Super Skills for Life Effectiveness in Clinical Settings

NCT05482724 | Completed DMC

• 1 other identifier: 2018/034
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Depressive Disorder; Depressive Symptoms; Trauma and Stressor Related Disorders; Anxiety Disorders and Symptoms; Anxiety Disorders; Mood Disorders; Emotional Disorder

Outcome Measures

Primary Outcomes (24)

• Change from baseline diagnosis based on DSM-5 criteria to immediately after the intervention

  Measured by Schedule for affective disorders and schizophrenia for schoolage youths-present and lifetime version (K-SADS-PL). The K-SADS-PL is a semi-structured interview for children and adolescents aged 6 to 18 years according to DSM-IV criteria. Additional questions were included in this study to obtain a diagnosis according to the current DSM-5 classification.

  baseline and immediately after the intervention

• Diagnosis based on DSM-5 criteria at 3 months

  Measured by Schedule for affective disorders and schizophrenia for schoolage youths-present and lifetime version (K-SADS-PL). The K-SADS-PL is a semi-structured interview for children and adolescents aged 6 to 18 years according to DSM-IV criteria. Additional questions were included in this study to obtain a diagnosis according to the current DSM-5 classification.

  3 months after the intervention

• Diagnosis based on DSM-5 criteria at 6 months

  Measured by Schedule for affective disorders and schizophrenia for schoolage youths-present and lifetime version (K-SADS-PL). The K-SADS-PL is a semi-structured interview for children and adolescents aged 6 to 18 years according to DSM-IV criteria. Additional questions were included in this study to obtain a diagnosis according to the current DSM-5 classification.

  6 months after the intervention

• Diagnosis based on DSM-5 criteria at 1 year

  Measured by Schedule for affective disorders and schizophrenia for schoolage youths-present and lifetime version (K-SADS-PL). The K-SADS-PL is a semi-structured interview for children and adolescents aged 6 to 18 years according to DSM-IV criteria. Additional questions were included in this study to obtain a diagnosis according to the current DSM-5 classification.

  1 year after the intervention

• Change from baseline depression symptoms to immediately after the intervention

  Measured by Child Depression Inventory (CDI). It assess depressive symptoms experienced in the past two weeks. The CDI provides an overall score (minimum value 0, maximum value 54) and two dimensions values: dysphoria (minimum value 0, maximum value 34), and negative self-esteem (minimum value 0, maximum value 20). Higher scores indicate more severe symptoms.

  baseline and immediately after the intervention

• Depression symptoms at 3 months

  Measured by Child Depression Inventory (CDI). It assess depressive symptoms experienced in the past two weeks. The CDI provides an overall score (minimum value 0, maximum value 54) and two dimensions values: dysphoria (minimum value 0, maximum value 34), and negative self-esteem (minimum value 0, maximum value 20). Higher scores indicate more severe symptoms.

  3 months after the intervention

• Depression symptoms at 6 months

  Measured by Child Depression Inventory (CDI). It assess depressive symptoms experienced in the past two weeks. The CDI provides an overall score (minimum value 0, maximum value 54) and two dimensions values: dysphoria (minimum value 0, maximum value 34), and negative self-esteem (minimum value 0, maximum value 20). Higher scores indicate more severe symptoms.

  6 months after the intervention

• Depression symptoms at 1 year

  Measured by Child Depression Inventory (CDI). It assess depressive symptoms experienced in the past two weeks. The CDI provides an overall score (minimum value 0, maximum value 54) and two dimensions values: dysphoria (minimum value 0, maximum value 34), and negative self-esteem (minimum value 0, maximum value 20). Higher scores indicate more severe symptoms.

  1 year 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). 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). Symptom frequency is recorded on a 3-point Likert scale from 0 (never) to 3 (always). This yields a minimum possible score of 0 and a maximum possible score of 114. Higher scores indicating greater severity of symptoms.

  baseline and immediately 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). 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). Symptom frequency is recorded on a 3-point Likert scale from 0 (never) to 3 (always). This yields a minimum possible score of 0 and a maximum possible score of 114. Higher scores indicating greater severity of symptoms.

  baseline and immediately after the intervention

• Parent-reported anxiety symptoms at 3 months

  Measured by Spence Children's Anxiety Scale Parent Report (SCAS-P). 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). Symptom frequency is recorded on a 3-point Likert scale from 0 (never) to 3 (always). This yields a minimum possible score of 0 and a maximum possible score of 114. Higher scores indicating greater severity of symptoms.

  3 months after the intervention

• Children's reported anxiety symptoms at 3 months

  Measured by Spence Children's Anxiety Scale Child Report (SCAS). 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). Symptom frequency is recorded on a 3-point Likert scale from 0 (never) to 3 (always). This yields a minimum possible score of 0 and a maximum possible score of 114. Higher scores indicating greater severity of symptoms.

  3 months after the intervention

• Parent-reported anxiety symptoms at 6 months

  Measured by Spence Children's Anxiety Scale Parent Report (SCAS-P). 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). Symptom frequency is recorded on a 3-point Likert scale from 0 (never) to 3 (always). This yields a minimum possible score of 0 and a maximum possible score of 114. Higher scores indicating greater severity of symptoms.

  6 months after the intervention

• Children's reported anxiety symptoms at 6 months

  Measured by Spence Children's Anxiety Scale Child Report (SCAS). 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). Symptom frequency is recorded on a 3-point Likert scale from 0 (never) to 3 (always). This yields a minimum possible score of 0 and a maximum possible score of 114. Higher scores indicating greater severity of symptoms.

  6 months after the intervention

• Parent-reported anxiety symptoms at 1 year

  Measured by Spence Children's Anxiety Scale Parent Report (SCAS-P). 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). Symptom frequency is recorded on a 3-point Likert scale from 0 (never) to 3 (always). This yields a minimum possible score of 0 and a maximum possible score of 114. Higher scores indicating greater severity of symptoms.

  1 year after the intervention

• Children's reported anxiety symptoms at 1 year

  Measured by Spence Children's Anxiety Scale Child Report (SCAS). 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). Symptom frequency is recorded on a 3-point Likert scale from 0 (never) to 3 (always). This yields a minimum possible score of 0 and a maximum possible score of 114. Higher scores indicating greater severity of symptoms.

  1 year after the intervention

• Change from baseline parent-reported anxiety-related interference to immediately after the intervention

  Measured by Child Anxiety Life Interference Scale Parent Report (CALIS-P). It assesses life interference and impairment related to anxiety in the child's school, social, and home/family settings. Scores range from a minimum value of 0 to a maximun value of 64. Higher scores indicate larger child anxiety-related interference.

  baseline and immediately after the intervention

• Change from baseline children's reported anxiety-related interference to immediately after the intervention

  Measured by Child Anxiety Life Interference Scale Child Report (CALIS-C). It assesses life interference and impairment related to anxiety in the child's school, social, and home/family settings. Scores range from a minimum value of 0 to a maximun value of 36. Higher scores indicate larger child anxiety-related interference.

  baseline and immediately after the intervention

• Parent-reported anxiety-related interference at 3 months

  Measured by Child Anxiety Life Interference Scale Parent Report (CALIS-P). It assesses life interference and impairment related to anxiety in the child's school, social, and home/family settings. Scores range from a minimum value of 0 to a maximun value of 64. Higher scores indicate larger child anxiety-related interference.

  3 months after the intervention

• Children's reported anxiety-related interference at 3 months

  Measured by Child Anxiety Life Interference Scale Child Report (CALIS-C). It assesses life interference and impairment related to anxiety in the child's school, social, and home/family settings. Scores range from a minimum value of 0 to a maximun value of 36. Higher scores indicate larger child anxiety-related interference.

  3 months after the intervention

• Parent-reported anxiety-related interference at 6 months

  Measured by Child Anxiety Life Interference Scale Parent Report (CALIS-P). It assesses life interference and impairment related to anxiety in the child's school, social, and home/family settings. Scores range from a minimum value of 0 to a maximun value of 64. Higher scores indicate larger child anxiety-related interference.

  6 months after the intervention

• Children's reported anxiety-related interference at 6 months

  Measured by Child Anxiety Life Interference Scale Child Report (CALIS-C). It assesses life interference and impairment related to anxiety in the child's school, social, and home/family settings. Scores range from a minimum value of 0 to a maximun value of 36. Higher scores indicate larger child anxiety-related interference.

  6 months after the intervention

• Parent-reported anxiety-related interference at 1 year

  Measured by Child Anxiety Life Interference Scale Parent Report (CALIS-P). It assesses life interference and impairment related to anxiety in the child's school, social, and home/family settings. Scores range from a minimum value of 0 to a maximun value of 64. Higher scores indicate larger child anxiety-related interference.

  1 year after the intervention

• Children's reported anxiety-related interference at 1 year

  Measured by Child Anxiety Life Interference Scale Child Report (CALIS-C). It assesses life interference and impairment related to anxiety in the child's school, social, and home/family settings. Scores range from a minimum value of 0 to a maximun value of 36. Higher scores indicate larger child anxiety-related interference.

  1 year after the intervention

Secondary Outcomes (17)

• Change from baseline children's reported global mental health symptoms to immediately after the intervention

  baseline and immediately after the intervention

• Change from baseline parent's reported global mental health symptoms to immediately after the intervention

  baseline and immediately after the intervention

• Children's reported global mental health symptoms at 3 months

  3 months after the intervention

• Parent's reported global mental health symptoms at 3 months

  3 months after the intervention

• Children's reported global mental health symptoms at 6 months

  6 months after the intervention

Study Arms (2)

Intervention group

EXPERIMENTAL

Super Skills for Life intervention group

Behavioral: Super Skills for Life

Wait-list group

NO INTERVENTION

Group without any intervention. Participants in the wait-list group received no 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

Super Skills for Life BEHAVIORAL

Structured and manualized intervention with a manual for the therapist and a workbook for the children. Spanish version of Super Skills for Life group program: 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 by a trained clinical psychologist in SSL. Sessions were held after school hours once a week for eight weeks, with each session lasting approximately one hour. The contents of the program were covered through playful activities in groups of 4 to 6 children

Intervention group

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Miguel Hernandez de Elche: lead

Study Sites (1)

Hospital Clínico Universitario Valencia

Valencia, Valencia, 46010, Spain

Location

Related Publications (10)

• 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: 24999861 BACKGROUND

• 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: 31078836 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: 31334667 BACKGROUND

• 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: 31733917 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: 32249749 BACKGROUND

• 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: 33882156 BACKGROUND

• 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: 33918640 BACKGROUND

• 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: 33511861 BACKGROUND

• 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.

  PMID: 27614301 BACKGROUND

• 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: 32325756 BACKGROUND

Related Links

• University of Roehampton research for Super Skills for Life programme

MeSH Terms

Conditions

Depressive Disorder; Depression; Trauma and Stressor Related Disorders; Anxiety Disorders; Mood Disorders

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Sara Diego

  Universidad Miguel Hernandez de Elche

  PRINCIPAL INVESTIGATOR

• Mireia Orgiles

  Universidad Miguel Hernandez de Elche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Model Details: 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.

Study Record Dates

• First Submitted: July 22, 2022
• First Posted: August 1, 2022
• Study Start: May 2, 2018
• Primary Completion: December 14, 2022
• Study Completion: December 14, 2022
• Last Updated: May 10, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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

ES (1)