Implementation of Parent Training Through the Use of Virtual Reality: a Randomized, Controlled, Single-blind Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 68
- Locations
- 1
- Primary Endpoint
- Parenting Stress Index
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 6 Years to 10 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Control Group (CG)
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: Parent training (Behavioral)
Experimental Group (EG)
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.
Intervention: Parent training (Behavioral)
Experimental Group (EG)
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.
Intervention: Virtual Reality-assisted PT sessions (Behavioral)
Outcomes
Primary Outcomes
Parenting Stress Index
Time Frame: Month 9
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
Time Frame: Month 9
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
Time Frame: Month 9
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).
Parenting Stress Index
Time Frame: Baseline
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
Time Frame: Month 6
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
Time Frame: Baseline
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
Time Frame: Month 6
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
Time Frame: Baseline
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
Time Frame: Month 6
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 Outcomes
- Tower of London Test(T0 (BASELINE) - T1 (SIX MONTHS) - T2 (NINE MONTHS))
- Parenting Styles Questionnaire(T0 (BASELINE) - T1 (SIX MONTHS) - T2 (NINE MONTHS))
- Nepsy- II(T0 (BASELINE) - T1 (SIX MONTHS) - T2 (NINE MONTHS))
- Child behavior Checklist(T0 (BASELINE) - T1 (SIX MONTHS) - T2 (NINE MONTHS))
- Test of Multidimensional self-esteem(T0 (BASELINE) - T1 (SIX MONTHS) - T2 (NINE MONTHS))
Investigators
Adriana Piccolo
Principal Investigator
IRCCS Centro Neurolesi "Bonino-Pulejo"