Clinical trial NCT05482724: Super Skills for Life Effectiveness in Clinical Settings
Official title: Treatment of Emotional Disorders in Spanish Children: Efficacy of Super Skills for Life Transdiagnostic Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Disorder
Depressive Symptoms
Trauma and Stressor Related Disorders
Anxiety Disorders and Symptoms
Anxiety Disorders
Mood Disorders
Emotional Disorder
Lead sponsor: Universidad Miguel Hernandez de Elche
Sponsor class: OTHER
First posted: 2022-08-01
Enrollment: 74
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 were randomly allocated to the conditions of the intervention group and the wait-list control group. Participants in the wait-list group (WLC) received no phycological (public or private) intervention during the eight-week duration of the program. Children and parents in both groups would 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 short- and long-term effects of SSL on internalizing and externalizing symptoms in Spanish children attending the Child and Adolescent Mental Health Services.

Detailed description: To validate eligibility children and their parents will complete several psychometrically robust and developmentally appropriate measures. Participants meeting inclusion criteria will be randomly allocated to the conditions of the intervention group and the wait-list control group.

Parents and children from both groups will complete the same measures at baseline and post-treatment.

Parents and children from SSL will also complete these measures at 3 months follow-up, 6 months follow-up and 12 months follow-up.

The investigators will assess the benefits from pre-test to post-test in children participating in SSL compared to those in a wait-list control group on DSM-5 diagnostic remission, anxiety symptoms, anxiety impairment, depressive symptoms, self-esteem, behavioral problems, hyperactivity/inattention, peer relationship problems, and prosocial behavior.

The investigators will also assess these variables in the intervention group at 3 months, 6 months, and 12 months follow-up.

Ultimately, the goal of the study is to explore whether SSL can be a cost-effective psychological intervention for emotional disorders in the Spanish National Health System.

Eligibility criteria: Inclusion Criteria:

* Children aged 8 - 12.
* Primary diagnosis of an anxiety disorder, a depressive disorder, and/or trauma- or stress-related disorder with anxiety and/or depressive symptoms.
* Speaking, reading, writing and understanding Spanish.
* Caregivers agree to attend all sessions and to receive feedback and suggestions.

Exclusion Criteria:

* Intellectual disability, behavioral symptoms, or autism spectrum symptoms whose severity precluded continued treatment.
* The child is at the same time in psychological treatment.
* The child is not on a stable dose of medication for at least 1 month prior to baseline assessment.

Primary outcomes:
measure: Change from baseline diagnosis based on DSM-5 criteria to immediately after the intervention
timeFrame: baseline and immediately after the intervention
measure: Diagnosis based on DSM-5 criteria at 3 months
timeFrame: 3 months after the intervention
measure: Diagnosis based on DSM-5 criteria at 6 months
timeFrame: 6 months after the intervention
measure: Diagnosis based on DSM-5 criteria at 1 year
timeFrame: 1 year after the intervention
measure: Change from baseline depression symptoms to immediately after the intervention
timeFrame: baseline and immediately after the intervention
measure: Depression symptoms at 3 months
timeFrame: 3 months after the intervention
measure: Depression symptoms at 6 months
timeFrame: 6 months after the intervention
measure: Depression symptoms at 1 year
timeFrame: 1 year after the intervention
measure: Change from baseline parent-reported anxiety symptoms to immediately after the intervention
timeFrame: baseline and immediately 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: Parent-reported anxiety symptoms at 3 months
timeFrame: 3 months after the intervention
measure: Children's reported anxiety symptoms at 3 months
timeFrame: 3 months after the intervention
measure: Parent-reported anxiety symptoms at 6 months
timeFrame: 6 months after the intervention
measure: Children's reported anxiety symptoms at 6 months
timeFrame: 6 months after the intervention
measure: Parent-reported anxiety symptoms at 1 year
timeFrame: 1 year after the intervention
measure: Children's reported anxiety symptoms at 1 year
timeFrame: 1 year after the intervention
measure: Change from baseline parent-reported anxiety-related interference to immediately after the intervention
timeFrame: baseline and immediately after the intervention
measure: Change from baseline children's reported anxiety-related interference to immediately after the intervention
timeFrame: baseline and immediately after the intervention
measure: Parent-reported anxiety-related interference at 3 months
timeFrame: 3 months after the intervention
measure: Children's reported anxiety-related interference at 3 months
timeFrame: 3 months after the intervention
measure: Parent-reported anxiety-related interference at 6 months
timeFrame: 6 months after the intervention
measure: Children's reported anxiety-related interference at 6 months
timeFrame: 6 months after the intervention
measure: Parent-reported anxiety-related interference at 1 year
timeFrame: 1 year after the intervention
measure: Children's reported anxiety-related interference at 1 year
timeFrame: 1 year after the intervention
Secondary outcomes:
measure: Change from baseline children's reported global mental health symptoms to immediately after the intervention
timeFrame: baseline and immediately after the intervention
measure: Change from baseline parent's reported global mental health symptoms to immediately after the intervention
timeFrame: baseline and immediately after the intervention
measure: Children's reported global mental health symptoms at 3 months
timeFrame: 3 months after the intervention
measure: Parent's reported global mental health symptoms at 3 months
timeFrame: 3 months after the intervention
measure: Children's reported global mental health symptoms at 6 months
timeFrame: 6 months after the intervention
measure: Parent's reported global mental health symptoms at 6 months
timeFrame: 6 months after the intervention
measure: Children's reported global mental health symptoms at 1 year
timeFrame: 1 year after the intervention
measure: Parent's reported global mental health symptoms at 1 year
timeFrame: 1 year after the intervention
measure: Change from baseline self-esteem to immediately after the intervention
timeFrame: baseline and immediately after the intervention
measure: Self-esteem at 3 months
timeFrame: 3 months after the intervention
measure: Self-esteem at 6 months
timeFrame: 6 months after the intervention
measure: Self-esteem at 1 year
timeFrame: 1 year after the intervention
measure: Perfectionism
timeFrame: pre-intervention
measure: Changes from baseline health-related quality of life to immediately after the intervention
timeFrame: baseline and immediately after the intervention
measure: Health-related quality of life at 3 months
timeFrame: 3 months after the intervention
measure: Health-related quality of life at 6 months
timeFrame: 6 months after the intervention
measure: Health-related quality of life at 1 year
timeFrame: 1 year after the intervention
Other outcomes:
Locations:
city: Valence
country: Spain
facility: Hospital Clínico Universitario Valencia
state: Valencia
Study officials:
affiliation: Universidad Miguel Hernandez de Elche
name: Sara Diego
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad Miguel Hernandez de Elche
name: Mireia Orgiles
role: STUDY_DIRECTOR
References:
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: 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: 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, 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.
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.