Neurodevelopmental DisordersNCT04935593
Strengthening Social, Emotional and Behavioral Resilience
A study testing The RENEW Intervention in people with Neurodevelopmental Disorders and Emotional Disorder, run by Taipei Medical University at 1 site in Taiwan.
Trial summary
Behavioral and emotional disorders adversely affect overall health and well-being. Prevalence rates among children and adolescents classified with behavioral and emotional disorders or neurodevelopmental disorders (NDD), as recently redefined in ICD-11, have steadily increased over the past decade. Read more about this study
- Who is it for?
- Ages 8 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Neurodevelopmental Disorders, Emotional Disorder, Behavior Disorders
- What is being tested?
- The RENEW Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 7 Sep 2021to 30 Mar 2022
- 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 8 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Home Internet access
Who cannot join
- No parental consent
- Sensory challenges to electronic devices
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Strengthening Social, Emotional and Behavioral Resilience: The RENEW (Resilience in Emotional and Behavioral Wellbeing) Pilot Randomized Controlled Trial
Behavioral and emotional disorders adversely affect overall health and well-being. Prevalence rates among children and adolescents classified with behavioral and emotional disorders or neurodevelopmental disorders (NDD), as recently redefined in ICD-11, have steadily increased over the past decade. In particular, prevalence rates among persons classified with Autism Spectrum Disorders (ASD), the fastest rising behavioral and emotional disorder, have sharply risen over the past five years and is now estimated at 1 in 54. Shared symptoms within behavioral and emotional disorders include persistent social, emotional and behavioral functioning deficits that often impact self-management, social-awareness and metacognition competences, in addition to adulthood health and wellness life course transition management.
Social and Emotional Learning (SEL) stakeholder advocates have contributed meaningfully to the strengthening of behavioral and emotional health through interventions that focus primarily on physical and mental health outcomes of diagnosed individuals. However, focus on spiritual health outcomes and the at-risk population remain largely underutilized. Research that seeks to employ an integrative physical-mental-spiritual approach to strengthen social, emotional and behavioral resilience, of at-risk school age populations where social stigma and prohibitive treatment costs remain barriers to treatment is needed to help expand the field's understanding of the reciprocal relationship between spiritual health and emotional and behavioral outcomes.
The RENEW (Resilience in Emotional and Behavioral Wellbeing) intervention will employ a multidisciplinary approach of social and emotional learning competency training, gamification principles and faith-centered values to strengthen social, behavioral and emotional resilience and competencies of those at risk for behavioral and emotional disorders, via a child-as co-researcher approach.
Read the detailed description
Emotional and Behavior Disorders (EBD) or neurodevelopmental disorders (NDD) as recently redefined are a collection of behavioral and cognitive disorder classifications that describe a spectrum of deficits in social functioning, metacognition and self-management competencies, in particular, among children and adolescence. The subcategories of NDDs as listed in World Health Organization's 11th edition of the International Statistical Classification of Diseases and Related Health Problems (ICD) include Autism Spectrum Disorder (ASD), Attention-Deficit Hyperactivity Disorder (ADHD), Development of Learning Disorder and Disorders of Intellectual Development.
Prevalence rates among children and adolescents classified with EBDs or NDDs have steadily increased over the past decade. Autism Spectrum Disorders (ASD) or Autism Spectrum Conditions (ASC) is the fastest growing NDD affecting approximately one percent (1%) of the world's population. Prevalence rates among persons diagnosed with Autism Spectrum Conditions (ASC) have steadily risen over the past decade and are now estimated at 1 in 54. Autism's spectrum of social, emotional and behavioral impairments often range in severity and impact poor adulthood outcomes, primarily in health and wellness life course trajectories, of the unclassified. Shared symptoms within EBDs/NDDs include persistent social and behavioral functioning deficits that often impact self-management, social-awareness and metacognition competences, in addition to adulthood health and wellness life course transition management.
According to the World Health Organization (WHO), there are three main ways to classify health interventions, namely by target (the entity on which the action is carried out), action (a deed done by an actor to a target), or means (the process and methods by which the action is carried out). Empirical research has identified currently available social and emotional learning (SEL) interventions that target the clinically diagnosed. However, an issue with such interventions is that they provide no support to at-risk and/or undiagnosed behavioral and emotional disorder (EBD) vulnerable populations. The SEL intervention literature has also documented available psychosocial actions to support EBD children and young persons, such as cognitive behavioral therapy (CBT) and executive functioning skills training. However, a vulnerability of these actions is that they are often secular or void of a spiritual, religious or personal belief dimension to effect meaningful transformation as well as not participatory of EBD youth in the research process. Lastly, the SEL intervention literature has illuminated evidence on the available means/methods to support or deliver actions to EBD youth, such as via commercial-off-the-shelf (COTS) software, virtual reality (VR) technologies, games and robot-based platforms. However, a drawback of such means or methods is that they are often cost prohibitive, not conducive to facilitating citizen development and lacking in gamification features to strengthen end user engagement. Thus, there is a need to supplement the existing SEL intervention literature with programs that support spiritual health outcomes of at-risk EBD youth in a manner that fosters co-researcher opportunities and generates a social return on investment.
In this paper, we describe a protocol for a pilot evaluation of a faith-centered, non-medical, gamification assisted intervention, dubbed RENEW (Resilience in Emotional and Behavioral Wellbeing), an innovative, culturally appropriate, cost effective and participatory program developed to identify and strengthen social emotional behavioral resilience among primary and middle age school children populations who are increasingly exhibiting social emotional behavior symptoms. The research is situated at the intersection of technology, spirituality and global health practice in effort to strengthen contributions to health and wellness outputs, outcomes and impacts. The research endeavor will employ a multidisciplinary blend of gamification principles, co-researcher participation and faith-centered values to strengthen social, behavioral and emotional resilience competencies in effort to enhance social and behavioral deficit management.
- Being tested
- The RENEW Intervention
- Keywords
- Social and emotional learning, Social return on investment, Gamification, Behavioral and Emotional Disorders
- Medical subject headings
- Neurodevelopmental Disorders, Mental Disorders, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The RENEW InterventionOther
Also called The Resilience in Emotional and Behavioral Wellbeing (RENEW) Intervention
An game-based intervention that will provide lessons and activities in social-awareness, self-management, self-awareness, relationships and decision making in effort to strengthen social, emotional and behavioral competence. The intervention will be administered tri-weekly for 20 minutes each session.
| Study group | Role | What they receive |
|---|---|---|
| Renew Intervention Group | Experimental | Participants in the group will receive training to help children strengthen social, emotional and behavioral knowledge and resilience. Receives: Other: The RENEW Intervention |
| Parallel Control Group | No intervention | Participants in the group will receive the usual bible lessons and activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in social-emotional competence on the Devereux Student Strengths Assessment - Mini instrument
The Devereux Student Strengths Assessment - Mini is a 8-point brief version of the Devereux Student Strengths Assessment intended to serve as a universal screener of social and emotional competencies
Rating Scale:
(Never = 0; Rarely = 1; Occasionally = 2; Frequently = 3; Very Frequently = 4)
High scores indicate a proficiency in social-emotional competence Low scores indicate need for instruction in social-emotional competence
Measured: Baseline and Week 10
Change from baseline in Self-Management assessment score on the Self-Management knowledge assessment form
The Self-Management assessment is a 10-question quiz designed to assess a participants knowledge of self-management
Rating Scale:
(Need for knowledge of self-management < 60); (Average knowledge of self-management >= 60 and < 80); (Knowledge Proficiency of self-management >= 80)
High scores indicate a proficiency in self-management knowledge Low scores indicate need for instruction in self-management knowledge
Measured: Baseline and Week 6
Change from baseline in Self-Awareness assessment score on the Self-Awareness knowledge assessment form
The Self-Awareness assessment is a 10-question quiz designed to assess a participants knowledge of self-awareness
Rating Scale:
(Need for knowledge of self-awareness < 60); (Average knowledge of self-awareness >= 60 and < 80); (Knowledge Proficiency of self-awareness >= 80)
High scores indicate a proficiency in self-awareness knowledge Low scores indicate need for instruction in self-awareness knowledge
Measured: Baseline and Week 6
Change from baseline in Social-Awareness assessment score on the social-awareness knowledge assessment form
The Social-Awareness assessment is a 10-question quiz designed to assess a participants knowledge of social-awareness
Rating Scale:
(Need for knowledge of social-awareness < 60); (Average knowledge of social-awareness >= 60 and < 80); (Knowledge Proficiency of social-awareness >= 80)
High scores indicate a proficiency in social-awareness knowledge Low scores indicate need for instruction in social-awareness knowledge
Measured: Baseline and Week 8
Change from baseline in Relationships assessment score on the relationships knowledge assessment form
The Relationships assessment is a 10-question quiz designed to assess a participants knowledge of relationships
Rating Scale:
(Need for knowledge of relationships < 60); (Average knowledge of relationships >= 60 and < 80); (Knowledge Proficiency of relationships >= 80)
High scores indicate a proficiency in relationship knowledge Low scores indicate need for instruction in relationship knowledge
Measured: Baseline and Week 8
Change from baseline in Decision-Making assessment score on the decision-making assessment form
The Decision-Making assessment is a 10-question quiz designed to assess a participants knowledge of decision-making
Rating Scale:
(Need for knowledge of decision-making < 60); (Average knowledge of decision-making >= 60 and < 80); (Knowledge Proficiency of decision-making >= 80)
High scores indicate a proficiency in decision-making knowledge Low scores indicate need for instruction in decision-making knowledge
Measured: Baseline and Week 10
Secondary outcomes (1)
Change from baseline in Global self-concept score on the Social Emotional Assets and Resilience Scale - Child Short Form
The Social Emotional Assets and Resilience Scale - Child Short form is a 12-question, self-report measure of a child's perception of his or her own global self-concept score.
Rating Scale:
(Never = 1; Sometimes = 2; Often = 3; Always = 4)
High scores indicate adequacy in self-concept perception Low scores indicate inadequacy in self-concept perception
Measured: Baseline to Week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study start7 Sep 2021
- Primary completion30 Mar 2022 (estimated)
- Study completion30 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Neurodevelopmental DisordersStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Usman Iqbal, PhD, Principal investigator, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04935593
- Sponsor's protocol ID
- pbowrin001
- Status last verified
- Jun 2021
- First submitted
- 4 Jun 2021
- Last updated
- 24 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Garwood, J. D., Peltier, C., Sinclair, T., Eisel, H., McKenna, J. W., & Vannest, K. J. (2020). A Quantitative Synthesis of Intervention Research Published in Flagship EBD Journals: 2010 to 2019. Behavioral Disorders. https://doi.org/10.1177/0198742920961341
Bitta M, Kariuki SM, Abubakar A, Newton CRJC. Burden of neurodevelopmental disorders in low and middle-income countries: A systematic review and meta-analysis. Wellcome Open Res. 2017 Dec 29;2:121. doi: 10.12688/wellcomeopenres.13540.3. eCollection 2017.
PubMed 29881784Fortune N, Madden R, Riley T, Short S. The International Classification of Health Interventions: an 'epistemic hub' for use in public health. Health Promot Int. 2021 Dec 23;36(6):1753-1764. doi: 10.1093/heapro/daab011.
PubMed 33585880Ketcheson L, Hauck JL, Ulrich D. The levels of physical activity and motor skills in young children with and without autism spectrum disorder, aged 2-5 years. Autism. 2018 May;22(4):414-423. doi: 10.1177/1362361316683889. Epub 2017 Mar 1.
PubMed 29152992Maenner MJ, Shaw KA, Baio J; EdS1; Washington A, Patrick M, DiRienzo M, Christensen DL, Wiggins LD, Pettygrove S, Andrews JG, Lopez M, Hudson A, Baroud T, Schwenk Y, White T, Rosenberg CR, Lee LC, Harrington RA, Huston M, Hewitt A; PhD-7; Esler A, Hall-Lande J, Poynter JN, Hallas-Muchow L, Constantino JN, Fitzgerald RT, Zahorodny W, Shenouda J, Daniels JL, Warren Z, Vehorn A, Salinas A, Durkin MS, Dietz PM. Prevalence of Autism Spectrum Disorder Among Children Aged 8 Years - Autism and Developmental Disabilities Monitoring Network, 11 Sites, United States, 2016. MMWR Surveill Summ. 2020 Mar 27;69(4):1-12. doi: 10.15585/mmwr.ss6904a1.
PubMed 32214087Price S. Addressing Autism: Giving Physicians Tools. Tex Med. 2019 Dec 1;115(12):42-44.
PubMed 31800089Wiggins LD, Durkin M, Esler A, Lee LC, Zahorodny W, Rice C, Yeargin-Allsopp M, Dowling NF, Hall-Lande J, Morrier MJ, Christensen D, Shenouda J, Baio J. Disparities in Documented Diagnoses of Autism Spectrum Disorder Based on Demographic, Individual, and Service Factors. Autism Res. 2020 Mar;13(3):464-473. doi: 10.1002/aur.2255. Epub 2019 Dec 23.
PubMed 31868321Bowrin P, Bowrin E, Iqbal U, Sanna M. Benefits of RENEW: A Faith-Infused, Game-Based Social-Emotional Intervention: Evidence from a Pilot Cluster Randomized Crossover Trial on Primary School Children in Taiwan. J Relig Health. 2025 Jun;64(3):1594-1606. doi: 10.1007/s10943-024-02224-z. Epub 2024 Dec 24.
PubMed 39719545
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strengthening Social, Emotional and Behavioral Resilience: The RENEW (Resilience in Emotional and Behavioral Wellbeing) Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04935593
- Acronym / sponsor ID
- pbowrin001
- Keywords
- Social and emotional learning, Social return on investment, Gamification, Behavioral and Emotional Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 7 Sep 2021 (actual)
- Primary completion
- 30 Mar 2022 (estimated)
- Study completion
- 30 Mar 2022 (estimated)
- First posted
- 23 Jun 2021 (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.
Behavioral and emotional disorders adversely affect overall health and well-being. Prevalence rates among children and adolescents classified with behavioral and emotional disorders or neurodevelopmental disorders (NDD), as recently redefined in ICD-11, have steadily increased over the past decade. In particular, prevalence rates among persons classified with Autism Spectrum Disorders (ASD), the fastest rising behavioral and emotional disorder, have sharply risen over the past five years and is now estimated at 1 in 54. Shared symptoms within behavioral and emotional disorders include persistent social, emotional and behavioral functioning deficits that often impact self-management, social-awareness and metacognition competences, in addition to adulthood health and wellness life course transition management.
Social and Emotional Learning (SEL) stakeholder advocates have contributed meaningfully to the strengthening of behavioral and emotional health through interventions that focus primarily on physical and mental health outcomes of diagnosed individuals. However, focus on spiritual health outcomes and the at-risk population remain largely underutilized. Research that seeks to employ an integrative physical-mental-spiritual approach to strengthen social, emotional and behavioral resilience, of at-risk school age populations where social stigma and prohibitive treatment costs remain barriers to treatment is needed to help expand the field's understanding of the reciprocal relationship between spiritual health and emotional and behavioral outcomes.
The RENEW (Resilience in Emotional and Behavioral Wellbeing) intervention will employ a multidisciplinary approach of social and emotional learning competency training, gamification principles and faith-centered values to strengthen social, behavioral and emotional resilience and competencies of those at risk for behavioral and emotional disorders, via a child-as co-researcher approach.
Detailed description
Emotional and Behavior Disorders (EBD) or neurodevelopmental disorders (NDD) as recently redefined are a collection of behavioral and cognitive disorder classifications that describe a spectrum of deficits in social functioning, metacognition and self-management competencies, in particular, among children and adolescence. The subcategories of NDDs as listed in World Health Organization's 11th edition of the International Statistical Classification of Diseases and Related Health Problems (ICD) include Autism Spectrum Disorder (ASD), Attention-Deficit Hyperactivity Disorder (ADHD), Development of Learning Disorder and Disorders of Intellectual Development.
Prevalence rates among children and adolescents classified with EBDs or NDDs have steadily increased over the past decade. Autism Spectrum Disorders (ASD) or Autism Spectrum Conditions (ASC) is the fastest growing NDD affecting approximately one percent (1%) of the world's population. Prevalence rates among persons diagnosed with Autism Spectrum Conditions (ASC) have steadily risen over the past decade and are now estimated at 1 in 54. Autism's spectrum of social, emotional and behavioral impairments often range in severity and impact poor adulthood outcomes, primarily in health and wellness life course trajectories, of the unclassified. Shared symptoms within EBDs/NDDs include persistent social and behavioral functioning deficits that often impact self-management, social-awareness and metacognition competences, in addition to adulthood health and wellness life course transition management.
According to the World Health Organization (WHO), there are three main ways to classify health interventions, namely by target (the entity on which the action is carried out), action (a deed done by an actor to a target), or means (the process and methods by which the action is carried out). Empirical research has identified currently available social and emotional learning (SEL) interventions that target the clinically diagnosed. However, an issue with such interventions is that they provide no support to at-risk and/or undiagnosed behavioral and emotional disorder (EBD) vulnerable populations. The SEL intervention literature has also documented available psychosocial actions to support EBD children and young persons, such as cognitive behavioral therapy (CBT) and executive functioning skills training. However, a vulnerability of these actions is that they are often secular or void of a spiritual, religious or personal belief dimension to effect meaningful transformation as well as not participatory of EBD youth in the research process. Lastly, the SEL intervention literature has illuminated evidence on the available means/methods to support or deliver actions to EBD youth, such as via commercial-off-the-shelf (COTS) software, virtual reality (VR) technologies, games and robot-based platforms. However, a drawback of such means or methods is that they are often cost prohibitive, not conducive to facilitating citizen development and lacking in gamification features to strengthen end user engagement. Thus, there is a need to supplement the existing SEL intervention literature with programs that support spiritual health outcomes of at-risk EBD youth in a manner that fosters co-researcher opportunities and generates a social return on investment.
In this paper, we describe a protocol for a pilot evaluation of a faith-centered, non-medical, gamification assisted intervention, dubbed RENEW (Resilience in Emotional and Behavioral Wellbeing), an innovative, culturally appropriate, cost effective and participatory program developed to identify and strengthen social emotional behavioral resilience among primary and middle age school children populations who are increasingly exhibiting social emotional behavior symptoms. The research is situated at the intersection of technology, spirituality and global health practice in effort to strengthen contributions to health and wellness outputs, outcomes and impacts. The research endeavor will employ a multidisciplinary blend of gamification principles, co-researcher participation and faith-centered values to strengthen social, behavioral and emotional resilience competencies in effort to enhance social and behavioral deficit management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Renew Intervention Group | Experimental | Other: The RENEW InterventionParticipants in the group will receive training to help children strengthen social, emotional and behavioral knowledge and resilience. |
| Parallel Control Group | No intervention | –Participants in the group will receive the usual bible lessons and activities |
Who may qualify
- Ages
- 8 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Home Internet access
Key exclusion criteria (2 listed)
- No parental consent
- Sensory challenges to electronic devices
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 |
|---|---|---|
| The RENEW InterventionAlso: The Resilience in Emotional and Behavioral Wellbeing (RENEW) InterventionAn game-based intervention that will provide lessons and activities in social-awareness, self-management, self-awareness, relationships and decision making in effort to strengthen social, emotional and behavioral competence. The intervention will be administered tri-weekly for 20 minutes each session. | Other | Renew Intervention Group |
Primary outcome
Change from baseline in social-emotional competence on the Devereux Student Strengths Assessment - Mini instrument
Time frame: Baseline and Week 10
The Devereux Student Strengths Assessment - Mini is a 8-point brief version of the Devereux Student Strengths Assessment intended to serve as a universal screener of social and emotional competencies Rating Scale: (Never = 0; Rarely = 1; Occasionally = 2; Frequently = 3; Very Frequently = 4) High scores indicate a proficiency in social-emotional competence Low scores indicate need for instruction in social-emotional competence
Change from baseline in Self-Management assessment score on the Self-Management knowledge assessment form
Time frame: Baseline and Week 6
The Self-Management assessment is a 10-question quiz designed to assess a participants knowledge of self-management Rating Scale: (Need for knowledge of self-management < 60); (Average knowledge of self-management >= 60 and < 80); (Knowledge Proficiency of self-management >= 80) High scores indicate a proficiency in self-management knowledge Low scores indicate need for instruction in self-management knowledge
Change from baseline in Self-Awareness assessment score on the Self-Awareness knowledge assessment form
Time frame: Baseline and Week 6
The Self-Awareness assessment is a 10-question quiz designed to assess a participants knowledge of self-awareness Rating Scale: (Need for knowledge of self-awareness < 60); (Average knowledge of self-awareness >= 60 and < 80); (Knowledge Proficiency of self-awareness >= 80) High scores indicate a proficiency in self-awareness knowledge Low scores indicate need for instruction in self-awareness knowledge
Change from baseline in Social-Awareness assessment score on the social-awareness knowledge assessment form
Time frame: Baseline and Week 8
The Social-Awareness assessment is a 10-question quiz designed to assess a participants knowledge of social-awareness Rating Scale: (Need for knowledge of social-awareness < 60); (Average knowledge of social-awareness >= 60 and < 80); (Knowledge Proficiency of social-awareness >= 80) High scores indicate a proficiency in social-awareness knowledge Low scores indicate need for instruction in social-awareness knowledge
Change from baseline in Relationships assessment score on the relationships knowledge assessment form
Time frame: Baseline and Week 8
The Relationships assessment is a 10-question quiz designed to assess a participants knowledge of relationships Rating Scale: (Need for knowledge of relationships < 60); (Average knowledge of relationships >= 60 and < 80); (Knowledge Proficiency of relationships >= 80) High scores indicate a proficiency in relationship knowledge Low scores indicate need for instruction in relationship knowledge
Change from baseline in Decision-Making assessment score on the decision-making assessment form
Time frame: Baseline and Week 10
The Decision-Making assessment is a 10-question quiz designed to assess a participants knowledge of decision-making Rating Scale: (Need for knowledge of decision-making < 60); (Average knowledge of decision-making >= 60 and < 80); (Knowledge Proficiency of decision-making >= 80) High scores indicate a proficiency in decision-making knowledge Low scores indicate need for instruction in decision-making knowledge
1 secondary outcome
Change from baseline in Global self-concept score on the Social Emotional Assets and Resilience Scale - Child Short Form
Time frame: Baseline to Week 10
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2022.
- BackgroundGarwood, J. D., Peltier, C., Sinclair, T., Eisel, H., McKenna, J. W., & Vannest, K. J. (2020). A Quantitative Synthesis of Intervention Research Published in Flagship EBD Journals: 2010 to 2019. Behavioral Disorders. https://doi.org/10.1177/0198742920961341
- Results publication: PubMed 29881784Bitta M, Kariuki SM, Abubakar A, Newton CRJC. Burden of neurodevelopmental disorders in low and middle-income countries: A systematic review and meta-analysis. Wellcome Open Res. 2017 Dec 29;2:121. doi: 10.12688/wellcomeopenres.13540.3. eCollection 2017.
- Results publication: PubMed 33585880Fortune N, Madden R, Riley T, Short S. The International Classification of Health Interventions: an 'epistemic hub' for use in public health. Health Promot Int. 2021 Dec 23;36(6):1753-1764. doi: 10.1093/heapro/daab011.
- Results publication: PubMed 29152992Ketcheson L, Hauck JL, Ulrich D. The levels of physical activity and motor skills in young children with and without autism spectrum disorder, aged 2-5 years. Autism. 2018 May;22(4):414-423. doi: 10.1177/1362361316683889. Epub 2017 Mar 1.
- Results publication: PubMed 32214087Maenner MJ, Shaw KA, Baio J; EdS1; Washington A, Patrick M, DiRienzo M, Christensen DL, Wiggins LD, Pettygrove S, Andrews JG, Lopez M, Hudson A, Baroud T, Schwenk Y, White T, Rosenberg CR, Lee LC, Harrington RA, Huston M, Hewitt A; PhD-7; Esler A, Hall-Lande J, Poynter JN, Hallas-Muchow L, Constantino JN, Fitzgerald RT, Zahorodny W, Shenouda J, Daniels JL, Warren Z, Vehorn A, Salinas A, Durkin MS, Dietz PM. Prevalence of Autism Spectrum Disorder Among Children Aged 8 Years - Autism and Developmental Disabilities Monitoring Network, 11 Sites, United States, 2016. MMWR Surveill Summ. 2020 Mar 27;69(4):1-12. doi: 10.15585/mmwr.ss6904a1.
- Results publication: PubMed 31800089Price S. Addressing Autism: Giving Physicians Tools. Tex Med. 2019 Dec 1;115(12):42-44.
- Results publication: PubMed 31868321Wiggins LD, Durkin M, Esler A, Lee LC, Zahorodny W, Rice C, Yeargin-Allsopp M, Dowling NF, Hall-Lande J, Morrier MJ, Christensen D, Shenouda J, Baio J. Disparities in Documented Diagnoses of Autism Spectrum Disorder Based on Demographic, Individual, and Service Factors. Autism Res. 2020 Mar;13(3):464-473. doi: 10.1002/aur.2255. Epub 2019 Dec 23.
- Derived from this study: PubMed 39719545Bowrin P, Bowrin E, Iqbal U, Sanna M. Benefits of RENEW: A Faith-Infused, Game-Based Social-Emotional Intervention: Evidence from a Pilot Cluster Randomized Crossover Trial on Primary School Children in Taiwan. J Relig Health. 2025 Jun;64(3):1594-1606. doi: 10.1007/s10943-024-02224-z. Epub 2024 Dec 24.
- Individual participant dataSharing planned: No
Related trials for Neurodevelopmental Disorders
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
RecruitingPhase 1
Cannabidiol (CBD) in Adults With ASD
Autism Spectrum Disorder
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
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.
Usman Iqbal, PhD principal investigator
Taipei Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The RENEW Intervention in people with Neurodevelopmental Disorders and Emotional Disorder, run by Taipei Medical University at 1 site in Taiwan.
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 1 inclusion and 2 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 Mar 2022. 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 Taiwan. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in social-emotional competence on the Devereux Student Strengths Assessment - Mini instrument (time frame: Baseline and Week 10). The study lists 6 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 NCT04935593, which also lists 8 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 Mar 2022.