Virtual Reality for Parent Training Intervention

Study Overview
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Brief Summary
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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
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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.

Official Title
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Implementation of Parent Training Through the Use of Virtual Reality: a Randomized, Controlled, Single-blind Study

Conditions
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Attention-Deficit/Hyperactivity Disorder (ADHD)

Intervention / Treatment
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* Behavioral: Parent training
* Behavioral: Virtual Reality-assisted PT sessions


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group (EG)<br>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. | Behavioral: Parent training<br>* 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.<br>Behavioral: Virtual Reality-assisted PT sessions<br>* 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.<br>|
| Active Comparator: Control Group (CG)<br>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. | Behavioral: Parent training<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline | 
| 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. | Month 6 | 
| 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. | Month 9 | 
| 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. | Baseline | 
| 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. | Month 6 | 
| 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. | Month 9 | 
| 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). | Baseline | 
| 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). | Month 6 | 
| 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). | Month 9 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tower of London Test | Tower of London Test : is used to assess executive functions, particularly the future implications of one's action | T0 (BASELINE) - T1 (SIX MONTHS) - T2 (NINE MONTHS) | 
| 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 | T0 (BASELINE) - T1 (SIX MONTHS) - T2 (NINE MONTHS) | 
| 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. | T0 (BASELINE) - T1 (SIX MONTHS) - T2 (NINE MONTHS) | 
| Child behavior Checklist | Child behavior Checklist assesses emotional and behavioral problems in children | T0 (BASELINE) - T1 (SIX MONTHS) - T2 (NINE MONTHS) | 
| 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. | T0 (BASELINE) - T1 (SIX MONTHS) - T2 (NINE MONTHS) |