Virtual Reality for Parent Training Intervention

NCT05809388 | Unknown

• 1 other identifier: PT22
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention-Deficit/Hyperactivity Disorder (ADHD)

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (5)

• Tower of London Test

  T0 (BASELINE) - T1 (SIX MONTHS) - T2 (NINE MONTHS)

• Nepsy- II

  T0 (BASELINE) - T1 (SIX MONTHS) - T2 (NINE MONTHS)

• Parenting Styles Questionnaire

  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)

Study Arms (2)

Experimental Group (EG)

EXPERIMENTAL

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; Behavioral: Virtual Reality-assisted PT sessions

Control Group (CG)

ACTIVE COMPARATOR

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

Interventions

Parent training BEHAVIORAL

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.

Control Group (CG); Experimental Group (EG)

Virtual Reality-assisted PT sessions BEHAVIORAL

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.

Experimental Group (EG)

Eligibility Criteria

• Age: 6 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS Centro Neurolesi Bonino Pulejo: lead

Study Sites (1)

IRCCS Centro Neurolesi Bonino Pulejo

Messina, 98100, Italy

RECRUITING

Related Publications (10)

• Felt BT, Biermann B, Christner JG, Kochhar P, Harrison RV. Diagnosis and management of ADHD in children. Am Fam Physician. 2014 Oct 1;90(7):456-64.

  PMID: 25369623 BACKGROUND

• Lange KW, Reichl S, Lange KM, Tucha L, Tucha O. The history of attention deficit hyperactivity disorder. Atten Defic Hyperact Disord. 2010 Dec;2(4):241-55. doi: 10.1007/s12402-010-0045-8. Epub 2010 Nov 30.

  PMID: 21258430 BACKGROUND

• Mulligan A, Anney R, Butler L, O'Regan M, Richardson T, Tulewicz EM, Fitzgerald M, Gill M. Home environment: association with hyperactivity/impulsivity in children with ADHD and their non-ADHD siblings. Child Care Health Dev. 2013 Mar;39(2):202-12. doi: 10.1111/j.1365-2214.2011.01345.x. Epub 2011 Dec 14.

  PMID: 22168816 BACKGROUND

• Hosainzadeh Maleki Z, Mashhadi A, Soltanifar A, Moharreri F, Ghanaei Ghamanabad A. Barkley's Parent Training Program, Working Memory Training and their Combination for Children with ADHD: Attention Deficit Hyperactivity Disorder. Iran J Psychiatry. 2014 Apr;9(2):47-54.

  PMID: 25632280 BACKGROUND

• Mulvihill A, Carroll A, Dux PE, Matthews N. Self-directed speech and self-regulation in childhood neurodevelopmental disorders: Current findings and future directions. Dev Psychopathol. 2020 Feb;32(1):205-217. doi: 10.1017/S0954579418001670.

  PMID: 30704545 BACKGROUND

• Modesto-Lowe V, Danforth JS, Brooks D. ADHD: does parenting style matter? Clin Pediatr (Phila). 2008 Nov;47(9):865-72. doi: 10.1177/0009922808319963. Epub 2008 Jun 16.

  PMID: 18559885 BACKGROUND

• Sibley MH, Graziano PA, Ortiz M, Rodriguez L, Coxe S. Academic impairment among high school students with ADHD: The role of motivation and goal-directed executive functions. J Sch Psychol. 2019 Dec;77:67-76. doi: 10.1016/j.jsp.2019.10.005. Epub 2019 Nov 22.

  PMID: 31837729 BACKGROUND

• Zwi M, Jones H, Thorgaard C, York A, Dennis JA. Parent training interventions for Attention Deficit Hyperactivity Disorder (ADHD) in children aged 5 to 18 years. Cochrane Database Syst Rev. 2011 Dec 7;2011(12):CD003018. doi: 10.1002/14651858.CD003018.pub3.

  PMID: 22161373 BACKGROUND

• Bashiri A, Ghazisaeedi M, Shahmoradi L. The opportunities of virtual reality in the rehabilitation of children with attention deficit hyperactivity disorder: a literature review. Korean J Pediatr. 2017 Nov;60(11):337-343. doi: 10.3345/kjp.2017.60.11.337. Epub 2017 Nov 27.

  PMID: 29234356 BACKGROUND

• Venuti, P., & Senese, V. P. (2007). Un questionario di autovalutazione degli stili parentali: Uno studio su un campione Italiano [A questionnaire of self parental styles: A study of an Italian sample]. Giornale Italiano di Psicologia, 34(3), 677-697.

  BACKGROUND

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Adriana Piccolo, Psy

CONTACT

09060128257; adriana.piccolo@irccsme.it

Study Design

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

Study Record Dates

• First Submitted: March 17, 2023
• First Posted: April 12, 2023
• Study Start: October 26, 2022
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: May 24, 2023

Record last verified: 2023-05

Locations

IT (1)