Social CompetenceNCT06031701
Neuro-psychosocial Teleassistance for Neuromuscular Diseases
A study testing Neuro-psychosocial teleassistance program in people with Social Competence and Self Esteem, run by University of Deusto at 1 site in Spain.
Trial summary
This is a clinical trial to assess the effect of a neuropsychosocial intervention by means of telecare aimed at children and adolescents aged 7-16 years with neuromuscular diseases. The intervention is carried out in groups of 5 participants and is organised in 12 sessions: 1 session per week of 1h duration. Read more about this study
- Who is it for?
- Ages 7 to 16 years
- Conditions the study is for
- Social Competence, Self Esteem, Quality of Life
- What is being tested?
- Neuro-psychosocial teleassistance program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteSpain
- Study dates
- 2 Nov 2021to 30 Jun 2023
- 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 7 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- To be diagnosed with a neuromuscular disease by a specialist
- Being between 7 and 16 years old
- Having signed an informed consent form through their legal guardians prior to participation in the study
- Having Spanish as one of their main languages
- Having access to a computer (with a camera, microphone and speakers integrated) and Internet connection to take part in the videoconferences
Who cannot join
- Presence of any other diagnosis or sensory deficit that would prevent the application of the tests or hinder the correct performance of the intervention´s activities
- Being illiterate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Neuro-psychosocial Teleassistance Programme for Children With Neuromuscular Diseases
This is a clinical trial to assess the effect of a neuropsychosocial intervention by means of telecare aimed at children and adolescents aged 7-16 years with neuromuscular diseases. The intervention is carried out in groups of 5 participants and is organised in 12 sessions: 1 session per week of 1h duration. The intervention is aimed at strengthening aspects of social cognition, self-esteem, social skills and aims at a reduction of symptomatology and a general improvement of psychological well-being.
Read the detailed description
Development of a neuro-psychosocial tele-assistance programme for groups of children and adolescents affected by various neuromuscular diseases, including Duchenne/Becker muscular dystrophy, limb-girdle dystrophy, etc. In this project the variables of interest and intervention include social cognition, quality of life, psychological symptomatology and coping strategies. The aim of this study is to test whether this programme improves the indicators in the mentioned variables.
- Being tested
- Neuro-psychosocial teleassistance program
- Medical subject headings
- Social Skills, Neuromuscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuro-psychosocial teleassistance programBehavioural
The intervention is carried out in groups of 5 participants and is organised in 12 sessions: 1 session per week of 1h duration. The intervention is aimed at strengthening aspects of social cognition, self-esteem, social skills and aims at a reduction of symptomatology and a general improvement of psychological well-being.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Neuro-psychosocial intervention with 12 grupal sessions is offered Receives: Behavioral: Neuro-psychosocial teleassistance program |
| Control | Experimental | Waiting list control group Receives: Behavioral: Neuro-psychosocial teleassistance program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Social cognition - Emotion Recognition
Affect Recognition subtest of the Social Perception Domain of the NEPSY-II in the Spanish edition (Korkman et al., 2014) measures the capacity to identify emotions (happy, sad, neutral, afraid, irrationally angry, and disgust) in various images of children
Measured: 3 months after the intervention
Social cognition - Theory of mind - NEPSY-II
Theory of Mind subtest of the Social Perception Domain of the NEPSY-II in the Spanish edition (Korkman et al., 2014) assesses figurative language, imitation skills, and the capacity to comprehend the thoughts, ideas, and beliefs of others and it also evaluates a person's capacity to comprehend how emotions relate to the social context.
Measured: 3 months after the intervention
Social cognition - Theory of mind - Happé's Strange Stories
The Happé's Strange Stories Test is a well-known test of ToM (Happé, 1994; Spanish version: Pousa, 2002). In this study, we used the White et al. (2009) version that has eight story-types. This test evaluates participants capacity to comprehend nonliteral meanings through the reading of brief vignettes.
Measured: 3 months after the intervention
Social cognition - Theory of mind - RMETC
The Reading the Mind in the Eyes test Child version (RMETC) (Baron-Cohen et al., 2001; Spanish version: Rueda et al., 2013), is a TOM test that features 28 photos of individuals. The participant's task is to match the picture with one of the four adjectives that best describes the feelings and thoughts of the person in the picture.
Measured: 3 months after the intervention
Secondary outcomes (4)
Health-related quality of life
How an individual's health status impacts their overall well-being and ability to lead a satisfying life
The perception of HRQoL is assessed in both healthy and chronically ill children using the Spanish version of the Pediatric Quality of Life Inventory (PedsQLTM 4.0) (Varni et al., 2001). We used the self-report questionnaire in this study for three age ranges: 5-7, 8-12, and 13-18. Physical functioning, emotional functioning, social functioning, and academic functioning are the four dimensions covered by the 23-item assessment. The PedsQL 4.0 provides a physical and a psychosocial summary score in addition to a total score. It is answered through a likert scale with 5 response options that are then converted into quantitative scores ranging from 0-100 points, with a higher score being a better HRQoL.
Measured: 3 months after the intervention
Psychopathology
Behavioral and emotional symptoms
The Child Behavior Checklist for Ages 6-18 (CBCL/6-18) (Achenbach \& Rescorla, 2001) is a multiaxial assessment tool for identifying behavioral and emotional issues in children and adolescents that is aligned with the ASEBA (Achenbach System of Empirically Based Assessment). It has 113 items total, broken down into eight scales for the following syndromes: anxious/depressed, withdrawn/depressed, somatic complaints, social problems, thinking problems, attention problems, rule-breaking behavior and aggressive behavior. Scores for internalizing, externalizing, and overall difficulties are also provided by the items.
Measured: 3 months after the intervention
Coping strategies - EAN
Different styles to deal with stressful situations
Coping Scale for Children (EAN) (Morales-Rodríguez et al., 2012) is a self-report scale assesses coping strategies and is intended for children aged nine to 12 years. In the instrument, four problems related to the family context, health, schoolwork and social relationships are posed. The nine coping strategies assessed are distinguished between problem-focused coping and unproductive coping.
Measured: 3 months after the intervention
Coping strategies - ACS
Different styles to deal with stressful situations
Adolescent Coping Scales (ACS) (3rd edition) (Frydenberg and Lewis, 2000): assesses different coping strategies in adolescents aged 12-18 years to cope with their problems. The inventory assesses 18 different coping strategies and consists of 80 items, 79 closed-ended and one open-ended. Furthermore, the 18 strategies are classified into three basic coping styles: problem-directed coping, coping in relation to others, and unproductive coping.
Measured: 3 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 posted11 Sep 2023
- Study start2 Nov 2021
- Primary completion30 Nov 2022
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Social CompetenceStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Quasi-experimental pretest-posttest design with a non-equivalent wait list control group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Deusto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Oscar Martínez, PhD, Principal investigator, University of Deusto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06031701
- Sponsor's protocol ID
- Neuro-e-Motion NMD
- Status last verified
- Jan 2024
- First submitted
- 13 Jul 2023
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The plan is open for other researchers to contact the principal investigator of the study.
Publications
Garcia I, Martinez O, Amayra I, Salgueiro M, Rodriguez AA, Lopez-Paz JF. Effects of a neuropsychosocial teleassistance intervention on social cognition and health-related quality of life of pediatric patients with neuromuscular diseases. J Pediatr Psychol. 2024 Aug 1;49(8):525-535. doi: 10.1093/jpepsy/jsae013.
PubMed 38452290
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Neuro-psychosocial Teleassistance Programme for Children With Neuromuscular Diseases
- ClinicalTrials.gov ID
- NCT06031701
- Acronym / sponsor ID
- Neuro-e-Motion NMD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of DeustoUniversity, hospital or other
- Study start
- 2 Nov 2021 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 11 Sep 2023 (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.
This is a clinical trial to assess the effect of a neuropsychosocial intervention by means of telecare aimed at children and adolescents aged 7-16 years with neuromuscular diseases. The intervention is carried out in groups of 5 participants and is organised in 12 sessions: 1 session per week of 1h duration. The intervention is aimed at strengthening aspects of social cognition, self-esteem, social skills and aims at a reduction of symptomatology and a general improvement of psychological well-being.
Detailed description
Development of a neuro-psychosocial tele-assistance programme for groups of children and adolescents affected by various neuromuscular diseases, including Duchenne/Becker muscular dystrophy, limb-girdle dystrophy, etc. In this project the variables of interest and intervention include social cognition, quality of life, psychological symptomatology and coping strategies. The aim of this study is to test whether this programme improves the indicators in the mentioned variables.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Quasi-experimental pretest-posttest design with a non-equivalent wait list control group
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Neuro-psychosocial teleassistance programNeuro-psychosocial intervention with 12 grupal sessions is offered |
| Control | Experimental | Behavioral: Neuro-psychosocial teleassistance programWaiting list control group |
Who may qualify
- Ages
- 7 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- To be diagnosed with a neuromuscular disease by a specialist
- Being between 7 and 16 years old
- Having signed an informed consent form through their legal guardians prior to participation in the study
- Having Spanish as one of their main languages
- Having access to a computer (with a camera, microphone and speakers integrated) and Internet connection to take part in the videoconferences
Key exclusion criteria (2 listed)
- Presence of any other diagnosis or sensory deficit that would prevent the application of the tests or hinder the correct performance of the intervention´s activities
- Being illiterate
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 |
|---|---|---|
| Neuro-psychosocial teleassistance programThe intervention is carried out in groups of 5 participants and is organised in 12 sessions: 1 session per week of 1h duration. The intervention is aimed at strengthening aspects of social cognition, self-esteem, social skills and aims at a reduction of symptomatology and a general improvement of psychological well-being. | Behavioural | Control, Intervention |
Primary outcome
Social cognition - Emotion Recognition
Time frame: 3 months after the intervention
Affect Recognition subtest of the Social Perception Domain of the NEPSY-II in the Spanish edition (Korkman et al., 2014) measures the capacity to identify emotions (happy, sad, neutral, afraid, irrationally angry, and disgust) in various images of children
Social cognition - Theory of mind - NEPSY-II
Time frame: 3 months after the intervention
Theory of Mind subtest of the Social Perception Domain of the NEPSY-II in the Spanish edition (Korkman et al., 2014) assesses figurative language, imitation skills, and the capacity to comprehend the thoughts, ideas, and beliefs of others and it also evaluates a person's capacity to comprehend how emotions relate to the social context.
Social cognition - Theory of mind - Happé's Strange Stories
Time frame: 3 months after the intervention
The Happé's Strange Stories Test is a well-known test of ToM (Happé, 1994; Spanish version: Pousa, 2002). In this study, we used the White et al. (2009) version that has eight story-types. This test evaluates participants capacity to comprehend nonliteral meanings through the reading of brief vignettes.
Social cognition - Theory of mind - RMETC
Time frame: 3 months after the intervention
The Reading the Mind in the Eyes test Child version (RMETC) (Baron-Cohen et al., 2001; Spanish version: Rueda et al., 2013), is a TOM test that features 28 photos of individuals. The participant's task is to match the picture with one of the four adjectives that best describes the feelings and thoughts of the person in the picture.
4 secondary outcomes
Health-related quality of life
Time frame: 3 months after the intervention
Psychopathology
Time frame: 3 months after the intervention
Coping strategies - EAN
Time frame: 3 months after the intervention
Coping strategies - ACS
Time frame: 3 months 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 17 Jan 2024.
- Derived from this study: PubMed 38452290Garcia I, Martinez O, Amayra I, Salgueiro M, Rodriguez AA, Lopez-Paz JF. Effects of a neuropsychosocial teleassistance intervention on social cognition and health-related quality of life of pediatric patients with neuromuscular diseases. J Pediatr Psychol. 2024 Aug 1;49(8):525-535. doi: 10.1093/jpepsy/jsae013.
- Individual participant dataSharing planned: Yes. The plan is open for other researchers to contact the principal investigator of the study.
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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.
Oscar Martínez, PhD principal investigator
University of Deusto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuro-psychosocial teleassistance program in people with Social Competence and Self Esteem, run by University of Deusto 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 5 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 17 Jan 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?
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?
Social cognition - Emotion Recognition (time frame: 3 months after the intervention). The study lists 4 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 NCT06031701, which also lists 1 linked publication.
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 17 Jan 2024.