NCT04935593

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 4, 2021

Completed
19 days until next milestone

First Posted

Study publicly available on registry

June 23, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

September 7, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2022

Completed
Last Updated

March 24, 2022

Status Verified

June 1, 2021

Enrollment Period

7 months

First QC Date

June 4, 2021

Last Update Submit

March 23, 2022

Conditions

Keywords

Social and emotional learningSocial return on investmentGamificationBehavioral and Emotional Disorders

Outcome Measures

Primary Outcomes (6)

  • 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

    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

    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

    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

    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

    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

    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

    Baseline to Week 10

Study Arms (2)

Renew Intervention Group

EXPERIMENTAL

Participants in the group will receive training to help children strengthen social, emotional and behavioral knowledge and resilience.

Other: The RENEW Intervention

Parallel Control Group

NO INTERVENTION

Participants in the group will receive the usual bible lessons and activities

Interventions

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.

Also known as: The Resilience in Emotional and Behavioral Wellbeing (RENEW) Intervention
Renew Intervention Group

Eligibility Criteria

Age8 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Home Internet access

You may not qualify if:

  • No parental consent
  • Sensory challenges to electronic devices

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Adventist American School

Taipei, Shilin, 251, Taiwan

Location

Related Publications (8)

  • 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

    BACKGROUND
  • 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.

  • Fortune 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.

  • Ketcheson 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.

  • Maenner 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.

  • Price S. Addressing Autism: Giving Physicians Tools. Tex Med. 2019 Dec 1;115(12):42-44.

  • Wiggins 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.

  • Bowrin 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.

MeSH Terms

Conditions

Neurodevelopmental DisordersMental DisordersBehavior

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Usman Iqbal, PhD

    Taipei Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2021

First Posted

June 23, 2021

Study Start

September 7, 2021

Primary Completion

March 30, 2022

Study Completion

March 30, 2022

Last Updated

March 24, 2022

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations