Clinical trial NCT05564871: Effectiveness of Occupational Therapy Teleintervention in Pediatric
Official title: The Effectiveness of Occupational Therapy Teleintervention for Children Aged 5-8 With Neurodevelopmental Disorders.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Telerehabilitation
Neurodevelopmental Disorders
Keywords: Telemedicine, NDD's, Occupational Therapy
Lead sponsor: Hebrew University of Jerusalem
Sponsor class: OTHER
First posted: 2022-10-04
Enrollment: 40
Sex: ALL
Minimum age (years): 5
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The high prevalence of children with neurodevelopmental disorders (NDD's; 5-29%) combined with the low accessibility and availability of child development services in Israel raises an urgent need to develop innovative, effective and accessible models of intervention. Teleintervention is an innovative and practical option for providing developmental services, however the evidence for its effectiveness among this population are insufficient. Study goals are: (1) to adapt an occupation therapy intervention for remote delivery; (2) to assess its feasibility (in terms of adherence, treatment fidelity and satisfaction with care); (3) to assess its efficacy in promoting personal functional goals, participation in daily activities and QOL in children aged 5-8 years with NDD's. We will conduct a controlled study without randomization using mixed methods. Participants will include 40 children with NDD's and functional difficulties in daily life that will assigned to study group (teleintervention; n=20) or control group (in person intervention; n=20). The intervention program will include 12 weekly sessions based on an evidence-based approach (CO-OP), that will take place in videoconference or in personal meetings formats. The main outcome measures will include standard assessment tools aim to assess participation and QOL. Feasibility will be assessed in terms of adherence, fidelity and satisfaction with care using a descriptive statistics and feedback interviews. Effectiveness will be evaluated by group X time interaction using a repeated measure MANOVA. To examine the variables that predict adherence and success in treatment, linear regression will be used. In addition, a thematic analysis of the qualitative information will be performed.

Detailed description: Background and aims: The high prevalence of children with neurodevelopmental disorders (NDD's; 5-29%) combined with the low accessibility and availability of child development services in the south region of Israel raises an urgent need to develop innovative, effective and accessible models of intervention. Teleintervention is an innovative and practical option for providing developmental services for people who are in their home, however the evidence for its effectiveness among this population are insufficient. Study goals are: (1) to adapt an occupation therapy intervention for remote delivery; (2) to assess its feasibility (in terms of adherence, treatment fidelity and satisfaction with care); (3) to assess its efficacy in promoting personal functional goals, participation in daily activities and QOL in children aged 5-8 years with NDD's. Methods: We will conduct a controlled study without randomization using mixed methods. Participants will include 40 children with NDD's and functional difficulties in daily life that will assigned to study group (teleintervention; n=20) or control group (in person intervention; n=20). Participants will be recruited from the child development unites at "Meuhedet" HMO in the southern district. The intervention program will include 12 weekly sessions based on an evidence-based approach (CO-OP), that will take place in videoconference or in personal meetings formats. The purpose of the intervention model is to improve personal goals that will be defined by each child and his/her parents. The main outcome measures will include standard assessment tools aim to assess participation and QOL. Participants will undergo baseline and post-intervention assessments. Feasibility will be assessed in terms of adherence, fidelity and satisfaction with care using a descriptive statistics and feedback interviews. Effectiveness will be evaluated by group X time interaction using a repeated measure MANOVA. To examine the variables that predict adherence and success in treatment, linear regression will be used. In addition, a thematic analysis of the qualitative information will be performed. Preliminary results from a pilot study (N= 14) conducted during the COVID-19 pandemic and military escalation demonstrated the feasibility of occupation therapy teleintervention. The results also suggest the protentional efficacy of the program, thus a clinically significant improvement was achieved in 80% / 73.68% of the personal goals practiced during the treatment according to the child and parent report (respectively). Expected results: the results of the study could constitute a theoretical and practical infrastructure for the establishment of occupational therapy teleintervention services in addition to face-to-face services that currently exist exclusively, for the large population of children with NDD's and to allow immediate implementation of the intervention program as part of the child development services in Israel. Importance to Medicine: This innovative, cost-effective format will improve accessibility to occupational therapy services for children with NDD's and their families in the peripheral regions of Israel. In the long run, it can be assumed that the integration of accessible and effective services in child development units will help reduce the burden on their families, promote their functioning and reduce the need for medical and social assistance services in the future.

Eligibility criteria: Inclusion Criteria:

* Hebrew at mother tongue level
* Child's ability to identify at least three functional difficulties for the purpose of setting treatment goals
* Availability of computer with web camera and an IPad connected to broadband or Wi-Fi in their home

Exclusion Criteria:

* Children with somatic or physical disabilities, children diagnosed with ASD, following a brain injury or children with mental health disorders.

Primary outcomes:
measure: Canadian Occupational Performance Measure - COPM (Law et al., 2017)
timeFrame: Change from baseline occupational performance at 6 months
measure: Performance Quality Rating Scale - PQRS (Miller et al., 2001)
timeFrame: Change from baseline performance quality at 6 months
measure: The Child and Adolescent Scale of Participation (CASP; Bedell, 2004).
timeFrame: Change from baseline participation at 6 months
measure: Pediatric Quality of Life Inventory (PedsQL; Varni & Limbers, 2009).
timeFrame: Change from baseline quality of life at 6 months
Secondary outcomes:
measure: Socio-Demographic and Clinical Characteristics
timeFrame: 1 year (before the intervention)
measure: Feasibility Therapist Log Book
timeFrame: 1-2 years (during the intervention)
measure: Parents as Partners in Intervention- Satisfaction Questionnaire - PAPI- Q (Hirsch, Waldman-Levy and Parush, 2005)
timeFrame: 2 years (after the intervention)
measure: Qualitative feedback interview
timeFrame: 2 years (after the intervention)
Other outcomes:
Locations:
Study officials:
affiliation: Hebrew University of Jerusalem
name: Yafit Gilboa, PhD
role: STUDY_DIRECTOR
References: