ADHDCogFun-RVNCT05368324
Improvement of Planning Skills in Children and Adolescents With ADHD Through a Virtual Reality System: CogFun-RV
A study testing CogFun-RV in people with ADHD, run by Universidad de Granada.
Trial summary
The main aim is to know the effectiveness of a program, CogFun-VR, through the use of immersive virtual reality, to improve executive skills, such as self-regulation, organization, planning and time management in life. of children and adolescents with ADHD, between 9 and 16 years old. Read more about this study
- Who is it for?
- Ages 9 to 17 years
- Conditions the study is for
- ADHD
- What is being tested?
- CogFun-RV
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2022to 13 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 9 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age between 9 and 17 years
- Clinical diagnosis of ADHD
- With stable pharmacological treatment
Who cannot join
- Children with disorders comorbid with ASD and severe behavioural disorders
- With other non-pharmacological treatments
- That they start a new pharmacological or non-pharmacological treatment during the duration of the study (they will not be considered for the analysis of the results).
- Have visual deficits that prevent the use of virtual reality glasses
- Present symptoms of Cybersickness
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Improvement of Planning Skills in Daily Life in Children and Adolescents With ADHD Through a Virtual Reality System: CogFun-RV
The main aim is to know the effectiveness of a program, CogFun-VR, through the use of immersive virtual reality, to improve executive skills, such as self-regulation, organization, planning and time management in life. of children and adolescents with ADHD, between 9 and 16 years old.
The study design is a randomized clinical trial, with a control group on a waiting list. The estimated sample size is 82 participants: 41 in the experimental group and 41 in the control group.
Participants will be randomly assigned to one of the two groups. Four measurements of the variables of interest will be conducted, in the beginning, after the 12-week duration of the intervention, at 3 months and 6 months as a follow-up. The BRIEF, SNAP-IV, SDQ, EQi: YV and several subtests of the WISC-%, BADS and NEPSY-II will be used. All participants will be assessed by an independent evaluator who will be blinded. The intervention program is manualized to assess its integrity and reliability.
Read the detailed description
Planning skills are one of the difficulties that children with ADHD show, being reflected in four of the nine symptoms of inattention according to the DSM-5. In addition, these skills have been associated with performance in different daily, academic, work and leisure activities.
The main objective of the study is to know the effectiveness of an innovative treatment to improve executive skills, such as planning, organization and time management in daily life in children and adolescents between 9 and 16 years old with a diagnosis of ADHD, through a program multimodal of 12 individual sessions of 75 minutes.
The study design is a randomized clinical trial, with a control group on a waiting list. The estimated number of participants is 82, 41 participants in the experimental group and 41 children in the control group on the waiting list. Participants will be randomly assigned to one of two groups. Three measurements of the variables of interest will be made. All participants will be evaluated by an independent evaluator who will be blinded. The intervention program is manualized in order to assess its integrity and reliability. All sessions are divided into two parts: 1) intervention through an immersive virtual reality system, called COGFUN-RV, lasting 30 minutes and 2) teaching strategies to improve cognitive and emotional self-regulation skills. for another 30 minutes. Each session will include practice, at home or at school, of the strategies learned until the next session. The intervention proposal incorporates 15 minutes of psychoeducation with the parents in each session. The project has been submitted for approval to the Ethics and Human Research Committee of the University of Granada, as well as to the PEIBA. All legal guardians will have to give their informed consent and authorization to participate in the project.
The program represents a novelty in the current treatment for several reasons. First, until now most programs have focused only on basic executive functions, such as working memory, inhibitory control, or cognitive flexibility. Instead, this proposal focuses especially on advanced executive functions, such as planning, organization, time management, and problem solving. Secondly, the main approach is through a virtual reality system, in which the child must plan, manage time, organize the action and regulate its emotions, according to the different actions carried out in the activity. The main characteristic of the virtual proposal is to increase the transfer to daily life and, therefore, the ecological validity.
- Conditions
- ADHD
- Being tested
- CogFun-RV
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CogFun-RVBehavioural
CogFun-RV intervention combines training in daily living skills, organization, task planning, time organization, emotional regulation, self-esteem and mindfulness in children and the parents. It consists of 12 sessions, each lasting 75 minutes. Parents will participate in the parental guidance and psychoeducation program with one of the two therapists assigned to the child. As it is a program of a simultaneous nature, excessive impact on the daily life of families is avoided. All sessions will be carried out individually.
| Study group | Role | What they receive |
|---|---|---|
| CogFun-RV | Experimental | It consists of 12 sessions, each lasting 75 minutes for each children. Parallel parents will participate in the parental guidance and psychoeducation program with one of the two therapists assigned to the child. Receives: Behavioral: CogFun-RV |
| Control group on waiting list | Other | After 6 months, the participants of the control group on the waiting list will be invited to participate if the results of the analysis show positive effects of the intervention. Receives: Behavioral: CogFun-RV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weiss Functional Impairment Rating Scale-Parent Form for assessing ADHD
The Weiss Functional Impairment Rating Scale- Parent Form (WFIRS-P) is a 50-item scale that assesses functional impairment on six clinically relevant domains typically affected in attention-deficit/hyperactivity disorder (ADHD)
Measured: After the Intervention (12 weeks)
Weiss Functional Impairment Rating Scale-Parent Form for assessing ADHD
The Weiss Functional Impairment Rating Scale Parent Form (WFIRS-P) is a 50-item scale that assesses functional impairment on six clinically relevant domains typically affected in attention-deficit/hyperactivity disorder (ADHD)
Measured: At 3 months
Weiss Functional Impairment Rating Scale-Parent Form for assessing ADHD
The Weiss Functional Impairment Rating Scale- Parent Form (WFIRS-P) is a 50-item scale that assesses functional impairment on six clinically relevant domains typically affected in attention-deficit/hyperactivity disorder (ADHD)
Measured: At 6 months
Self-assessment of daily time management in children (TIME-S)
Self-assessment for children with disabilities ages 10-17 ability of time perception, time orientation andknowledge on time management in children 10-17 years old
Measured: After the intervention: 12 weeks
Self-assessment of daily time management in children (TIME-S)
Self-assessment for children with disabilities ages 10-17 ability of time perception, time orientation andknowledge on time management in children 10-17 years old
Measured: At 3 months
Self-assessment of daily time management in children (TIME-S)
Self-assessment for children with disabilities ages 10-17 ability of time perception, time orientation andknowledge on time management in children 10-17 years old
Measured: At 6 months
Secondary outcomes (8)
Assessment of Executive Function and Sensory Processing (EPYFEI)
Questionnaire for parent.Scores above 46.5 points indicate that there is a deficit in executive functioning in daily life. The higher the score, the worse the result.
Measured: Before and after the intervention (12 weeks)
Conners Behavior Questionnaire for Parents (SNAP-IV)
Behavior scale for children and adolescents with ADHD. Higher score mean worse outcome.
Measured: Before and after the intervention (12 weeks)
Zoo Map Subtest
Planning Skills Cognitive Test.The number of errors is scored, the higher the score, the worse the results. The scores are between 0 and 10.
Measured: Before and after the intervention (12 weeks)
Stroop Test
Cognitive test of selective attention and interference inhibition.The score can be positive or negative. If the score is negative, below zero, it indicates that there are difficulties in inhibiting interference from the environment.
Measured: Before and after the intervention (12 weeks)
Trail Making Test
Cognitive test of sustained and alternating attention.The number of errors and the time it takes to complete the task are collected. Scores vary by age. The higher the number of errors and the longer the execution time, the worse the attention.
Measured: Before and after the intervention (12 weeks)
Digit test
Attentional Span and Working Memory.The higher the score, the better the results. Normal scores range between 6 and 9 digits of attention span.
Measured: Before and after the intervention (12 weeks)
Emotional intelligence scale EQ-i:Yv
Emotional intelligence scale for children and young people.The higher the score, the better the results. The average scores are between 90-100 points.
Measured: Before and after the intervention (12 weeks)
Strengths and Difficulties Questionnaire (SDQ)-parents
Assessment of behavioural problems.The minimum score is 0 and the maximum is 40. The normal score is between 0-13 points. A score greater than 17 was considered abnormal.
Measured: Before and after the intervention (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2022
- Study start1 Jun 2022 (estimated)
- Primary completion28 Jun 2024 (estimated)
- Study completion13 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies 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
- Sequential
- Model description
- Randomized clinical trial, with a control group on the waiting list.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dulce Romero Ayuso, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05368324
- Sponsor's protocol ID
- UGranadaII
- Acronym
- CogFun-RV
- Status last verified
- May 2022
- First submitted
- 1 May 2022
- Last updated
- 20 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement of Planning Skills in Daily Life in Children and Adolescents With ADHD Through a Virtual Reality System: CogFun-RV
- ClinicalTrials.gov ID
- NCT05368324
- Acronym / sponsor ID
- CogFun-RV / UGranadaII
- Conditions
- ADHD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- 1 Jun 2022 (estimated)
- Primary completion
- 28 Jun 2024 (estimated)
- Study completion
- 13 Dec 2024 (estimated)
- First posted
- 10 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main aim is to know the effectiveness of a program, CogFun-VR, through the use of immersive virtual reality, to improve executive skills, such as self-regulation, organization, planning and time management in life. of children and adolescents with ADHD, between 9 and 16 years old.
The study design is a randomized clinical trial, with a control group on a waiting list. The estimated sample size is 82 participants: 41 in the experimental group and 41 in the control group.
Participants will be randomly assigned to one of the two groups. Four measurements of the variables of interest will be conducted, in the beginning, after the 12-week duration of the intervention, at 3 months and 6 months as a follow-up. The BRIEF, SNAP-IV, SDQ, EQi: YV and several subtests of the WISC-%, BADS and NEPSY-II will be used. All participants will be assessed by an independent evaluator who will be blinded. The intervention program is manualized to assess its integrity and reliability.
Detailed description
Planning skills are one of the difficulties that children with ADHD show, being reflected in four of the nine symptoms of inattention according to the DSM-5. In addition, these skills have been associated with performance in different daily, academic, work and leisure activities.
The main objective of the study is to know the effectiveness of an innovative treatment to improve executive skills, such as planning, organization and time management in daily life in children and adolescents between 9 and 16 years old with a diagnosis of ADHD, through a program multimodal of 12 individual sessions of 75 minutes.
The study design is a randomized clinical trial, with a control group on a waiting list. The estimated number of participants is 82, 41 participants in the experimental group and 41 children in the control group on the waiting list. Participants will be randomly assigned to one of two groups. Three measurements of the variables of interest will be made. All participants will be evaluated by an independent evaluator who will be blinded. The intervention program is manualized in order to assess its integrity and reliability. All sessions are divided into two parts: 1) intervention through an immersive virtual reality system, called COGFUN-RV, lasting 30 minutes and 2) teaching strategies to improve cognitive and emotional self-regulation skills. for another 30 minutes. Each session will include practice, at home or at school, of the strategies learned until the next session. The intervention proposal incorporates 15 minutes of psychoeducation with the parents in each session. The project has been submitted for approval to the Ethics and Human Research Committee of the University of Granada, as well as to the PEIBA. All legal guardians will have to give their informed consent and authorization to participate in the project.
The program represents a novelty in the current treatment for several reasons. First, until now most programs have focused only on basic executive functions, such as working memory, inhibitory control, or cognitive flexibility. Instead, this proposal focuses especially on advanced executive functions, such as planning, organization, time management, and problem solving. Secondly, the main approach is through a virtual reality system, in which the child must plan, manage time, organize the action and regulate its emotions, according to the different actions carried out in the activity. The main characteristic of the virtual proposal is to increase the transfer to daily life and, therefore, the ecological validity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized clinical trial, with a control group on the waiting list.
| Arm | Type | Receives |
|---|---|---|
| CogFun-RV | Experimental | Behavioral: CogFun-RVIt consists of 12 sessions, each lasting 75 minutes for each children. Parallel parents will participate in the parental guidance and psychoeducation program with one of the two therapists assigned to the child. |
| Control group on waiting list | Other | Behavioral: CogFun-RVAfter 6 months, the participants of the control group on the waiting list will be invited to participate if the results of the analysis show positive effects of the intervention. |
Who may qualify
- Ages
- 9 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age between 9 and 17 years
- Clinical diagnosis of ADHD
- With stable pharmacological treatment
Key exclusion criteria (5 listed)
- Children with disorders comorbid with ASD and severe behavioural disorders
- With other non-pharmacological treatments
- That they start a new pharmacological or non-pharmacological treatment during the duration of the study (they will not be considered for the analysis of the results).
- Have visual deficits that prevent the use of virtual reality glasses
- Present symptoms of Cybersickness
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 |
|---|---|---|
| CogFun-RVCogFun-RV intervention combines training in daily living skills, organization, task planning, time organization, emotional regulation, self-esteem and mindfulness in children and the parents. It consists of 12 sessions, each lasting 75 minutes. Parents will participate in the parental guidance and psychoeducation program with one of the two therapists assigned to the child. As it is a program of a simultaneous nature, excessive impact on the daily life of families is avoided. All sessions will be carried out individually. | Behavioural | CogFun-RV, Control group on waiting list |
Primary outcome
Weiss Functional Impairment Rating Scale-Parent Form for assessing ADHD
Time frame: After the Intervention (12 weeks)
The Weiss Functional Impairment Rating Scale- Parent Form (WFIRS-P) is a 50-item scale that assesses functional impairment on six clinically relevant domains typically affected in attention-deficit/hyperactivity disorder (ADHD)
Weiss Functional Impairment Rating Scale-Parent Form for assessing ADHD
Time frame: At 3 months
The Weiss Functional Impairment Rating Scale Parent Form (WFIRS-P) is a 50-item scale that assesses functional impairment on six clinically relevant domains typically affected in attention-deficit/hyperactivity disorder (ADHD)
Weiss Functional Impairment Rating Scale-Parent Form for assessing ADHD
Time frame: At 6 months
The Weiss Functional Impairment Rating Scale- Parent Form (WFIRS-P) is a 50-item scale that assesses functional impairment on six clinically relevant domains typically affected in attention-deficit/hyperactivity disorder (ADHD)
Self-assessment of daily time management in children (TIME-S)
Time frame: After the intervention: 12 weeks
Self-assessment for children with disabilities ages 10-17 ability of time perception, time orientation andknowledge on time management in children 10-17 years old
Self-assessment of daily time management in children (TIME-S)
Time frame: At 3 months
Self-assessment for children with disabilities ages 10-17 ability of time perception, time orientation andknowledge on time management in children 10-17 years old
Self-assessment of daily time management in children (TIME-S)
Time frame: At 6 months
Self-assessment for children with disabilities ages 10-17 ability of time perception, time orientation andknowledge on time management in children 10-17 years old
8 secondary outcomes
Assessment of Executive Function and Sensory Processing (EPYFEI)
Time frame: Before and after the intervention (12 weeks)
Conners Behavior Questionnaire for Parents (SNAP-IV)
Time frame: Before and after the intervention (12 weeks)
Zoo Map Subtest
Time frame: Before and after the intervention (12 weeks)
Stroop Test
Time frame: Before and after the intervention (12 weeks)
Trail Making Test
Time frame: Before and after the intervention (12 weeks)
Digit test
Time frame: Before and after the intervention (12 weeks)
Emotional intelligence scale EQ-i:Yv
Time frame: Before and after the intervention (12 weeks)
Strengths and Difficulties Questionnaire (SDQ)-parents
Time frame: Before and after the intervention (12 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2022.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing CogFun-RV in people with ADHD, run by Universidad de Granada.
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 5 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 20 May 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Dulce Romero-Ayuso, PhD (+34958248052, dulceromero@ugr.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weiss Functional Impairment Rating Scale-Parent Form for assessing ADHD (time frame: After the Intervention (12 weeks)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 May 2022.