Super Skills for Life Effectiveness in Clinical Settings

May 8, 2023 updated by: Mireia Orgilés Amorós, Universidad Miguel Hernandez de Elche

Treatment of Emotional Disorders in Spanish Children: Efficacy of Super Skills for Life Transdiagnostic Treatment

Super Skills for Life (SSL) is a transdiagnostic cognitive-behavioral protocol developed for children aged 6 to 12 with anxiety and comorbid problems (e.g., depression, low self-esteem, and lack of social skills).

SSL consists of eight sessions targeting common risk factors for internalizing disorders such as cognitive distortions, avoidance, emotional management, low self-esteem, social skills deficits and coping strategies.

The aim of the study is to investigate the short- and long-term effects of SSL on internalizing and externalizing symptoms in Spanish children attending the Child and Adolescent Mental Health Services.

Study Overview

Detailed Description

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

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

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

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

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

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

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Valencia
      • Valence, Valencia, Spain, 46010
        • Hospital Clínico Universitario Valencia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 12 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
Super Skills for Life intervention group

Structured and manualized intervention with a manual for the therapist and a workbook for the children.

Spanish version of Super Skills for Life group program: Orgilés, M., Espada, J.P., Ollendick, T.H. & Essau, C. (2022). Programa Super Skills. Manual del aplicador. Elche, ES: Universidad Miguel Hernández.

The intervention was administered by a trained clinical psychologist in SSL. Sessions were held after school hours once a week for eight weeks, with each session lasting approximately one hour. The contents of the program were covered through playful activities in groups of 4 to 6 children

No Intervention: Wait-list group
Group without any intervention. Participants in the wait-list group received no phycological (public or private) intervention during the eight-week duration of the SSL program. They were informed that children in this group will receive the intervention once the follow-up visit is completed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Children's reported anxiety symptoms at 3 months
Time Frame: 3 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.
3 months after the intervention
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.
6 months after the intervention
Parent-reported anxiety-related interference at 3 months
Time Frame: 3 months 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.
3 months after the intervention
Parent-reported anxiety-related interference at 6 months
Time Frame: 6 months 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.
6 months after the intervention
Change from baseline diagnosis based on DSM-5 criteria to immediately after the intervention
Time Frame: baseline and immediately after the intervention
Measured by Schedule for affective disorders and schizophrenia for schoolage youths-present and lifetime version (K-SADS-PL). The K-SADS-PL is a semi-structured interview for children and adolescents aged 6 to 18 years according to DSM-IV criteria. Additional questions were included in this study to obtain a diagnosis according to the current DSM-5 classification.
baseline and immediately after the intervention
Diagnosis based on DSM-5 criteria at 3 months
Time Frame: 3 months after the intervention
Measured by Schedule for affective disorders and schizophrenia for schoolage youths-present and lifetime version (K-SADS-PL). The K-SADS-PL is a semi-structured interview for children and adolescents aged 6 to 18 years according to DSM-IV criteria. Additional questions were included in this study to obtain a diagnosis according to the current DSM-5 classification.
3 months after the intervention
Diagnosis based on DSM-5 criteria at 6 months
Time Frame: 6 months after the intervention
Measured by Schedule for affective disorders and schizophrenia for schoolage youths-present and lifetime version (K-SADS-PL). The K-SADS-PL is a semi-structured interview for children and adolescents aged 6 to 18 years according to DSM-IV criteria. Additional questions were included in this study to obtain a diagnosis according to the current DSM-5 classification.
6 months after the intervention
Diagnosis based on DSM-5 criteria at 1 year
Time Frame: 1 year after the intervention
Measured by Schedule for affective disorders and schizophrenia for schoolage youths-present and lifetime version (K-SADS-PL). The K-SADS-PL is a semi-structured interview for children and adolescents aged 6 to 18 years according to DSM-IV criteria. Additional questions were included in this study to obtain a diagnosis according to the current DSM-5 classification.
1 year after the intervention
Change from baseline depression symptoms to immediately after the intervention
Time Frame: baseline and immediately after the intervention
Measured by Child Depression Inventory (CDI). It assess depressive symptoms experienced in the past two weeks. The CDI provides an overall score (minimum value 0, maximum value 54) and two dimensions values: dysphoria (minimum value 0, maximum value 34), and negative self-esteem (minimum value 0, maximum value 20). Higher scores indicate more severe symptoms.
baseline and immediately after the intervention
Depression symptoms at 3 months
Time Frame: 3 months after the intervention
Measured by Child Depression Inventory (CDI). It assess depressive symptoms experienced in the past two weeks. The CDI provides an overall score (minimum value 0, maximum value 54) and two dimensions values: dysphoria (minimum value 0, maximum value 34), and negative self-esteem (minimum value 0, maximum value 20). Higher scores indicate more severe symptoms.
3 months after the intervention
Depression symptoms at 6 months
Time Frame: 6 months after the intervention
Measured by Child Depression Inventory (CDI). It assess depressive symptoms experienced in the past two weeks. The CDI provides an overall score (minimum value 0, maximum value 54) and two dimensions values: dysphoria (minimum value 0, maximum value 34), and negative self-esteem (minimum value 0, maximum value 20). Higher scores indicate more severe symptoms.
6 months after the intervention
Depression symptoms at 1 year
Time Frame: 1 year after the intervention
Measured by Child Depression Inventory (CDI). It assess depressive symptoms experienced in the past two weeks. The CDI provides an overall score (minimum value 0, maximum value 54) and two dimensions values: dysphoria (minimum value 0, maximum value 34), and negative self-esteem (minimum value 0, maximum value 20). Higher scores indicate more severe symptoms.
1 year after the intervention
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). SCAS-P measures symptoms severity of the DSM-IV anxiety disorders in children (subscales: total, panic and agoraphobia, generalized anxiety disorder, obsessive-compulsive disorder, social phobia, separation anxiety and specific fears). Symptom frequency is recorded on a 3-point Likert scale from 0 (never) to 3 (always). This yields a minimum possible score of 0 and a maximum possible score of 114. Higher scores indicating greater severity of symptoms.
baseline and immediately after the intervention
Change from baseline children's reported anxiety symptoms to immediately after the intervention
Time Frame: baseline and immediately after the intervention
Measured by Spence Children's Anxiety Scale Child Report (SCAS). SCAS measures symptoms severity of the DSM-IV anxiety disorders in children (subscales: total, panic and agoraphobia, generalized anxiety disorder, obsessive-compulsive disorder, social phobia, separation anxiety and specific fears). Symptom frequency is recorded on a 3-point Likert scale from 0 (never) to 3 (always). This yields a minimum possible score of 0 and a maximum possible score of 114. Higher scores indicating greater severity of symptoms.
baseline and immediately after the intervention
Parent-reported anxiety symptoms at 3 months
Time Frame: 3 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.
3 months after the intervention
Parent-reported anxiety symptoms 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.
6 months after the intervention
Parent-reported anxiety symptoms at 1 year
Time Frame: 1 year 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.
1 year after the intervention
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). SCAS measures symptoms severity of the DSM-IV anxiety disorders in children (subscales: total, panic and agoraphobia, generalized anxiety disorder, obsessive-compulsive disorder, social phobia, separation anxiety and specific fears). Symptom frequency is recorded on a 3-point Likert scale from 0 (never) to 3 (always). This yields a minimum possible score of 0 and a maximum possible score of 114. Higher scores indicating greater severity of symptoms.
1 year after the intervention
Change from baseline parent-reported anxiety-related interference to immediately after the intervention
Time Frame: baseline and immediately after the intervention
Measured by Child Anxiety Life Interference Scale Parent Report (CALIS-P). It assesses life interference and impairment related to anxiety in the child's school, social, and home/family settings. Scores range from a minimum value of 0 to a maximun value of 64. Higher scores indicate larger child anxiety-related interference.
baseline and immediately after the intervention
Change from baseline children's reported anxiety-related interference to immediately after the intervention
Time Frame: baseline and immediately after the intervention
Measured by Child Anxiety Life Interference Scale Child Report (CALIS-C). It assesses life interference and impairment related to anxiety in the child's school, social, and home/family settings. Scores range from a minimum value of 0 to a maximun value of 36. Higher scores indicate larger child anxiety-related interference.
baseline and immediately after the intervention
Children's reported anxiety-related interference at 3 months
Time Frame: 3 months 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.
3 months after the intervention
Children's reported anxiety-related interference at 6 months
Time Frame: 6 months 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.
6 months after the intervention
Parent-reported anxiety-related interference at 1 year
Time Frame: 1 year 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.
1 year after the intervention
Children's reported anxiety-related interference at 1 year
Time Frame: 1 year 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.
1 year after the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-esteem at 3 months
Time Frame: 3 months 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.
3 months after the intervention
Self-esteem at 6 months
Time Frame: 6 months 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.
6 months after the intervention
Change from baseline children's reported global mental health symptoms 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 maximun 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.
baseline and immediately after the intervention
Change from baseline parent's reported global mental health symptoms to immediately after the intervention
Time Frame: baseline and immediately after the intervention
Measured by Strengths and Difficulties Questionnaire Parent 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.
baseline and immediately after the intervention
Children's reported global mental health symptoms at 3 months
Time Frame: 3 months 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 maximun 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.
3 months after the intervention
Parent's reported global mental health symptoms at 3 months
Time Frame: 3 months after the intervention
Measured by Strengths and Difficulties Questionnaire Parent 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.
3 months after the intervention
Children's reported global mental health symptoms at 6 months
Time Frame: 6 months 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 maximun 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.
6 months after the intervention
Parent's reported global mental health symptoms at 6 months
Time Frame: 6 months after the intervention
Measured by Strengths and Difficulties Questionnaire Parent 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.
6 months after the intervention
Children's reported global mental health symptoms 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 maximun 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.
1 year after the intervention
Parent's reported global mental health symptoms at 1 year
Time Frame: 1 year after the intervention
Measured by Strengths and Difficulties Questionnaire Parent 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.
1 year after the intervention
Change from baseline self-esteem to immediately after the intervention
Time Frame: baseline and 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.
baseline and immediately after the intervention
Self-esteem at 1 year
Time Frame: 1 year 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.
1 year after the intervention
Perfectionism
Time Frame: pre-intervention
Frost Multidimensional Perfectionism Scale (FMPS). A self-report measure with four sub-scales of perfectionism: concern over mistakes and doubts about actions, excessive concern with parents' expectations and evaluation, excessively high personal standards, concern with precision, order and organisation.
pre-intervention
Changes from baseline health-related quality of life to immediately after the intervention
Time Frame: baseline and immediately after the intervention
Health-Related Quality of Life Questionnaire for Children and Adolescents aged from 8 to 18 years (KIDSCREEN). It assess children's and parents' subjective health and well-being in 10 areas.
baseline and immediately after the intervention
Health-related quality of life at 3 months
Time Frame: 3 months after the intervention
Health-Related Quality of Life Questionnaire for Children and Adolescents aged from 8 to 18 years (KIDSCREEN). It assess children's and parents' subjective health and well-being in 10 areas.
3 months after the intervention
Health-related quality of life at 6 months
Time Frame: 6 months after the intervention
Health-Related Quality of Life Questionnaire for Children and Adolescents aged from 8 to 18 years (KIDSCREEN). It assess children's and parents' subjective health and well-being in 10 areas.
6 months after the intervention
Health-related quality of life at 1 year
Time Frame: 1 year after the intervention
Health-Related Quality of Life Questionnaire for Children and Adolescents aged from 8 to 18 years (KIDSCREEN). It assess children's and parents' subjective health and well-being in 10 areas.
1 year after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Sara Diego, Universidad Miguel Hernandez de Elche
  • Study Director: Mireia Orgiles, Universidad Miguel Hernandez de Elche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2018

Primary Completion (Actual)

December 14, 2022

Study Completion (Actual)

December 14, 2022

Study Registration Dates

First Submitted

July 22, 2022

First Submitted That Met QC Criteria

July 28, 2022

First Posted (Actual)

August 1, 2022

Study Record Updates

Last Update Posted (Actual)

May 10, 2023

Last Update Submitted That Met QC Criteria

May 8, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All IPD

IPD Sharing Time Frame

Starting after finishing all analysis and publication.

IPD Sharing Access Criteria

Upon request and verification by the principal investigator to consult the available data. The use of the data for distribution in any format is not permitted.

IPD Sharing Supporting Information Type

  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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