Clinical trial NCT04935593: Strengthening Social, Emotional and Behavioral Resilience
Official title: Strengthening Social, Emotional and Behavioral Resilience: The RENEW (Resilience in Emotional and Behavioral Wellbeing) Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neurodevelopmental Disorders
Emotional Disorder
Behavior Disorders
Keywords: Social and emotional learning
Social return on investment
Gamification
Behavioral and Emotional Disorders
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2021-06-23
Enrollment: 60
Sex: ALL
Minimum age (years): 8
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* Home Internet access

Exclusion Criteria:

* No parental consent
* Sensory challenges to electronic devices

Primary outcomes:
measure: Change from baseline in social-emotional competence on the Devereux Student Strengths Assessment - Mini instrument
timeFrame: Baseline and Week 10
measure: Change from baseline in Self-Management assessment score on the Self-Management knowledge assessment form
timeFrame: Baseline and Week 6
measure: Change from baseline in Self-Awareness assessment score on the Self-Awareness knowledge assessment form
timeFrame: Baseline and Week 6
measure: Change from baseline in Social-Awareness assessment score on the social-awareness knowledge assessment form
timeFrame: Baseline and Week 8
measure: Change from baseline in Relationships assessment score on the relationships knowledge assessment form
timeFrame: Baseline and Week 8
measure: Change from baseline in Decision-Making assessment score on the decision-making assessment form
timeFrame: Baseline and Week 10
Secondary outcomes:
measure: Change from baseline in Global self-concept score on the Social Emotional Assets and Resilience Scale - Child Short Form
timeFrame: Baseline to Week 10
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: Taipei Adventist American School
state: Shilin
Study officials:
affiliation: Taipei Medical University
name: Usman Iqbal, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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