Clinical trial NCT05589090: Super Skills for Life Effectiveness in the Online Modality
Official title: Adaptación y evaluación Del Programa transdiagnóstico Super Skills for Life Aplicado Online Para niños Con Problemas Interiorizados
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Disorder
Depressive Symptoms
Anxiety Disorders
Anxiety Disorders and Symptoms
Mood Disorders
Child Mental Disorder
Emotional Disorder
Keywords: Super Skills for Life
emotional problems
internalizing problems
children
anxiety
depression
Lead sponsor: Universidad Miguel Hernandez de Elche
Sponsor class: OTHER
Collaborators: name: Ministerio de Economía y Competitividad, Spain
First posted: 2022-10-21
Enrollment: 30
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: PREVENTION

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).

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Change from baseline depression symptoms to immediately after the intervention
timeFrame: 1 year after the intervention
measure: Depression symptoms at 1 year
timeFrame: 1 year after the intervention
measure: Change from baseline parent-reported depression to immediately after the intervention
timeFrame: baseline and immediately after the intervention
measure: Parent-reported depression at 1 year
timeFrame: 1 year after the intervention
measure: Change from baseline children's reported anxiety symptoms to immediately after the intervention
timeFrame: baseline and immediately after the intervention
measure: Change from baseline parent-reported anxiety symptoms to immediately after the intervention
timeFrame: baseline and immediately after the intervention
measure: Children's reported anxiety symptoms at 1 year
timeFrame: 1 year after the intervention
measure: Parent-reported anxiety at 1 year
timeFrame: 1 year after the intervention
measure: Change from baseline children's reported psychological adjustment to immediately after the intervention
timeFrame: baseline and immediately after the intervention
measure: Change from baseline parent-reported psychological adjustment to immediately after the intervention
timeFrame: baseline and immediately after the intervention
measure: Children's reported psychological adjustment at 1 year
timeFrame: 1 year after the intervention
measure: Parent-reported psychological adjustment at 1 year
timeFrame: 1 year after the intervention
Secondary outcomes:
measure: Change from baseline self-concept to immediately after the intervention
timeFrame: baseline and immediately after the intervention
measure: Children's self-concept at 1 year
timeFrame: 1 year after the intervention
measure: Change from baseline social worries to immediately after the intervention
timeFrame: baseline and immediately after the intervention
measure: Children's social worries at 1 year
timeFrame: 1 year after the intervention
Other outcomes:
Locations:
city: Elche
country: Spain
facility: Universidad Miguel Hernández de Elche
state: Alicante
Study officials:
affiliation: Universidad Miguel Hernández de Elche
name: Silvia Melero, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad Miguel Hernández de Elche
name: Mireia Orgilés, Professor
role: STUDY_DIRECTOR
affiliation: Universidad Miguel Hernández de Elche
name: José Pedro Espada, Professor
role: STUDY_DIRECTOR
References:
citation: Essau, C. A., & Ollendick, T. H. (2013). The Super Skills for Life Programme. London, Reino Unido: University of Roehampton
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.
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.
citation: 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
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.
citation: 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.
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.
citation: 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
citation: 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
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.
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.
citation: 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
citation: 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
citation: 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
citation: 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.
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.
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.
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.