Effectiveness of Occupational Therapy Teleintervention in Pediatric

Neurodevelopmental Disorders Clinical Trial

Official title:

The Effectiveness of Occupational Therapy Teleintervention for Children Aged 5-8 With Neurodevelopmental Disorders.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05564871
• Other study ID #: HebrewHJ
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2022
• Est. completion date: June 2026

Study information

• Verified date: September 2022
• Source: Hebrew University of Jerusalem
• Contact: Stav Ben-Zagmi, MsC
• Phone: 0526513215
• Email: stav.benzagni[@]mail.huji.ac.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: June 2026
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 9 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neurodevelopmental Disorders
• Telerehabilitation

Intervention

Other:
• occupation-based teleintervention
Intervention protocol will include 12 weekly based on the principles of the CO-OP approach. The intervention will focus on solving problems in the participant's daily life and implementing strategies in accordance with the goals set according to the COPM (Law et al., 2017). In the research group, the intervention will be carried out through videoconference sessions between an occupational therapist located at one of the child development units and the participant and their parents who are at home. The control group will receive a weekly session of CO-OP intervention in-person in one of the child development units.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hebrew University of Jerusalem

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Canadian Occupational Performance Measure - COPM (Law et al., 2017)	Hebrew version. The COPM is a widely used valid outcome measure in rehabilitation research, designed to measure the clients' self-perceptions of their activity performance and satisfaction with performance and detect changes over time. Participants in collaboration with the parents will be asked to identify goals and then rate their performance and satisfaction with performance on a scale of 1 to 10, where 10 indicates optimal performance or satisfaction. A minimal clinically significant difference is a 2-point change on the COPM performance ratings (Law et al., 2017).	Change from baseline occupational performance at 6 months
Primary	Performance Quality Rating Scale - PQRS (Miller et al., 2001)	is an observational measure of performance quality of client-selected, personally meaningful activities (therapeutic goals) originally developed for children with NDD's. The PQRS complements the COPM by assessing actual rather than perceived performances of the activities that were identified. The therapist will score each activity, using a 10-point performance rating scale between 1 (unable to perform) and 10 (performs well). The instrument is commonly used in studies involving intervention according to the CO-OP approach (Polatajko, 2017)	Change from baseline performance quality at 6 months
Primary	The Child and Adolescent Scale of Participation (CASP; Bedell, 2004).	The CASP assesses children's extent of participation and restrictions in home, school and community life situations and activities compared to same-age peers as reported by family caregivers. The CASP consist of 20 items divided into four sub-sections: (1) Home participation; (2) School participation; (3) Community participation; and (4) Home and community living activities. Each item addresses a broad participation domain with examples provided for each domain. The items are rated on a 4-point scale (4 = 'Age expected/full participation', 3 = 'Somewhat limited', 2 = 'Very limited',1 = 'Unable') or as "Not applicable". There are additional open-ended questions that identify additional supports and barriers to participation. Total scores range from 0-100, with higher scores indicating better participation. The CASP was found to be f reliable and valid, with high internal consistency (a = 0.96).	Change from baseline participation at 6 months
Primary	Pediatric Quality of Life Inventory (PedsQL; Varni & Limbers, 2009).	The PedsQL is used to assess health-related quality of life in children and adolescents (ages 2-18). The PedsQL consists of a 23-item in 4 domains: physical, emotional, social and school functioning. The items are rated on a 5-point scale (0 = 'Never'; 4 = 'Almost always') and linearly transformed to 0-100 scale, with higher scores indicating better health-related quality of life. The PedsQL was found to be a reliable and valid measure (high internal consistency, discriminates between groups such as children with and without a chronic condition, and responsive to change over time).	Change from baseline quality of life at 6 months
Secondary	Socio-Demographic and Clinical Characteristics	Demographic and medical details will be collected from the patients' personal medical records.	1 year (before the intervention)
Secondary	Feasibility Therapist Log Book	the occupational therapists who will conduct the intervention will write field notes following each session regarding the number, durations of the meetings performed, the number and reasons for cancellations cancelations. As well as the use of the key elements of the approach to ensure the implementation of the critical components of CO-OP, as described in the fidelity checklists (McEwen et al., 2012)	1-2 years (during the intervention)
Secondary	Parents as Partners in Intervention- Satisfaction Questionnaire - PAPI- Q (Hirsch, Waldman-Levy and Parush, 2005)	a structured questionnaire developed in Israel designed to assess (a) parental satisfaction and involvement with occupational therapy service, for example involvement in treatment procedure, sessions attendance and general satisfaction. In the present study will ask the parents to fulfill the questionnaire following the intervention. And (b) occupational therapist following the intervention aiming to assess the levels of cooperation and involvement of the child and his family throughout the treatment process. such as their presence, participation and implementation of the guidance provided. The questioners include 17 items rank on a 1-5 Likert scale, with a higher score indicating a higher level of satisfaction. Cronbach's alpha was good (a = 0.80), suggesting that the items were inter-related and related to the scale as a whole.	2 years (after the intervention)
Secondary	Qualitative feedback interview	a short structured interview will be conducted post intervention to obtain the parents' perception of the teleCO-OP intervention program. In the feedback interview, the parents will be asked three open-ended questions regarding a) their experience with the teleCO-OP intervention in general, b) the benefits or advantages, and c) disadvantages or barriers of this treatment method.	2 years (after the intervention)