Clinical trial NCT05809388: Virtual Reality for Parent Training Intervention
Official title: Implementation of Parent Training Through the Use of Virtual Reality: a Randomized, Controlled, Single-blind Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Attention-Deficit/Hyperactivity Disorder (ADHD)
Lead sponsor: IRCCS Centro Neurolesi Bonino Pulejo
Sponsor class: OTHER
First posted: 2023-04-12
Enrollment: 68
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Previous research has shown how parental responses can affect ADHD symptoms by triggering dysfunctional cyclic processes. Therefore, it may be useful within rehabilitative treatments to include parent training (PT). Recent literature data have demonstrated the potential of using virtual reality in the rehabilitation of children with ADHD. No study has been conducted on the use of virtual reality (VS) within a PT program. It is possible to hypothesize that virtual reality, by providing a controlled environment can help the parent improve his or her ability to self-control and perceive the child's difficulties. This allows the parent's empathizing skills to be implemented and reinforces the educational techniques learned during the parent training intervention.

Detailed description: The investigators designed a single-blind, randomized, controlled study on ADHD patients and their parents, with the aim of evaluating the effects of virtual reality support during PT program compared to traditional PT sessions.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with ADHD, according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria;
* Age including 6 to 10 years;
* Subjects with IQ \>70;
* Signed informed consent and the availability of at least one family member to participate in the diagnostic/therapeutic process.

Exclusion Criteria:

* Important comorbidities with psychiatric or neurological syndromes (e.g., epilepsy, known genetic syndromes, infantile cerebral palsy, sensory deficits);
* Subjects under the age of 6 years;
* Subjects older than 10 years of age;
* Subjects diagnosed with intellectual disability (IQ ≤70);
* Informed consent not signed and/or unavailability of at least one family member to participate in the diagnostic/therapeutic process.

Primary outcomes:
measure: Parenting Stress Index
timeFrame: Baseline
measure: Parenting Stress Index
timeFrame: Month 6
measure: Parenting Stress Index
timeFrame: Month 9
measure: The World Health Organization Quality of Life
timeFrame: Baseline
measure: The World Health Organization Quality of Life
timeFrame: Month 6
measure: The World Health Organization Quality of Life
timeFrame: Month 9
measure: Conners Rating Scale
timeFrame: Baseline
measure: Conners Rating Scale
timeFrame: Month 6
measure: Conners Rating Scale
timeFrame: Month 9
Secondary outcomes:
measure: Tower of London Test
timeFrame: T0 (BASELINE) - T1 (SIX MONTHS) - T2 (NINE MONTHS)
measure: Nepsy- II
timeFrame: T0 (BASELINE) - T1 (SIX MONTHS) - T2 (NINE MONTHS)
measure: Parenting Styles Questionnaire
timeFrame: T0 (BASELINE) - T1 (SIX MONTHS) - T2 (NINE MONTHS)
measure: Child behavior Checklist
timeFrame: T0 (BASELINE) - T1 (SIX MONTHS) - T2 (NINE MONTHS)
measure: Test of Multidimensional self-esteem
timeFrame: T0 (BASELINE) - T1 (SIX MONTHS) - T2 (NINE MONTHS)
Other outcomes:
Locations:
city: Messina
country: Italy
facility: IRCCS Centro Neurolesi Bonino Pulejo
Study officials:
References:
citation: Felt BT, Biermann B, Christner JG, Kochhar P, Harrison RV. Diagnosis and management of ADHD in children. Am Fam Physician. 2014 Oct 1;90(7):456-64.
citation: Lange KW, Reichl S, Lange KM, Tucha L, Tucha O. The history of attention deficit hyperactivity disorder. Atten Defic Hyperact Disord. 2010 Dec;2(4):241-55. doi: 10.1007/s12402-010-0045-8. Epub 2010 Nov 30.
citation: Mulligan A, Anney R, Butler L, O'Regan M, Richardson T, Tulewicz EM, Fitzgerald M, Gill M. Home environment: association with hyperactivity/impulsivity in children with ADHD and their non-ADHD siblings. Child Care Health Dev. 2013 Mar;39(2):202-12. doi: 10.1111/j.1365-2214.2011.01345.x. Epub 2011 Dec 14.
citation: Hosainzadeh Maleki Z, Mashhadi A, Soltanifar A, Moharreri F, Ghanaei Ghamanabad A. Barkley's Parent Training Program, Working Memory Training and their Combination for Children with ADHD: Attention Deficit Hyperactivity Disorder. Iran J Psychiatry. 2014 Apr;9(2):47-54.
citation: Mulvihill A, Carroll A, Dux PE, Matthews N. Self-directed speech and self-regulation in childhood neurodevelopmental disorders: Current findings and future directions. Dev Psychopathol. 2020 Feb;32(1):205-217. doi: 10.1017/S0954579418001670.
citation: Modesto-Lowe V, Danforth JS, Brooks D. ADHD: does parenting style matter? Clin Pediatr (Phila). 2008 Nov;47(9):865-72. doi: 10.1177/0009922808319963. Epub 2008 Jun 16.
citation: Sibley MH, Graziano PA, Ortiz M, Rodriguez L, Coxe S. Academic impairment among high school students with ADHD: The role of motivation and goal-directed executive functions. J Sch Psychol. 2019 Dec;77:67-76. doi: 10.1016/j.jsp.2019.10.005. Epub 2019 Nov 22.
citation: Zwi M, Jones H, Thorgaard C, York A, Dennis JA. Parent training interventions for Attention Deficit Hyperactivity Disorder (ADHD) in children aged 5 to 18 years. Cochrane Database Syst Rev. 2011 Dec 7;2011(12):CD003018. doi: 10.1002/14651858.CD003018.pub3.
citation: Bashiri A, Ghazisaeedi M, Shahmoradi L. The opportunities of virtual reality in the rehabilitation of children with attention deficit hyperactivity disorder: a literature review. Korean J Pediatr. 2017 Nov;60(11):337-343. doi: 10.3345/kjp.2017.60.11.337. Epub 2017 Nov 27.
citation: Venuti, P., & Senese, V. P. (2007). Un questionario di autovalutazione degli stili parentali: Uno studio su un campione Italiano [A questionnaire of self parental styles: A study of an Italian sample]. Giornale Italiano di Psicologia, 34(3), 677-697.