Depressive DisorderNCT05589090
Super Skills for Life Effectiveness in the Online Modality
A study testing Super Skills for Life program in people with Depressive Disorder and Depressive Symptoms, run by Universidad Miguel Hernandez de Elche at 1 site in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Depressive Disorder, Depressive Symptoms, Anxiety Disorders
- What is being tested?
- Super Skills for Life program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2017to 1 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- Had a psychiatric diagnosis already established
- Presenting a severe developmental disorder (intellectual disability, autism spectrum disorder, etc).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adaptación y evaluación Del Programa transdiagnóstico Super Skills for Life Aplicado Online Para niños Con Problemas Interiorizados
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).
Read the 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.
- Conditions
- Depressive Disorder, Depressive Symptoms, Anxiety Disorders, Anxiety Disorders and Symptoms, Mood Disorders, Child Mental Disorder
- Being tested
- Super Skills for Life program
- Keywords
- Super Skills for Life, emotional problems, internalizing problems, children, anxiety, depression
- Medical subject headings
- Depressive Disorder, Depression, Anxiety Disorders, Mood Disorders, Neurodevelopmental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Super Skills for Life programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Super Skills for Life intervention Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 year after the intervention
Secondary outcomes (4)
Change from baseline self-concept to immediately after the intervention
Measured by the Self-Concept Form 5 (AF-5). It measures global satisfaction with self-concept (minimum value 0 and maximum value 120) and five dimensions (minimum value 0 and maximum value 24): Social (performance in social relationships); Academic/Professional (student/worker role); Emotional (perception of emotional state in general and in specific situations); Family (participation and integration into the family unit); and Physical self-concept (appearance and physical condition). Higher scores indicate greater satisfaction with self-image.
Measured: baseline and immediately after the intervention
Children's self-concept at 1 year
Measured by the Self-Concept Form 5 (AF-5). It measures global satisfaction with self-concept (minimum value 0 and maximum value 120) and five dimensions (minimum value 0 and maximum value 24): Social (performance in social relationships); Academic/Professional (student/worker role); Emotional (perception of emotional state in general and in specific situations); Family (participation and integration into the family unit); and Physical self-concept (appearance and physical condition). Higher scores indicate greater satisfaction with self-image.
Measured: 1 year after the intervention
Change from baseline social worries to immediately after the intervention
Measured by the Social Worries Questionnaire for pupils (SWQ-PU). It evaluates children's worries in different social situations. In general, the higher the score, the more severe the symptomatology.
Measured: baseline and immediately after the intervention
Children's social worries at 1 year
Measured by the Social Worries Questionnaire for pupils (SWQ-PU). It evaluates children's worries in different social situations. In general, the higher the score, the more severe the symptomatology.
Measured: 1 year after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2022
- Study start1 Oct 2017
- Primary completion1 Dec 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Miguel Hernandez de Elche
- Sponsor type
- University, hospital or other
- Collaborators
- Ministerio de Economía y Competitividad, Spain
- Responsible party
- Principal investigator, Mireia Orgilés Amorós, Universidad Miguel Hernandez de Elche
- Investigators
- Silvia Melero, PhD, Principal investigator, Universidad Miguel Hernández de Elche.Mireia Orgilés, Professor, Study director, Universidad Miguel Hernández de Elche.José Pedro Espada, Professor, Study director, Universidad Miguel Hernández de Elche.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05589090
- Sponsor's protocol ID
- DPS.MO.01.17
- Status last verified
- May 2023
- First submitted
- 17 Oct 2022
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD
Publications
Essau, C. A., & Ollendick, T. H. (2013). The Super Skills for Life Programme. London, Reino Unido: University of Roehampton
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.
PubMed 24999861Essau 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.
PubMed 31078836Fernández-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
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.
PubMed 31334667Fernandez-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.
PubMed 31292045Fernandez-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.
PubMed 31733917Diego-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
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
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.
PubMed 32249749Orgiles 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.
PubMed 32325756Orgilés, 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
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
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
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.
PubMed 34562670
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptación y evaluación Del Programa transdiagnóstico Super Skills for Life Aplicado Online Para niños Con Problemas Interiorizados
- ClinicalTrials.gov ID
- NCT05589090
- Acronym / sponsor ID
- DPS.MO.01.17
- Conditions
- Depressive Disorder, Depressive Symptoms, Anxiety Disorders, Anxiety Disorders and Symptoms, Mood Disorders, Child Mental Disorder
- Keywords
- Super Skills for Life, emotional problems, internalizing problems, children, anxiety, depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universidad Miguel Hernandez de ElcheUniversity, hospital or other
- Collaborators
- Ministerio de Economía y Competitividad, Spain
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 21 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Super Skills for Life programSuper Skills for Life intervention |
| 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. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Had a psychiatric diagnosis already established
- Presenting a severe developmental disorder (intellectual disability, autism spectrum disorder, etc).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Super Skills for Life programChildren 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. | Behavioural | Intervention group |
Primary outcome
Change from baseline depression symptoms to immediately after the intervention
Time frame: 1 year 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.
Depression symptoms at 1 year
Time frame: 1 year 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.
Change from baseline parent-reported depression to immediately after the intervention
Time frame: baseline and 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.
Parent-reported depression at 1 year
Time frame: 1 year 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.
Change from baseline children's reported anxiety symptoms to immediately after the intervention
Time frame: baseline and 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
Change from baseline parent-reported anxiety symptoms to immediately after the intervention
Time frame: baseline and 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.
Children's reported anxiety symptoms at 1 year
Time frame: 1 year 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
Parent-reported anxiety at 1 year
Time frame: 1 year 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.
Change from baseline children's reported psychological adjustment to immediately after the intervention
Time frame: baseline and 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.
Change from baseline parent-reported psychological adjustment to immediately after the intervention
Time frame: baseline and 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.
Children's reported psychological adjustment at 1 year
Time frame: 1 year 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.
Parent-reported psychological adjustment at 1 year
Time frame: 1 year 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.
4 secondary outcomes
Change from baseline self-concept to immediately after the intervention
Time frame: baseline and immediately after the intervention
Children's self-concept at 1 year
Time frame: 1 year after the intervention
Change from baseline social worries to immediately after the intervention
Time frame: baseline and immediately after the intervention
Children's social worries at 1 year
Time frame: 1 year after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- BackgroundEssau, C. A., & Ollendick, T. H. (2013). The Super Skills for Life Programme. London, Reino Unido: University of Roehampton
- Background: PubMed 24999861Essau 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.
- Background: PubMed 31078836Essau 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.
- BackgroundFernández-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: PubMed 31334667Orgiles 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.
- Background: PubMed 31292045Fernandez-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.
- Background: PubMed 31733917Fernandez-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.
- BackgroundDiego-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
- BackgroundMelero, 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: PubMed 32249749Fernandez-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.
- Background: PubMed 32325756Orgiles 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.
- BackgroundOrgilés, 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
- Description University of Roehampton research for Super Skills for Life programLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Silvia Melero, PhD principal investigator
Universidad Miguel Hernández de Elche.
Mireia Orgilés, Professor study director
Universidad Miguel Hernández de Elche.
José Pedro Espada, Professor study director
Universidad Miguel Hernández de Elche.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Super Skills for Life program in people with Depressive Disorder and Depressive Symptoms, run by Universidad Miguel Hernandez de Elche at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline depression symptoms to immediately after the intervention (time frame: 1 year after the intervention). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05589090, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023.