Clinical trial NCT05574491: Effectiveness of Traditional and Computerized Versions of Super Skills for Life in Children
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Depressive Disorder
Depressive Symptoms
Anxiety Disorders
Anxiety Disorders and Symptoms
Mood Disorders
Emotional Disorder
Lead sponsor: Universidad Miguel Hernandez de Elche
Sponsor class: OTHER
First posted: 2022-10-10
Enrollment: 105
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Baseline children's reported anxiety symptoms
timeFrame: Baseline
measure: Children's reported anxiety symptoms immediately after the intervention
timeFrame: Immediately after the intervention
measure: Children's reported anxiety symptoms at 6 months
timeFrame: 6 months after the intervention
measure: Children's reported anxiety symptoms at 12 months
timeFrame: 12 months after the intervention
measure: Baseline parent-reported anxiety symptoms
timeFrame: Baseline
measure: Parent-reported anxiety symptoms immediately after the intervention
timeFrame: Immediately after the intervention
measure: Parent-reported anxiety symptoms immediately at 6 months
timeFrame: 6 months after the intervention
measure: Parent-reported anxiety symptoms immediately at 12 months
timeFrame: 12 months after the intervention
measure: Baseline children's reported depressive symptoms
timeFrame: Baseline
measure: Children's reported depressive symptoms immediately after the intervention
timeFrame: Immediately after the intervention
measure: Children's reported depressive symptoms at 6 months
timeFrame: 6 months after the intervention
measure: Children's reported depressive symptoms at 12 months
timeFrame: 12 months after the intervention
measure: Baseline parent-reported depressive symptoms
timeFrame: Baseline
measure: Parent-reported depressive symptoms immediately after the intervention
timeFrame: Immediately after the intervention
measure: Parent-reported depressive symptoms immediately at 6 months
timeFrame: 6 months after the intervention
measure: Parent-reported depressive symptoms immediately at 12 months
timeFrame: 12 months after the intervention
Secondary outcomes:
measure: Baseline children's anxiety-related interference
timeFrame: Baseline
measure: Children's anxiety-related interference immediately after the intervention
timeFrame: Immediately after the intervention
measure: Children's anxiety-related interference at 6 months
timeFrame: 6 months after the intervention
measure: Children's anxiety-related interference at 12 months
timeFrame: 12 months after the intervention
measure: Baseline parent-reported anxiety-related interference
timeFrame: Baseline
measure: Parent-reported anxiety-related interference immediately after the intervention
timeFrame: Immediately after the intervention
measure: Parent-reported anxiety-related interference at 6 months
timeFrame: 6 months after the intervention
measure: Parent-reported anxiety-related interference at 12 months
timeFrame: 12 months after the intervention
measure: Baseline self-esteem
timeFrame: Baseline
measure: Self-esteem immediately after the intervention
timeFrame: Immediately after the intervention
measure: Self-esteem at 6 months
timeFrame: 6 months after the intervention
measure: Self-esteem at 12 months
timeFrame: 12 months after the intervention
measure: Baseline social skills
timeFrame: Baseline
measure: Social skills immediately after the intervention
timeFrame: Immediately after the intervention
measure: Social skills at 6 months
timeFrame: 6 months after the intervention
measure: Social skills at 12 months
timeFrame: 12 months after the intervention
measure: Baseline social worries
timeFrame: Baseline
measure: Social worries immediately after the intervention
timeFrame: Immediately after the intervention
measure: Social worries at 6 months
timeFrame: 6 months after the intervention
measure: Social worries at 12 months
timeFrame: 12 months after the intervention
measure: Baseline cognitive emotion regulation strategies
timeFrame: Baseline
measure: Cognitive emotion regulation strategies immediately after the intervention
timeFrame: Immediately after the intervention
measure: Cognitive emotion regulation strategies at 6 months
timeFrame: 6 months after the intervention
measure: Cognitive emotion regulation strategies at 12 months
timeFrame: 12 months after the intervention
measure: Baseline parental depression, anxiety and stress symptoms
timeFrame: Baseline
measure: Baseline parental depression, anxiety and stress symptoms
timeFrame: Immediately after the intervention
measure: Baseline parental depression, anxiety and stress symptoms
timeFrame: 6 months after the intervention
measure: Baseline parental depression, anxiety and stress symptoms
timeFrame: 12 months after the intervention
Other outcomes:
Locations:
city: Elche
country: Spain
facility: Department of Health Psychology. Miguel Hernandez University of Elche
state: Alicante
Study officials:
affiliation: Miguel Hernandez University of Elche
name: Mireia Orgilés Amorós
role: PRINCIPAL_INVESTIGATOR
References:
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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: 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, 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: 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: 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: 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.
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: 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.
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.