Attention-Deficit/Hyperactivity Disorder (ADHD)NCT05809388
Virtual Reality for Parent Training Intervention
A study testing Parent training and Virtual Reality-assisted PT sessions in people with Attention-Deficit/Hyperactivity Disorder (ADHD), run by IRCCS Centro Neurolesi Bonino Pulejo at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 6 to 10 years
- Conditions the study is for
- Attention-Deficit/Hyperactivity Disorder (ADHD)
- What is being tested?
- Parent training and Virtual Reality-assisted PT sessions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteItaly
- Study dates
- 26 Oct 2022to 31 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Centro Neurolesi Bonino Pulejo
Messina, 98100
Bioparco delle intelligenze e delle neuro-fragilità, 09060128256, info@irccsme.it
About this study
Official title: Implementation of Parent Training Through the Use of Virtual Reality: a Randomized, Controlled, Single-blind Study
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.
Read the 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.
- Being tested
- Parent training, Virtual Reality-assisted PT sessions
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent trainingBehavioural
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.
Virtual Reality-assisted PT sessionsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Parent training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Month 9
Secondary outcomes (5)
Tower of London Test
Tower of London Test : is used to assess executive functions, particularly the future implications of one's action
Measured: T0 (BASELINE) - T1 (SIX MONTHS) - T2 (NINE MONTHS)
Nepsy- II
Nepsy battery assess a whole range of general attentional and executive functions, such as the ability to inhibit learned automatic responses, to monitor and self-regulate one's own behaviors and responses, selective and sustained attention (vigilance), the ability to understand, generate, maintain, or change a set of response rules, non-verbal problem-solving skills, and the ability to plan and organize complex responses
Measured: T0 (BASELINE) - T1 (SIX MONTHS) - T2 (NINE MONTHS)
Parenting Styles Questionnaire
This questionnaire assesses the types of parental styles by presenting a list of qualities and behaviors referred to situations of interaction with the child. Answers are collected using a Likert-scale 5-point, from never (=1) to always (=5). Parenting style is measured by calculating as an average over the items related to each style.
Measured: T0 (BASELINE) - T1 (SIX MONTHS) - T2 (NINE MONTHS)
Child behavior Checklist
Child behavior Checklist assesses emotional and behavioral problems in children
Measured: T0 (BASELINE) - T1 (SIX MONTHS) - T2 (NINE MONTHS)
Test of Multidimensional self-esteem
TMA is gets an accurate measurement of self-esteem in developmental age a 150-items self-report questionnaire. It's made up of six subscales: interpersonal relationships, environmental control competence, emotionality, scholastic success, family life, body perception. Participants have to express their agreement with each item according to the following response options: absolutely true, true, false, absolutely false.
Measured: T0 (BASELINE) - T1 (SIX MONTHS) - T2 (NINE MONTHS)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2023
- Study start26 Oct 2022
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Attention-Deficit/Hyperactivity Disorder (ADHD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Centro Neurolesi Bonino Pulejo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adriana Piccolo, IRCCS Centro Neurolesi Bonino Pulejo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05809388
- Sponsor's protocol ID
- PT22
- Status last verified
- May 2023
- First submitted
- 17 Mar 2023
- Last updated
- 24 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 25369623Lange 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.
PubMed 21258430Mulligan 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.
PubMed 22168816Hosainzadeh 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.
PubMed 25632280Mulvihill 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.
PubMed 30704545Modesto-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.
PubMed 18559885Sibley 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.
PubMed 31837729Zwi 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.
PubMed 22161373Bashiri 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.
PubMed 29234356Venuti, 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Parent Training Through the Use of Virtual Reality: a Randomized, Controlled, Single-blind Study
- ClinicalTrials.gov ID
- NCT05809388
- Acronym / sponsor ID
- PT22
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- IRCCS Centro Neurolesi Bonino PulejoUniversity, hospital or other
- Study start
- 26 Oct 2022 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 12 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group (EG) | Experimental | Behavioral: Parent training, Behavioral: Virtual Reality-assisted PT sessionsThe 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. |
| Control Group (CG) | Active comparator | Behavioral: Parent trainingThe 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. |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parent trainingParent 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. | Behavioural | Control Group (CG), Experimental Group (EG) |
| Virtual Reality-assisted PT sessionsThe 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. | Behavioural | Experimental Group (EG) |
Primary outcome
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.
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: 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.
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: 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).
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).
5 secondary outcomes
Tower of London Test
Time frame: T0 (BASELINE) - T1 (SIX MONTHS) - T2 (NINE MONTHS)
Nepsy- II
Time frame: T0 (BASELINE) - T1 (SIX MONTHS) - T2 (NINE MONTHS)
Parenting Styles Questionnaire
Time frame: T0 (BASELINE) - T1 (SIX MONTHS) - T2 (NINE MONTHS)
Child behavior Checklist
Time frame: T0 (BASELINE) - T1 (SIX MONTHS) - T2 (NINE MONTHS)
Test of Multidimensional self-esteem
Time frame: T0 (BASELINE) - T1 (SIX MONTHS) - T2 (NINE MONTHS)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2023.
- Background: PubMed 25369623Felt 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.
- Background: PubMed 21258430Lange 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.
- Background: PubMed 22168816Mulligan 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.
- Background: PubMed 25632280Hosainzadeh 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.
- Background: PubMed 30704545Mulvihill 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.
- Background: PubMed 18559885Modesto-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.
- Background: PubMed 31837729Sibley 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.
- Background: PubMed 22161373Zwi 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.
- Background: PubMed 29234356Bashiri 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.
- BackgroundVenuti, 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parent training and Virtual Reality-assisted PT sessions in people with Attention-Deficit/Hyperactivity Disorder (ADHD), run by IRCCS Centro Neurolesi Bonino Pulejo at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adriana Piccolo, Psy (09060128257, adriana.piccolo@irccsme.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parenting Stress Index (time frame: Baseline). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05809388, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2023.