Last reviewed · How we verify
Social Virtual-reality on Enhancing Social Interaction Skills in Children With Attention-deficit/Hyperactivity Disorder
NA trial testing Virtual reality in Virtual Reality in 90 participants. Completed in 6 September 2024.
| Lead sponsor | The Hong Kong Polytechnic University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | health services research |
| Enrollment | 90 |
| Start date | 18 February 2023 |
| Primary completion | 31 August 2024 |
| Estimated completion | 6 September 2024 |
| Sites | 1 location across Hong Kong |
The Hong Kong Polytechnic University
Adults 6 to 12, any sex, with Virtual Reality or Social Interaction. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The attendance of the participants during the trainings will be recorded. To verify the validity of the findings, training non-adherence of the participants will be terminated which will be stated in the consent form. The absence of any training session will be considered as non-adherence.
| Group | Value | 95% CI |
|---|---|---|
| Social VR Intervention | 100 | |
| Traditional Social Skills Training | 96.6 | |
| Waitlist Control Group | 63.3 |
This assessment utilizes the Riggio Social Skills Inventory to objectively evaluate participants' social interaction skills. The total score ranges from 10 to 40, where higher scores indicate better social interaction skills. The inventory consists of 10 items, each scored on a scale from 1 (Never) to 4 (Always). Scores for each item are summed to compute a total score, with higher total scores representing better outcomes in social interaction skills. The inventory includes subscales that measure aspects of verbal and non-verbal communication.
| Group | Value | 95% CI |
|---|---|---|
| Social VR Intervention | 38.20 | ± 2.83 |
| Traditional Social Skills Training | 30.63 | ± 6.57 |
| Waitlist Control Group | 24.50 | ± 5.17 |
This assessment evaluates participants' self-control, assertiveness, and initiative and cooperation. The SSRS-P consists of 3 subscales with a total of 31 items. A 3-point Likert scale (1 = Never, 2 = Sometimes, 3 = Often) is used for scoring. The total score ranges from 31 to 93, where higher scores indicate better social skills. Scores for each subscale are summed, contributing to the total score. The SSRS-P is a validated instrument commonly adopted in clinical trials of psychiatric and neurological disorders.
| Group | Value | 95% CI |
|---|---|---|
| Social VR Intervention | 33.33 | ± 3.56 |
| Traditional Social Skills Training | 31.93 | ± 2.78 |
| Waitlist Control Group | 31.50 | ± 4.70 |
To assess the executive functioning of participants using the Behavior Rating Inventory of Executive Function (BRIEF), which will be scored by the participants' guardians. The subscales of inhibition (16 items) and emotional control (10 items) will be adopted in this study. A 3-point Likert scale (1 = Never, 2 = Sometimes, 3 = Often) is used to score. The total score ranges from 26 to 78, with higher scores indicating poor executive functions.
| Group | Value | 95% CI |
|---|---|---|
| Social VR Intervention | 16.83 | ± 3.08 |
| Traditional Social Skills Training | 17.98 | ± 2.68 |
| Waitlist Control Group | 19.63 | ± 4.91 |
Satisfaction with the intervention was measured using a 7-point Likert scale (1 = very dissatisfied, 7 = very satisfied) administered at the last session of the VR training group. The total score ranges from 1 to 7, with higher scores indicating greater satisfaction.
| Group | Value | 95% CI |
|---|---|---|
| Social VR Intervention | 6.8 | ± 1.6 |
| Traditional Social Skills Training | 6.7 | ± 1.7 |
To measure the motion sickness or physical discomfort of participants in VR environment. Nine items will be measured, including discomfort, fatigue, headache, eyestrain, sweating, nausea, difficulty concentrating, blurred vision and dizziness, with yes or no questions for each item.
| Group | Value | 95% CI |
|---|---|---|
| Social VR Intervention | 0 | |
| Traditional Social Skills Training | 0 | |
| Waitlist Control Group | 0 |
The study targets children with diagnosed ADHD and aims to (1) develop a social virtual reality-based intervention, (2) investigate its effects on improving the social skills and executive functioning of inhibitions, emotional control and attention of the children compared to traditional social skills training and (3) evaluate the subjects acceptability and compliance with social VR training for enhancing social interaction skills. It is hypothesised that the social interaction skills of the participants in the social VR training group are likely to perform better than those in the traditional social skills training group. Participants in the waitlist control group will receive no change in social interaction skills compared with the two intervention groups.
2 peer-reviewed publications reference this trial (live from Europe PMC):
Verify or expand the search:
Trials testing the same drug.
Currently open trials in the same condition.
Trials by the same sponsor.
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05778526.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing