Depressive DisorderNCT05574491
Effectiveness of Traditional and Computerized Versions of Super Skills for Life in Children
A study testing Super Skills for Life: traditional version and Super Skills for Life: computerized version in people with Depressive Disorder and Depressive Symptoms, run by Universidad Miguel Hernandez de Elche at 1 site in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Depressive Disorder, Depressive Symptoms, Anxiety Disorders
- What is being tested?
- Super Skills for Life: traditional version and Super Skills for Life: computerized version
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteSpain
- Study dates
- 7 Feb 2023to 31 Dec 2024
- 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
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Department of Health Psychology. Miguel Hernandez University of Elche
Elche, Alicante, 03202
About this study
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
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.
Read the 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.
- Conditions
- Depressive Disorder, Depressive Symptoms, Anxiety Disorders, Anxiety Disorders and Symptoms, Mood Disorders, Emotional Disorder
- Being tested
- Super Skills for Life: traditional version, Super Skills for Life: computerized version
- Medical subject headings
- Depressive Disorder, Depression, Anxiety Disorders, Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Super Skills for Life: traditional versionBehavioural
Structured and manualized intervention with a manual for the therapist and a workbook for the children.
The intervention will be administered by trained clinical psychologists in SSL. Sessions will be held once a week for eight weeks, with each session lasting approximately forty five minutes.
The program includes emotional education, social skills training, cognitive restructuring, relaxation techniques, self-observation, problem solving and behavioural activation. These contents are learned through playful exercises, activities, readings, and role-playing.
Both modalities of intervention will be in-person.
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.
Super Skills for Life: computerized versionBehavioural
Structured and manualized intervention with a manual for the therapist and multimedia material for the children.
| Study group | Role | What they receive |
|---|---|---|
| Super Skills for Life intervention group: traditional version | Experimental | The Super Skills for Life program will be administered following the manual of the intervention by a trained therapist, as described in the section of intervention/treatment. Receives: Behavioral: Super Skills for Life: traditional version |
| Super Skills for Life intervention group: computerized version | Experimental | The Super Skills for Life program will be administered in-person as well by a trained therapist, as described in the section of intervention treatment.
The therapist will use the multimedia presentation of the program's contents as a tool for the better development of the sessions. The digital version of the program consists of an animation whose characters narrate examples that help the children better understand the contents. The therapist will have a password assigned to each child, and it will be the therapist who will guide the sessions and select the contents of the digital presentation that correspond to each session. The web address to access the programme is https://www.superskillsonline.com/. Receives: Behavioral: Super Skills for Life: computerized version |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline children's reported anxiety symptoms
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.
Measured: Baseline
Children's reported anxiety symptoms 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.
Measured: Immediately 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.
Measured: 6 months after the intervention
Children's reported anxiety symptoms at 12 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.
Measured: 12 months after the intervention
Baseline parent-reported anxiety symptoms
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.
Measured: Baseline
Parent-reported anxiety symptoms 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.
Measured: Immediately after the intervention
Parent-reported anxiety symptoms immediately 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.
Measured: 6 months after the intervention
Parent-reported anxiety symptoms immediately at 12 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.
Measured: 12 months after the intervention
Baseline children's reported depressive symptoms
Measured by Mood and Feelings Questionnaire - Short Version (MFQS). It assess depressive symptoms experienced in the past two weeks. The MFQS provides an overall score (minimum value 0, maximum value 26). Higher scores indicate more severe symptoms.
Measured: Baseline
Children's reported depressive symptoms immediately after the intervention
Measured by Mood and Feelings Questionnaire - Short Version (MFQS). It assess depressive symptoms experienced in the past two weeks. The MFQS provides an overall score (minimum value 0, maximum value 26). Higher scores indicate more severe symptoms.
Measured: Immediately after the intervention
Children's reported depressive symptoms at 6 months
Measured by Mood and Feelings Questionnaire - Short Version (MFQS). It assess depressive symptoms experienced in the past two weeks. The MFQS provides an overall score (minimum value 0, maximum value 26). Higher scores indicate more severe symptoms.
Measured: 6 months after the intervention
Children's reported depressive symptoms at 12 months
Measured by Mood and Feelings Questionnaire - Short Version (MFQS). It assess depressive symptoms experienced in the past two weeks. The MFQS provides an overall score (minimum value 0, maximum value 26). Higher scores indicate more severe symptoms.
Measured: 12 months after the intervention
Baseline parent-reported depressive symptoms
Measured by Mood and Feelings Questionnaire Parent-Report (MFQ-P). It assess depressive symptoms experienced in the past two weeks. The MFQS provides an overall score (minimum value 0, maximum value 68). Higher scores indicate more severe symptoms.
Measured: Baseline
Parent-reported depressive symptoms immediately after the intervention
Measured by Mood and Feelings Questionnaire Parent-Report (MFQ-P). It assess depressive symptoms experienced in the past two weeks. The MFQS provides an overall score (minimum value 0, maximum value 68). Higher scores indicate more severe symptoms.
Measured: Immediately after the intervention
Parent-reported depressive symptoms immediately at 6 months
Measured by Mood and Feelings Questionnaire Parent-Report (MFQ-P). It assess depressive symptoms experienced in the past two weeks. The MFQS provides an overall score (minimum value 0, maximum value 68). Higher scores indicate more severe symptoms.
Measured: 6 months after the intervention
Parent-reported depressive symptoms immediately at 12 months
Measured by Mood and Feelings Questionnaire Parent-Report (MFQ-P). It assess depressive symptoms experienced in the past two weeks. The MFQS provides an overall score (minimum value 0, maximum value 68). Higher scores indicate more severe symptoms.
Measured: 12 months after the intervention
Secondary outcomes (28)
Baseline children's anxiety-related interference
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.
Measured: Baseline
Children's anxiety-related interference 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.
Measured: Immediately after the intervention
Children's 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.
Measured: 6 months after the intervention
Children's anxiety-related interference at 12 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.
Measured: 12 months after the intervention
Baseline parent-reported anxiety-related interference
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.
Measured: Baseline
Parent-reported anxiety-related interference 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.
Measured: Immediately 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.
Measured: 6 months after the intervention
Parent-reported anxiety-related interference at 12 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.
Measured: 12 months after the intervention
Baseline self-esteem
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
Self-esteem immediately after the intervention
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: Immediately after the intervention
Self-esteem at 6 months
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: 6 months after the intervention
Self-esteem at 12 months
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: 12 months after the intervention
Baseline social skills
Social Skills Questionnaire (SSQ). It measures children's social functioning, as reflected by specific behavioural responses during interaction with another person. The scale consists of 30 items rated 0 to 2 points. Minimum value 0 and maximum value 60. Higher scores indicate higher social skills.
Measured: Baseline
Social skills immediately after the intervention
Social Skills Questionnaire (SSQ). It measures children's social functioning, as reflected by specific behavioural responses during interaction with another person. The scale consists of 30 items rated 0 to 2 points. Minimum value 0 and maximum value 60. Higher scores indicate higher social skills.
Measured: Immediately after the intervention
Social skills at 6 months
Social Skills Questionnaire (SSQ). It measures children's social functioning, as reflected by specific behavioural responses during interaction with another person. The scale consists of 30 items rated 0 to 2 points. Minimum value 0 and maximum value 60. Higher scores indicate higher social skills.
Measured: 6 months after the intervention
Social skills at 12 months
Social Skills Questionnaire (SSQ). It measures children's social functioning, as reflected by specific behavioural responses during interaction with another person. The scale consists of 30 items rated 0 to 2 points. Minimum value 0 and maximum value 60. Higher scores indicate higher social skills.
Measured: 12 months after the intervention
Baseline social worries
Social Worries Questionnaire (SSW). It measures children's social worries, in terms of anxiety about and avoidance of specific social situations in which social evaluation or scrutiny by others is likely to occur. The scale consists of 12 items rated 0 to 2 points. Minimum value 0 and maximum value 24. Higher scores indicate higher social worries.
Measured: Baseline
Social worries immediately after the intervention
Social Worries Questionnaire (SSW). It measures children's social worries, in terms of anxiety about and avoidance of specific social situations in which social evaluation or scrutiny by others is likely to occur. The scale consists of 12 items rated 0 to 2 points. Minimum value 0 and maximum value 24. Higher scores indicate higher social worries.
Measured: Immediately after the intervention
Social worries at 6 months
Social Worries Questionnaire (SSW). It measures children's social worries, in terms of anxiety about and avoidance of specific social situations in which social evaluation or scrutiny by others is likely to occur. The scale consists of 12 items rated 0 to 2 points. Minimum value 0 and maximum value 24. Higher scores indicate higher social worries.
Measured: 6 months after the intervention
Social worries at 12 months
Social Worries Questionnaire (SSW). It measures children's social worries, in terms of anxiety about and avoidance of specific social situations in which social evaluation or scrutiny by others is likely to occur. The scale consists of 12 items rated 0 to 2 points. Minimum value 0 and maximum value 24. Higher scores indicate higher social worries.
Measured: 12 months after the intervention
Baseline cognitive emotion regulation strategies
Measured by the Cognitive Emotion Regulation Questionnaire (CERQ-k). CERQ-k consists of 36 items that measure nine cognitive coping strategies. Each subscale represents one cognitive coping strategy: Self-blame, Other blame, Acceptance, Planning, Positive refocusing, Rumination or focus on thought, Positive reappraisal, Putting into perspective, and Catastrophizing. The response format of the items is a five point scale from (almost) never to (almost) always. Each item is rated 1 to 5 points. Minimum value 36 and maximum value 180.
Measured: Baseline
Cognitive emotion regulation strategies immediately after the intervention
Measured by the Cognitive Emotion Regulation Questionnaire children self-report (CERQ-k). CERQ-k consists of 36 items that measure nine cognitive coping strategies. Each subscale represents one cognitive coping strategy: Self-blame, Other blame, Acceptance, Planning, Positive refocusing, Rumination or focus on thought, Positive reappraisal, Putting into perspective, and Catastrophizing. The response format of the items is a five point scale from (almost) never to (almost) always. Each item is rated 1 to 5 points. Minimum value 36 and maximum value 180.
Measured: Immediately after the intervention
Cognitive emotion regulation strategies at 6 months
Measured by the Cognitive Emotion Regulation Questionnaire children self-report (CERQ-k). CERQ-k consists of 36 items that measure nine cognitive coping strategies. Each subscale represents one cognitive coping strategy: Self-blame, Other blame, Acceptance, Planning, Positive refocusing, Rumination or focus on thought, Positive reappraisal, Putting into perspective, and Catastrophizing. The response format of the items is a five point scale from (almost) never to (almost) always. Each item is rated 1 to 5 points. Minimum value 36 and maximum value 180.
Measured: 6 months after the intervention
Cognitive emotion regulation strategies at 12 months
Measured by the Cognitive Emotion Regulation Questionnaire children self-report (CERQ-k). CERQ-k consists of 36 items that measure nine cognitive coping strategies. Each subscale represents one cognitive coping strategy: Self-blame, Other blame, Acceptance, Planning, Positive refocusing, Rumination or focus on thought, Positive reappraisal, Putting into perspective, and Catastrophizing. The response format of the items is a five point scale from (almost) never to (almost) always. Each item is rated 1 to 5 points. Minimum value 36 and maximum value 180.
Measured: 12 months after the intervention
Baseline parental depression, anxiety and stress symptoms
Measured by the Depression Anxiety Stress Scales - short version (DASS-21). It contains a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress.
Each of the three DASS-21 scales contains 7 items, divided into subscales with similar content. The depression scale assesses dysphoria, hopelessness, devaluation of life, self-deprecation, lack of interest / involvement, anhedonia and inertia. The anxiety scale assesses autonomic arousal, skeletal muscle effects, situational anxiety, and subjective experience of anxious affect. The stress scale is sensitive to levels of chronic nonspecific arousal. It assesses difficulty relaxing, nervous arousal, and being easily upset / agitated, irritable / over-reactive and impatient. Scores for depression, anxiety and stress are calculated by summing the scores for the relevant items.
Measured: Baseline
Baseline parental depression, anxiety and stress symptoms
Measured by the Depression Anxiety Stress Scales - short version (DASS-21). It contains a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress.
Each of the three DASS-21 scales contains 7 items, divided into subscales with similar content. The depression scale assesses dysphoria, hopelessness, devaluation of life, self-deprecation, lack of interest / involvement, anhedonia and inertia. The anxiety scale assesses autonomic arousal, skeletal muscle effects, situational anxiety, and subjective experience of anxious affect. The stress scale is sensitive to levels of chronic nonspecific arousal. It assesses difficulty relaxing, nervous arousal, and being easily upset / agitated, irritable / over-reactive and impatient. Scores for depression, anxiety and stress are calculated by summing the scores for the relevant items.
Measured: Immediately after the intervention
Baseline parental depression, anxiety and stress symptoms
Measured by the Depression Anxiety Stress Scales - short version (DASS-21). It contains a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress.
Each of the three DASS-21 scales contains 7 items, divided into subscales with similar content. The depression scale assesses dysphoria, hopelessness, devaluation of life, self-deprecation, lack of interest / involvement, anhedonia and inertia. The anxiety scale assesses autonomic arousal, skeletal muscle effects, situational anxiety, and subjective experience of anxious affect. The stress scale is sensitive to levels of chronic nonspecific arousal. It assesses difficulty relaxing, nervous arousal, and being easily upset / agitated, irritable / over-reactive and impatient. Scores for depression, anxiety and stress are calculated by summing the scores for the relevant items.
Measured: 6 months after the intervention
Baseline parental depression, anxiety and stress symptoms
Measured by the Depression Anxiety Stress Scales - short version (DASS-21). It contains a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress.
Each of the three DASS-21 scales contains 7 items, divided into subscales with similar content. The depression scale assesses dysphoria, hopelessness, devaluation of life, self-deprecation, lack of interest / involvement, anhedonia and inertia. The anxiety scale assesses autonomic arousal, skeletal muscle effects, situational anxiety, and subjective experience of anxious affect. The stress scale is sensitive to levels of chronic nonspecific arousal. It assesses difficulty relaxing, nervous arousal, and being easily upset / agitated, irritable / over-reactive and impatient. Scores for depression, anxiety and stress are calculated by summing the scores for the relevant items.
Measured: 12 months 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 posted10 Oct 2022
- Study start7 Feb 2023
- Primary completion31 Dec 2023
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Miguel Hernandez de Elche
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mireia Orgilés Amorós, Universidad Miguel Hernandez de Elche
- Investigators
- Mireia Orgilés Amorós, Principal investigator, Miguel Hernandez University of Elche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05574491
- Sponsor's protocol ID
- 220118115011
- Status last verified
- Jan 2024
- First submitted
- 6 Oct 2022
- Last updated
- 1 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD
Publications
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 31078836Orgiles 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, 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 31733917Melero 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.
PubMed 33882156Fernandez-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 32249749Melero 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.
PubMed 33918640Melero 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.
PubMed 33511861Escribano 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.
PubMed 27614301Orgiles 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 32325756
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05574491
- Acronym / sponsor ID
- 220118115011
- Conditions
- Depressive Disorder, Depressive Symptoms, Anxiety Disorders, Anxiety Disorders and Symptoms, Mood Disorders, Emotional Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Universidad Miguel Hernandez de ElcheUniversity, hospital or other
- Study start
- 7 Feb 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 10 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Super Skills for Life intervention group: traditional version | Experimental | Behavioral: Super Skills for Life: traditional versionThe Super Skills for Life program will be administered following the manual of the intervention by a trained therapist, as described in the section of intervention/treatment. |
| Super Skills for Life intervention group: computerized version | Experimental | Behavioral: Super Skills for Life: computerized versionThe Super Skills for Life program will be administered in-person as well by a trained therapist, as described in the section of intervention treatment. The therapist will use the multimedia presentation of the program's contents as a tool for the better development of the sessions. The digital version of the program consists of an animation whose characters narrate examples that help the children better understand the contents. The therapist will have a password assigned to each child, and it will be the therapist who will guide the sessions and select the contents of the digital presentation that correspond to each session. The web address to access the programme is https://www.superskillsonline.com/. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
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: traditional versionStructured and manualized intervention with a manual for the therapist and a workbook for the children. The intervention will be administered by trained clinical psychologists in SSL. Sessions will be held once a week for eight weeks, with each session lasting approximately forty five minutes. The program includes emotional education, social skills training, cognitive restructuring, relaxation techniques, self-observation, problem solving and behavioural activation. These contents are learned through playful exercises, activities, readings, and role-playing. Both modalities of intervention will be in-person. 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. | Behavioural | Super Skills for Life intervention group: traditional version |
| Super Skills for Life: computerized versionStructured and manualized intervention with a manual for the therapist and multimedia material for the children. | Behavioural | Super Skills for Life intervention group: computerized version |
Primary outcome
Baseline children's reported anxiety symptoms
Time frame: Baseline
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.
Children's reported anxiety symptoms immediately after the intervention
Time frame: 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.
Children's reported anxiety symptoms at 6 months
Time frame: 6 months 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.
Children's reported anxiety symptoms at 12 months
Time frame: 12 months 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 parent-reported anxiety symptoms
Time frame: Baseline
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.
Parent-reported anxiety symptoms immediately after the intervention
Time frame: 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.
Parent-reported anxiety symptoms immediately at 6 months
Time frame: 6 months 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.
Parent-reported anxiety symptoms immediately at 12 months
Time frame: 12 months 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 children's reported depressive symptoms
Time frame: Baseline
Measured by Mood and Feelings Questionnaire - Short Version (MFQS). It assess depressive symptoms experienced in the past two weeks. The MFQS provides an overall score (minimum value 0, maximum value 26). Higher scores indicate more severe symptoms.
Children's reported depressive symptoms immediately after the intervention
Time frame: Immediately after the intervention
Measured by Mood and Feelings Questionnaire - Short Version (MFQS). It assess depressive symptoms experienced in the past two weeks. The MFQS provides an overall score (minimum value 0, maximum value 26). Higher scores indicate more severe symptoms.
Children's reported depressive symptoms at 6 months
Time frame: 6 months after the intervention
Measured by Mood and Feelings Questionnaire - Short Version (MFQS). It assess depressive symptoms experienced in the past two weeks. The MFQS provides an overall score (minimum value 0, maximum value 26). Higher scores indicate more severe symptoms.
Children's reported depressive symptoms at 12 months
Time frame: 12 months after the intervention
Measured by Mood and Feelings Questionnaire - Short Version (MFQS). It assess depressive symptoms experienced in the past two weeks. The MFQS provides an overall score (minimum value 0, maximum value 26). Higher scores indicate more severe symptoms.
Baseline parent-reported depressive symptoms
Time frame: Baseline
Measured by Mood and Feelings Questionnaire Parent-Report (MFQ-P). It assess depressive symptoms experienced in the past two weeks. The MFQS provides an overall score (minimum value 0, maximum value 68). Higher scores indicate more severe symptoms.
Parent-reported depressive symptoms immediately after the intervention
Time frame: Immediately after the intervention
Measured by Mood and Feelings Questionnaire Parent-Report (MFQ-P). It assess depressive symptoms experienced in the past two weeks. The MFQS provides an overall score (minimum value 0, maximum value 68). Higher scores indicate more severe symptoms.
Parent-reported depressive symptoms immediately at 6 months
Time frame: 6 months after the intervention
Measured by Mood and Feelings Questionnaire Parent-Report (MFQ-P). It assess depressive symptoms experienced in the past two weeks. The MFQS provides an overall score (minimum value 0, maximum value 68). Higher scores indicate more severe symptoms.
Parent-reported depressive symptoms immediately at 12 months
Time frame: 12 months after the intervention
Measured by Mood and Feelings Questionnaire Parent-Report (MFQ-P). It assess depressive symptoms experienced in the past two weeks. The MFQS provides an overall score (minimum value 0, maximum value 68). Higher scores indicate more severe symptoms.
28 secondary outcomes
Baseline children's anxiety-related interference
Time frame: Baseline
Children's anxiety-related interference immediately after the intervention
Time frame: Immediately after the intervention
Children's anxiety-related interference at 6 months
Time frame: 6 months after the intervention
Children's anxiety-related interference at 12 months
Time frame: 12 months after the intervention
Baseline parent-reported anxiety-related interference
Time frame: Baseline
Parent-reported anxiety-related interference immediately after the intervention
Time frame: Immediately after the intervention
Parent-reported anxiety-related interference at 6 months
Time frame: 6 months after the intervention
Parent-reported anxiety-related interference at 12 months
Time frame: 12 months after the intervention
Baseline self-esteem
Time frame: Baseline
Self-esteem immediately after the intervention
Time frame: Immediately after the intervention
Self-esteem at 6 months
Time frame: 6 months after the intervention
Self-esteem at 12 months
Time frame: 12 months after the intervention
Baseline social skills
Time frame: Baseline
Social skills immediately after the intervention
Time frame: Immediately after the intervention
Social skills at 6 months
Time frame: 6 months after the intervention
Social skills at 12 months
Time frame: 12 months after the intervention
Baseline social worries
Time frame: Baseline
Social worries immediately after the intervention
Time frame: Immediately after the intervention
Social worries at 6 months
Time frame: 6 months after the intervention
Social worries at 12 months
Time frame: 12 months after the intervention
Baseline cognitive emotion regulation strategies
Time frame: Baseline
Cognitive emotion regulation strategies immediately after the intervention
Time frame: Immediately after the intervention
Cognitive emotion regulation strategies at 6 months
Time frame: 6 months after the intervention
Cognitive emotion regulation strategies at 12 months
Time frame: 12 months after the intervention
Baseline parental depression, anxiety and stress symptoms
Time frame: Baseline
Baseline parental depression, anxiety and stress symptoms
Time frame: Immediately after the intervention
Baseline parental depression, anxiety and stress symptoms
Time frame: 6 months after the intervention
Baseline parental depression, anxiety and stress symptoms
Time frame: 12 months after the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
- 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.
- 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 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.
- Background: PubMed 33882156Melero 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.
- 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 33918640Melero 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.
- Background: PubMed 33511861Melero 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.
- Background: PubMed 27614301Escribano 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.
- 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.
- Super Skills for Life original program's webpageLink 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.
Mireia Orgilés Amorós principal investigator
Miguel Hernandez University of 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: traditional version and Super Skills for Life: computerized version 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 1 Feb 2024. 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?
Results are not available in the source record.
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?
Baseline children's reported anxiety symptoms (time frame: Baseline). The study lists 16 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 NCT05574491, which also lists 10 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 1 Feb 2024.