Improvement of Planning Skills in Children and Adolescents With ADHD Through a Virtual Reality System: CogFun-RV

NCT ID: NCT05368324

Last Updated: 2022-05-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2024-12-13

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.

Conditions

ADHD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

CogFun-RV

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.

Group Type: EXPERIMENTAL

CogFun-RV

Intervention Type: BEHAVIORAL

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.

Control group on waiting list

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.

Group Type: OTHER

CogFun-RV

Intervention Type: BEHAVIORAL

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.

Interventions

CogFun-RV

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad de Granada

OTHER

Sponsor Role: lead

Responsible Party

Dulce Romero Ayuso

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Dulce Romero-Ayuso, PhD

Role: CONTACT

dulceromero@ugr.es

+34958248052

José M Triviño-Juárez, PhD

Role: CONTACT

jmtjuarez@ugr.es

+34958248052

Other Identifiers

UGranadaII

Identifier Type: -

Identifier Source: org_study_id