E., Espada, J. P., & Morales, A. (2020). How does a CBT-based transdiagnostic program for separation anxiety symptoms work in children?: Effects of Super Skills for Life. Revista de Psicología Clínica con Niños y Adolescentes, 7(2), 9-15. https://doi.org/10.21134/rpcna.2020.07.2.1

    BACKGROUND
  • Orgilés, M., Espada, J. P, & Morales, A. (2020). How Super Skills for Life may help children to cope with the COVID-19: Psychological impact and coping styles after the program. Revista de Psicología Clínica con Niños y Adolescentes, 7(3), 88-93. https://doi.org/10.21134/rpcna.2020.mon.2048

    BACKGROUND
  • Melero, S., Orgilés, M., Fernández-Martínez, I., Espada, J. P., & Morales, A. (2021). Influence of implementation fidelity on the effectiveness of a CBT programme targeted emotional problems in childhood. Studies in Educational Evaluation, 68, 100975. https://doi.org/10.1016/j.stueduc.2021.100975

    BACKGROUND
  • Fernandez-Martinez I, Orgiles M, Espada JP, Essau CA, Morales A. Effects as a function of implementation fidelity of a transdiagnostic prevention program in young school-aged children. Eval Program Plann. 2021 Dec;89:102011. doi: 10.1016/j.evalprogplan.2021.102011. Epub 2021 Sep 16.

    PMID: 34562670BACKGROUND
  • 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: 33511861BACKGROUND
  • 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: 33882156BACKGROUND
  • 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: 33918640BACKGROUND

Related Links

MeSH Terms

Conditions

Depressive DisorderDepressionAnxiety DisordersMood DisordersNeurodevelopmental Disorders

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Study Officials

  • Silvia Melero, PhD

    Universidad Miguel Hernández de Elche

    PRINCIPAL INVESTIGATOR
  • Mireia Orgilés, Professor

    Universidad Miguel Hernández de Elche

    STUDY DIRECTOR
  • José Pedro Espada, Professor

    Universidad Miguel Hernández de Elche

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: Study participants who met the inclusion criteria were randomly assigned to the experimental and control groups. The control group did not receive any intervention during the eight-week duration of the program. However, both groups underwent pretest and posttest assessments. Children assigned to the control group will receive the intervention after the 12-month follow-up assessment.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

October 17, 2022

First Posted

October 21, 2022

Study Start

October 1, 2017

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

May 10, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will share

All IPD

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