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Virtual Reality for Parent Training Intervention

Primary Purpose

Attention-Deficit/Hyperactivity Disorder (ADHD)

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Parent training
Virtual Reality-assisted PT sessions
Sponsored by
IRCCS Centro Neurolesi "Bonino-Pulejo"
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Attention-Deficit/Hyperactivity Disorder (ADHD)

Eligibility Criteria

6 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • IRCCS Centro Neurolesi Bonino PulejoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental Group (EG)

Control Group (CG)

Arm Description

The EG will perform a standard Parent Training program. This PT will be supplemented with virtual reality sessions. Each pair of parents will perform a total of 12 treatment sessions fortnightly.

The CG will perform a standard Parent Training program plus two follow up sessions. Each pair of parents will perform a total of 12 treatment sessions fortnightly.

Outcomes

Primary Outcome Measures

Parenting Stress Index
Parenting Stress Index is for the early identification of characteristics that may impair normal child development, such as emotional and behavioral disorders and parents who are at risk of living dysfunctionally in their role; Parenting Stress Index has 36 items based on a five-point Likert scale where each value corresponds to a specific statement (1 = completely disagree; 5 = completely agree). The subscale scores range from 12 to 60, and the Total Stress score ranges from 36 to 180. The higher the score, the greater the level of parental stress.
Parenting Stress Index
Parenting Stress Index is for the early identification of characteristics that may impair normal child development, such as emotional and behavioral disorders and parents who are at risk of living dysfunctionally in their role; Parenting Stress Index has 36 items based on a five-point Likert scale where each value corresponds to a specific statement (1 = completely disagree; 5 = completely agree). The subscale scores range from 12 to 60, and the Total Stress score ranges from 36 to 180. The higher the score, the greater the level of parental stress.
Parenting Stress Index
Parenting Stress Index is for the early identification of characteristics that may impair normal child development, such as emotional and behavioral disorders and parents who are at risk of living dysfunctionally in their role; Parenting Stress Index has 36 items based on a five-point Likert scale where each value corresponds to a specific statement (1 = completely disagree; 5 = completely agree). The subscale scores range from 12 to 60, and the Total Stress score ranges from 36 to 180. The higher the score, the greater the level of parental stress.
The World Health Organization Quality of Life
World Health Organization Quality of Life-BREF consists of 26 questions. World Health Organization Quality of Life has Likert-type scoring ranging from 1 to 5. As the score obtained from the sub-domains of the scale increases, the quality of life increases.
The World Health Organization Quality of Life
World Health Organization Quality of Life-BREF consists of 26 questions. World Health Organization Quality of Life-BREF has Likert-type scoring ranging from 1 to 5. As the score obtained from the sub-domains of the scale increases, the quality of life increases.
The World Health Organization Quality of Life
World Health Organization Quality of Life-BREF consists of 26 questions. World Health Organization Quality of Life-BREF has Likert-type scoring ranging from 1 to 5. As the score obtained from the sub-domains of the scale increases, the quality of life increases.
Conners Rating Scale
Conners: a questionnaire that asks about things like behavior, work or schoolwork, and social life. The Conners-3 Parent Rating Scale (Conners-3-P) is the most recent revision to a widely used behavior rating scale system. The Conners-3-P includes 5 empirically derived scales: Hyperactivity/Impulsivity, Executive Functioning, Learning Problems, Aggression, and Peer Relations.Respondents are asked to rate behavior that has been problematic over the preceding month using a four-point Likert scale labeled with both levels of appropriateness (e.g., "Not true at all" = 0), and frequency (e.g., "Very frequent" = 3).
Conners Rating Scale
Conners: a questionnaire that asks about things like behavior, work or schoolwork, and social life. The Conners-3 Parent Rating Scale (Conners-3-P) is the most recent revision to a widely used behavior rating scale system. The Conners-3-P includes 5 empirically derived scales: Hyperactivity/Impulsivity, Executive Functioning, Learning Problems, Aggression, and Peer Relations.Respondents are asked to rate behavior that has been problematic over the preceding month using a four-point Likert scale labeled with both levels of appropriateness (e.g., "Not true at all" = 0), and frequency (e.g., "Very frequent" = 3).
Conners Rating Scale
Conners: a questionnaire that asks about things like behavior, work or schoolwork, and social life. The Conners-3 Parent Rating Scale (Conners-3-P) is the most recent revision to a widely used behavior rating scale system. The Conners-3-P includes 5 empirically derived scales: Hyperactivity/Impulsivity, Executive Functioning, Learning Problems, Aggression, and Peer Relations.Respondents are asked to rate behavior that has been problematic over the preceding month using a four-point Likert scale labeled with both levels of appropriateness (e.g., "Not true at all" = 0), and frequency (e.g., "Very frequent" = 3).

Secondary Outcome Measures

Tower of London Test
Tower of London Test : is used to assess executive functions, particularly the future implications of one's action
Nepsy- II
Nepsy battery assess a whole range of general attentional and executive functions, such as the ability to inhibit learned automatic responses, to monitor and self-regulate one's own behaviors and responses, selective and sustained attention (vigilance), the ability to understand, generate, maintain, or change a set of response rules, non-verbal problem-solving skills, and the ability to plan and organize complex responses
Parenting Styles Questionnaire
This questionnaire assesses the types of parental styles by presenting a list of qualities and behaviors referred to situations of interaction with the child. Answers are collected using a Likert-scale 5-point, from never (=1) to always (=5). Parenting style is measured by calculating as an average over the items related to each style.
Child behavior Checklist
Child behavior Checklist assesses emotional and behavioral problems in children
Test of Multidimensional self-esteem
TMA is gets an accurate measurement of self-esteem in developmental age a 150-items self-report questionnaire. It's made up of six subscales: interpersonal relationships, environmental control competence, emotionality, scholastic success, family life, body perception. Participants have to express their agreement with each item according to the following response options: absolutely true, true, false, absolutely false.

Full Information

First Posted
March 17, 2023
Last Updated
May 22, 2023
Sponsor
IRCCS Centro Neurolesi "Bonino-Pulejo"
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1. Study Identification

Unique Protocol Identification Number
NCT05809388
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 26, 2022 (Actual)
Primary Completion Date
October 31, 2025 (Anticipated)
Study Completion Date
October 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS Centro Neurolesi "Bonino-Pulejo"

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention-Deficit/Hyperactivity Disorder (ADHD)

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group (EG)
Arm Type
Experimental
Arm Description
The EG will perform a standard Parent Training program. This PT will be supplemented with virtual reality sessions. Each pair of parents will perform a total of 12 treatment sessions fortnightly.
Arm Title
Control Group (CG)
Arm Type
Active Comparator
Arm Description
The CG will perform a standard Parent Training program plus two follow up sessions. Each pair of parents will perform a total of 12 treatment sessions fortnightly.
Intervention Type
Behavioral
Intervention Name(s)
Parent training
Intervention Description
Parent Training program according to "Ten steps of Barkley's program" plus two additional follow-up sessions. This will be conducted by a trained psychologist; each session will last approximately 60 minutes and will includes exercises, discussions and role-playing.
Intervention Type
Behavioral
Intervention Name(s)
Virtual Reality-assisted PT sessions
Intervention Description
The experimental group will follow the same program of CG sample. Parent Training sessions will be conducted by a trained psychologist; each session will last approximately 60 minutes that include: 40 minutes of as usual PT session, with exercises, discussions and role-playing. 20 minutes of VR screen with which the parents may interact; VR screen will provides instructive, stimulating, interactive, and direct feedbacks exercises to enhance parenting strategies.
Primary Outcome Measure Information:
Title
Parenting Stress Index
Description
Parenting Stress Index is for the early identification of characteristics that may impair normal child development, such as emotional and behavioral disorders and parents who are at risk of living dysfunctionally in their role; Parenting Stress Index has 36 items based on a five-point Likert scale where each value corresponds to a specific statement (1 = completely disagree; 5 = completely agree). The subscale scores range from 12 to 60, and the Total Stress score ranges from 36 to 180. The higher the score, the greater the level of parental stress.
Time Frame
Baseline
Title
Parenting Stress Index
Description
Parenting Stress Index is for the early identification of characteristics that may impair normal child development, such as emotional and behavioral disorders and parents who are at risk of living dysfunctionally in their role; Parenting Stress Index has 36 items based on a five-point Likert scale where each value corresponds to a specific statement (1 = completely disagree; 5 = completely agree). The subscale scores range from 12 to 60, and the Total Stress score ranges from 36 to 180. The higher the score, the greater the level of parental stress.
Time Frame
Month 6
Title
Parenting Stress Index
Description
Parenting Stress Index is for the early identification of characteristics that may impair normal child development, such as emotional and behavioral disorders and parents who are at risk of living dysfunctionally in their role; Parenting Stress Index has 36 items based on a five-point Likert scale where each value corresponds to a specific statement (1 = completely disagree; 5 = completely agree). The subscale scores range from 12 to 60, and the Total Stress score ranges from 36 to 180. The higher the score, the greater the level of parental stress.
Time Frame
Month 9
Title
The World Health Organization Quality of Life
Description
World Health Organization Quality of Life-BREF consists of 26 questions. World Health Organization Quality of Life has Likert-type scoring ranging from 1 to 5. As the score obtained from the sub-domains of the scale increases, the quality of life increases.
Time Frame
Baseline
Title
The World Health Organization Quality of Life
Description
World Health Organization Quality of Life-BREF consists of 26 questions. World Health Organization Quality of Life-BREF has Likert-type scoring ranging from 1 to 5. As the score obtained from the sub-domains of the scale increases, the quality of life increases.
Time Frame
Month 6
Title
The World Health Organization Quality of Life
Description
World Health Organization Quality of Life-BREF consists of 26 questions. World Health Organization Quality of Life-BREF has Likert-type scoring ranging from 1 to 5. As the score obtained from the sub-domains of the scale increases, the quality of life increases.
Time Frame
Month 9
Title
Conners Rating Scale
Description
Conners: a questionnaire that asks about things like behavior, work or schoolwork, and social life. The Conners-3 Parent Rating Scale (Conners-3-P) is the most recent revision to a widely used behavior rating scale system. The Conners-3-P includes 5 empirically derived scales: Hyperactivity/Impulsivity, Executive Functioning, Learning Problems, Aggression, and Peer Relations.Respondents are asked to rate behavior that has been problematic over the preceding month using a four-point Likert scale labeled with both levels of appropriateness (e.g., "Not true at all" = 0), and frequency (e.g., "Very frequent" = 3).
Time Frame
Baseline
Title
Conners Rating Scale
Description
Conners: a questionnaire that asks about things like behavior, work or schoolwork, and social life. The Conners-3 Parent Rating Scale (Conners-3-P) is the most recent revision to a widely used behavior rating scale system. The Conners-3-P includes 5 empirically derived scales: Hyperactivity/Impulsivity, Executive Functioning, Learning Problems, Aggression, and Peer Relations.Respondents are asked to rate behavior that has been problematic over the preceding month using a four-point Likert scale labeled with both levels of appropriateness (e.g., "Not true at all" = 0), and frequency (e.g., "Very frequent" = 3).
Time Frame
Month 6
Title
Conners Rating Scale
Description
Conners: a questionnaire that asks about things like behavior, work or schoolwork, and social life. The Conners-3 Parent Rating Scale (Conners-3-P) is the most recent revision to a widely used behavior rating scale system. The Conners-3-P includes 5 empirically derived scales: Hyperactivity/Impulsivity, Executive Functioning, Learning Problems, Aggression, and Peer Relations.Respondents are asked to rate behavior that has been problematic over the preceding month using a four-point Likert scale labeled with both levels of appropriateness (e.g., "Not true at all" = 0), and frequency (e.g., "Very frequent" = 3).
Time Frame
Month 9
Secondary Outcome Measure Information:
Title
Tower of London Test
Description
Tower of London Test : is used to assess executive functions, particularly the future implications of one's action
Time Frame
T0 (BASELINE) - T1 (SIX MONTHS) - T2 (NINE MONTHS)
Title
Nepsy- II
Description
Nepsy battery assess a whole range of general attentional and executive functions, such as the ability to inhibit learned automatic responses, to monitor and self-regulate one's own behaviors and responses, selective and sustained attention (vigilance), the ability to understand, generate, maintain, or change a set of response rules, non-verbal problem-solving skills, and the ability to plan and organize complex responses
Time Frame
T0 (BASELINE) - T1 (SIX MONTHS) - T2 (NINE MONTHS)
Title
Parenting Styles Questionnaire
Description
This questionnaire assesses the types of parental styles by presenting a list of qualities and behaviors referred to situations of interaction with the child. Answers are collected using a Likert-scale 5-point, from never (=1) to always (=5). Parenting style is measured by calculating as an average over the items related to each style.
Time Frame
T0 (BASELINE) - T1 (SIX MONTHS) - T2 (NINE MONTHS)
Title
Child behavior Checklist
Description
Child behavior Checklist assesses emotional and behavioral problems in children
Time Frame
T0 (BASELINE) - T1 (SIX MONTHS) - T2 (NINE MONTHS)
Title
Test of Multidimensional self-esteem
Description
TMA is gets an accurate measurement of self-esteem in developmental age a 150-items self-report questionnaire. It's made up of six subscales: interpersonal relationships, environmental control competence, emotionality, scholastic success, family life, body perception. Participants have to express their agreement with each item according to the following response options: absolutely true, true, false, absolutely false.
Time Frame
T0 (BASELINE) - T1 (SIX MONTHS) - T2 (NINE MONTHS)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adriana Piccolo, Psy
Phone
09060128257
Email
adriana.piccolo@irccsme.it
Facility Information:
Facility Name
IRCCS Centro Neurolesi Bonino Pulejo
City
Messina
ZIP/Postal Code
98100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bioparco delle intelligenze e delle neuro-fragilità
Phone
09060128256
Email
info@irccsme.it

12. IPD Sharing Statement

Citations:
PubMed Identifier
25369623
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.
Results Reference
background
PubMed Identifier
21258430
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.
Results Reference
background
PubMed Identifier
22168816
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.
Results Reference
background
PubMed Identifier
25632280
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.
Results Reference
background
PubMed Identifier
30704545
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.
Results Reference
background
PubMed Identifier
18559885
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.
Results Reference
background
PubMed Identifier
31837729
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.
Results Reference
background
PubMed Identifier
22161373
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.
Results Reference
background
PubMed Identifier
29234356
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.
Results Reference
background
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.
Results Reference
background

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Virtual Reality for Parent Training Intervention

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