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Studies

Interventional Not yet recruiting

NCT05368324 on ClinicalTrials.gov

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

  • Sponsor: University of Granada
  • Enrollment: 82 (Estimated)
  • Study start: 2022-06-01 (Estimated)
  • Primary completion: 2024-06-28 (Estimated)
  • Study completion: 2024-12-13 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Sequential
  • InterventionModelDescription: Randomized clinical trial, with a control group on the waiting list.
  • Masking: Double (Investigator, Outcomes Assessor)
  • PrimaryPurpose: 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.

Conditions

  • ADHD

Intervention / Treatment

  • Behavioral: CogFun-RV

Primary Outcome Measures

  • Weiss Functional Impairment Rating Scale-Parent Form for assessing ADHD (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 (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 (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) (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) (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) (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