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

NCT05368324 | Unknown DMC

• 1 other identifier: UGranadaII
• Study Type: interventional
• Target: 82
• Locations: 0 countries
• Sites: N/A

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.

Conditions

ADHD

Outcome Measures

Primary Outcomes (6)

• 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)

  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)

  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)

  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

  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

  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

  At 6 months

Secondary Outcomes (8)

• Assessment of Executive Function and Sensory Processing (EPYFEI)

  Before and after the intervention (12 weeks)

• Conners Behavior Questionnaire for Parents (SNAP-IV)

  Before and after the intervention (12 weeks)

• Zoo Map Subtest

  Before and after the intervention (12 weeks)

• Stroop Test

  Before and after the intervention (12 weeks)

• Trail Making Test

  Before and after the intervention (12 weeks)

Study Arms (2)

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.

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.

Behavioral: CogFun-RV

Interventions

CogFun-RV 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.

CogFun-RV; Control group on waiting list

Eligibility Criteria

• Age: 9 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad de Granada: lead

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Central Study Contacts

Dulce Romero-Ayuso, PhD

CONTACT

+34958248052; dulceromero@ugr.es

José M Triviño-Juárez, PhD

CONTACT

+34958248052; jmtjuarez@ugr.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All participants will be evaluated by an independent evaluator who will be blinded. The statistician will also be blinded, will not participate in the evaluation or intervention. For analysis it will only be revealed as group A or group B. Only when the analyzes have been completed will the exact nature of the groups be revealed.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized clinical trial, with a control group on the waiting list.

Study Record Dates

• First Submitted: May 1, 2022
• First Posted: May 10, 2022
• Study Start: June 1, 2022
• Primary Completion: June 28, 2024
• Study Completion: December 13, 2024
• Last Updated: May 20, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share