The Effectiveness of Telehealth-Based Family-Centered Early Intervention

NCT06615895 | Active Not Recruiting DMC

• 2 other identifiers: TMU-JIRB N202407062113HCP-04
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Children with developmental delays or sensory processing disorders (SPD) face challenges in processing and integrating sensory information from their environment, which can lead to behavioral, learning, and social issues. Visual-vestibular stimulation activities target fundamental abilities such as balance, coordination, and sensory processing, which are crucial for many developmental areas. Past literature supports the use of digital media as a medium to provide ongoing home-based occupational therapy interventions for children who are unable to receive in-person treatment, with opportunities for caregiver-guided interventions. Therefore, this project is designed based on the \"1001 Children\'s Therapy Activities\" model as the foundation for behavioral intervention, combining parent and child participation in play to establish effective home activities and execution, aiming to enhance children\'s visual perception and posture-movement performance, thereby improving learning outcomes. Objective: To investigate the impact of a \"Telehealth Visual and Vestibular Home Program\" that integrates parent and child activity participation on children\'s visual perceptual performance and posture-movement effects. Method: Caregivers of children attending early intervention clinics at a teaching hospital in northern Taiwan are recruited and randomly assigned to either a remote group (N=30) or a waitlist group (N=30). The remote group receives a 6-week visual and vestibular home course; the waitlist group will participate after a 6-week. Assessments using the Developmental Test of Visual Perception (DTVP-2), the Movement Assessment Battery for Children, Second Edition (MABC-2), and a course satisfaction questionnaire are conducted before and after the intervention. Data Analysis: Basic data are presented using descriptive statistics, and t tests are used to compare pre- and post-training assessment mean values. Statistical analysis is performed using SPSS 26.0, with a significance level set at Alpha\<0.05.

Conditions

Children Receiving Early Intervention; Visual Perception Performance; Effects of Posture and Movement

Keywords

sensory processing disorders; Telehealth-health; Family-Centered

Outcome Measures

Primary Outcomes (1)

• Children's sensory integration function assessment scale (preschool version)

  In order to diagnose children with abnormal sensory integration in Taiwan, it covers seven dimensions of disorders and the phenomenon of sensory unintegration, with a total of 98 questions: posture and movement, integrated movement sequence on both sides, sensory discrimination, sensory adjustment, sensory search, and attention. and activity level, emotional/behavioral reactions, using a five-point scale. The higher the score, the worse the sensory integration, that is, the more obvious the disorder characteristics are. The test-retest reliability of each subscale is between .82 and .94; internal Consistency reliability ranges from .80 to .94

  before and after the intervention, study completion, an average of 6 weeks

Secondary Outcomes (4)

• Developmental Test of Visual Perception (DTVP-2)

  before and after the intervention, study completion, an average of 6 weeks

• Movement Assessment Battery for Children for Children, Second Edition ( MABC-2)

  before and after the intervention, study completion, an average of 6 weeks

• the number of adverse reactions and side effects

  After the intervention, study completion, an average of 6 weeks

• Course satisfaction questionnaire

  After the intervention, study completion, an average of 6 weeks

Study Arms (2)

Telehealth group

EXPERIMENTAL

An online video course for 6 weeks. The therapist will provide online video courses 3-5 times a week and record the implementation on the online platform every week. The course includes action plans, two Lateral integration/cross-midline, vestibular system, visual perception, opto-motor integration, eye movements, core strength activities and balance ability, etc.

Behavioral: Telehealth home activity

Waiting group

NO INTERVENTION

The "waiting group" was provided with an explanation of the objectives of the course. After the objectives of the study were explained in the first course, they waited for 6 weeks before receiving remote intervention.

Interventions

Telehealth home activity BEHAVIORAL

Several course activities with diverse sensory modalities are provided a week. Caregivers or caretakers need to help children participate in the course content and implement relevant suggestions at least 3-5 times a week for six weeks. The research will be conducted on an online platform. Course announcements, reminders and confirmation of work execution, through caregivers\' feedback records, urge caregivers to engage in parent-child games related to sensory integration and integrated into life at home. Such high-frequency, short-term sensory activities will be adapted to the equipment available at home. It will mainly focus on movement planning, bilateral integration/crossing the midline, vestibular system , visual perception, visual-motor integration, eye movements, core strength activities and Activities focused on balance ability.

Telehealth group

Eligibility Criteria

• Age: 3 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• (1) Children currently receiving early treatment; (2) Children with caregivers who need to establish a home treatment plan; (3) Children who can cooperate with the trial process and complete homework at home, and have completed at least 5/6 of the training; (4) There is an Internet connection;

You may not qualify if:

• (1) Children\'s medical records show a diagnosis of central nervous system injury (such as cerebral palsy, brain trauma, epilepsy, cortical blindness), rare disease diagnosis (such as William\'s disease, Down syndrome); (2) Children under 3 years old , 7 years old and above; (3) The caregiver cannot communicate in Chinese.

Sponsors & Collaborators

• Taipei Medical University Shuang Ho Hospital: lead

Study Sites (1)

Taipei Medical University Shuang Ho Hospital

New Taipei City, 235, Taiwan

Location

Related Publications (9)

• Wiener-Vacher SR, Hamilton DA, Wiener SI. Vestibular activity and cognitive development in children: perspectives. Front Integr Neurosci. 2013 Dec 11;7:92. doi: 10.3389/fnint.2013.00092. eCollection 2013.

  PMID: 24376403 BACKGROUND

• Schoen SA, Lane SJ, Mailloux Z, May-Benson T, Parham LD, Smith Roley S, Schaaf RC. A systematic review of ayres sensory integration intervention for children with autism. Autism Res. 2019 Jan;12(1):6-19. doi: 10.1002/aur.2046. Epub 2018 Dec 12.

  PMID: 30548827 BACKGROUND

• Önal, G., Güney, G., Gün, F., & Huri, M. (2021). Telehealth in paediatric occupational therapy: a scoping review. International Journal of Therapy and Rehabilitation, 28(7), 1-16.

  BACKGROUND

• Moghadam, S. F., Haghgoo, H. A., Pishyareh, E., Bakhshi, E., Rezazadeh, N., Rostami, R., & Sadeghi, V. (2018). Vestibular therapy improved motor planning, attention, and balance in children with attention deficit hyperactivity disorders: a randomized controlled trial. Phys Med Rehabil Res, 3(2), 1-6.

  BACKGROUND

• Mikami M, Hirota T, Takahashi M, Adachi M, Saito M, Koeda S, Yoshida K, Sakamoto Y, Kato S, Nakamura K, Yamada J. Atypical Sensory Processing Profiles and Their Associations With Motor Problems In Preschoolers With Developmental Coordination Disorder. Child Psychiatry Hum Dev. 2021 Apr;52(2):311-320. doi: 10.1007/s10578-020-01013-5.

  PMID: 32529540 BACKGROUND

• Marino F, Chila P, Failla C, Crimi I, Minutoli R, Puglisi A, Arnao AA, Tartarisco G, Ruta L, Vagni D, Pioggia G. Tele-Assisted Behavioral Intervention for Families with Children with Autism Spectrum Disorders: A Randomized Control Trial. Brain Sci. 2020 Sep 18;10(9):649. doi: 10.3390/brainsci10090649.

  PMID: 32961875 BACKGROUND

• Hung Kn G, Fong KN. Effects of telerehabilitation in occupational therapy practice: A systematic review. Hong Kong J Occup Ther. 2019 Jun;32(1):3-21. doi: 10.1177/1569186119849119. Epub 2019 May 27.

  PMID: 31217758 BACKGROUND

• Huang CY, Huang TY, Koh CL, Yu YT, Chen KL. The Movement Assessment Battery for Children Second Edition in Ages 3 to 6 Years: A Cross-Cultural Comparison for Children in Taiwan. Phys Ther. 2024 Jan 1;104(1):pzad146. doi: 10.1093/ptj/pzad146.

  PMID: 37883453 BACKGROUND

• Blanche, E. I., Giuffrida, C., Hallway, M., Edwards, B., & Test, L. A. (2021). An Evidence-based Guide to Combining Interventions with Sensory Integration in Pediatric Practice. Routledge.

  BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessment tests are conducted before and after the intervention. The assessor is the same person, who is a single-blind and professionally trained therapist who does not know the group assignment of the case.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Subjects are assigned to the \"telehealth group\" or the \"waiting group\". The \"telehealth group\" participates in an online video course for 6 weeks. The therapist will provide online video courses 3-5 times a week and record the implementation on the online platform every week. The course includes action plans, two Lateral integration/cross-midline, vestibular system, visual perception, opto-motor integration, eye movements, core strength activities and balance ability, etc. The \"waiting group\" is to provide explanation of course objectives and wait for 6 weeks after explaining the objectives of this research in the first course.

Study Record Dates

• First Submitted: September 22, 2024
• First Posted: September 27, 2024
• Study Start: December 1, 2024
• Primary Completion: July 31, 2025
• Study Completion: August 31, 2025
• Last Updated: July 8, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)