Virtual Reality for Parent Training Intervention

IRCCS Centro Neurolesi "Bonino-Pulejo"

Status: Enrolling

Conditions: Attention-Deficit/Hyperactivity Disorder (ADHD)

Treatments: Behavioral: Parent training; Behavioral: Virtual Reality-assisted PT sessions

Study type: Interventional

Funder types: Other

Identifiers

NCT05809388

PT22

Details and patient eligibility

About

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.

Full 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.

Enrollment: 68 estimated patients

Sex: All

Ages: 6 to 10 years old

Volunteers: No 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

68 participants in 2 patient groups

Experimental Group (EG)

Experimental group

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.

Treatment:

Behavioral: Virtual Reality-assisted PT sessions

Behavioral: Parent training

Control Group (CG)

Active Comparator group

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.

Treatment:

Behavioral: Parent training