Clinical trial NCT05368324: Improvement of Planning Skills in Children and Adolescents With ADHD Through a Virtual Reality System: CogFun-RV
Official title: Improvement of Planning Skills in Daily Life in Children and Adolescents With ADHD Through a Virtual Reality System: CogFun-RV
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: ADHD
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2022-05-10
Enrollment: 82
Sex: ALL
Minimum age (years): 9
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Randomized clinical trial, with a control group on the waiting list.
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion criteria:

* Age between 9 and 17 years
* Clinical diagnosis of ADHD
* With stable pharmacological treatment

Exclusion criteria:

* 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

Primary outcomes:
measure: Weiss Functional Impairment Rating Scale-Parent Form for assessing ADHD
timeFrame: After the Intervention (12 weeks)
measure: Weiss Functional Impairment Rating Scale-Parent Form for assessing ADHD
timeFrame: At 3 months
measure: Weiss Functional Impairment Rating Scale-Parent Form for assessing ADHD
timeFrame: At 6 months
measure: Self-assessment of daily time management in children (TIME-S)
timeFrame: After the intervention: 12 weeks
measure: Self-assessment of daily time management in children (TIME-S)
timeFrame: At 3 months
measure: Self-assessment of daily time management in children (TIME-S)
timeFrame: At 6 months
Secondary outcomes:
measure: Assessment of Executive Function and Sensory Processing (EPYFEI)
timeFrame: Before and after the intervention (12 weeks)
measure: Conners Behavior Questionnaire for Parents (SNAP-IV)
timeFrame: Before and after the intervention (12 weeks)
measure: Zoo Map Subtest
timeFrame: Before and after the intervention (12 weeks)
measure: Stroop Test
timeFrame: Before and after the intervention (12 weeks)
measure: Trail Making Test
timeFrame: Before and after the intervention (12 weeks)
measure: Digit test
timeFrame: Before and after the intervention (12 weeks)
measure: Emotional intelligence scale EQ-i:Yv
timeFrame: Before and after the intervention (12 weeks)
measure: Strengths and Difficulties Questionnaire (SDQ)-parents
timeFrame: Before and after the intervention (12 weeks)
Other outcomes:
Locations:
Study officials:
References: