Social VR Based Intervention on Enhancing Social Interaction Skills in Children With AD/HD

NCT05568446 | Unknown

• 1 other identifier: HSEARS20220823001
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study targets children with diagnosed ADHD and aims to (1) develop a social virtual reality based (SocVR) intervention and (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. The study will be a three-arm parallel randomised controlled trial comparing the effects of a SocVR with traditional social skills training on social skills and executive functioning of children with ADHD. The study period is 2 months, including 4 weeks (2 sessions per week) of intervention and control, followed by a 4-week follow-up. The participants will be assessed at three time points (i.e. at baseline, 4 weeks and 4 weeks follow-up). The guidelines of Whitehead et al. (2016) suggested that recommended that at least 16 subjects per group for medium effect size in pilot RCT and 15% attrition over time can be expected. Thus, the minimum sample size per group was 20. A total of 60 participants will be recruited in which 20 participants in the social VR group, 20 in the traditional social skills group and 20 in the waitlist control group.

Conditions

Attention-Deficit/Hyperactivity Disorder

Keywords

Attention-deficit/hyperactivity disorder; Virtual reality; Social interaction skills; Children

Outcome Measures

Primary Outcomes (3)

• Social Skills Rating Scale

  This scale consists of 3 subscales, including self-control, assertiveness and initiative, and cooperation, with a total of 31 items. A 3-point Likert scale (never, sometimes, often) is used to score.

  Baseline

• Social Skills Rating Scale

  This scale consists of 3 subscales, including self-control, assertiveness and initiative, and cooperation, with a total of 31 items. A 3-point Likert scale (never, sometimes, often) is used to score.

  Change from baseline social skills at week 4 post-interventioin

• Social Skills Rating Scale

  This scale consists of 3 subscales, including self-control, assertiveness and initiative, and cooperation, with a total of 31 items. A 3-point Likert scale (never, sometimes, often) is used to score.

  Week 8 follow-up

Secondary Outcomes (3)

• Behavior Rating Inventory of Executive Function

  Baseline

• Behavior Rating Inventory of Executive Function

  Change from baseline social skills at week 4 post-interventioin

• Behavior Rating Inventory of Executive Function

  Week 8 follow-up

Other Outcomes (1)

• Simulator Sickness Questionnaire

  Week 4 post-interventioin

Study Arms (3)

Social VR group

EXPERIMENTAL

Social VR (SocVR) intervention is developed to enhance the social interaction skills of children. The participants will wear a head-mounted display (HMD) for the SocVR intervention. Each session of the SocVR intervention lasts for a maximum of 20 minutes to ensure the participants focus on the intervention and prevent causing any physical effect (Yamaguchi, 1999). The intervention contains three real-life virtual scenarios, including (1) classroom and playground, (2) MTR station and compartment, and (3) street and building. One scenario will be adopted in each session. The sequences of the scenarios used in each session will be the same for all participants. During the SocVR intervention, one RA will also appear as one avatar in the scenario to guide the participants to complete a series of tasks. Each intervention session will be conducted in a classroom independently for each participant.

Behavioral: Social virtual reality

Traditional social skills group

ACTIVE COMPARATOR

An experienced special educational needs (SEN) teacher will teach the participants social interaction skills through tradidactic instructions and role-play activities. Four modules will be covered in the 4-week training: (1) how to introduce yourself and basic social skills; (2) how to listen to others; (3) how to share with others; (4) learn to know how people feel and how to empathise. These modules have been applied in many studies (Braswell \& Bloomquist, 1991; Huang et al., 2015). The content of this training will be as similar as possible to the SocVR training. The training lasts 20 minutes which depends on the emotion of the participants. Each training session will be conducted in a classroom independently for each participant.

Behavioral: Traditional social skills

Waitlist control group

NO INTERVENTION

With reference to Beck et al. (2010), the participants in this group will receive no training and they can participate in the social VR training after the intervention period. To ensure the consistency of the experiment, the participants are not allowed to initiate or change their pharmacological treatment during the 8-week intervention period.

Interventions

Social virtual reality BEHAVIORAL

The participants will receive eight training sessions in 4 weeks (2 sessions per week). Each session is about 20 minutes.

Social VR group

Traditional social skills BEHAVIORAL

The participants will receive eight training sessions in 4 weeks (2 sessions per week). Each session is about 20 minutes.

Traditional social skills group

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Aged between 6 and 12 years
• Ethnic Chinese
• Residing in Hong Kong
• Having received a diagnosis of ADHD by Child Assessment Service in Hong Kong or via private practice
• Stable on pharmacological and/or psychological treatment for ADHD 8 weeks before baseline (determined by health care professionals on the basis of medication data and behavioural observation)
• No initiation or change of pharmacological treatment for ADHD during the intervention period ability to read Chinese, and speak and listen to Cantonese by the child and by at least one of their parents or legal guardian
• Willing to provide informed consent by both participants and one of their parents or legal guardian

You may not qualify if:

• Comorbid autism
• Mental retardation
• An estimated IQ lower than 85 (using the Wechsler Intelligence Scale for Children - Fourth Edition (Hong Kong) (WISC-IV(HK)))
• Autism spectrum disorder (previously diagnosed by health care professionals)
• Comorbid acute psychiatric disorder (previously diagnosed by health care professionals)
• With a severe physical disability (e.g., blindness, deafness) or learning disability (e.g., dyslexia).

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Ka Po Wong, PhD

  School of Nursing, The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ka Po Wong, PhD

CONTACT

64860214; portia.wong@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 30, 2022
• First Posted: October 5, 2022
• Study Start: November 15, 2022
• Primary Completion: February 28, 2023
• Study Completion: March 31, 2023
• Last Updated: October 5, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: The data will be available after the completion of the study writing.
• Access Criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).