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Effectiveness of Occupational Therapy Teleintervention in Pediatric

Primary Purpose

Telerehabilitation, Neurodevelopmental Disorders

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
occupation-based teleintervention
Sponsored by
Hebrew University of Jerusalem
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Telerehabilitation focused on measuring Telemedicine, NDD's, Occupational Therapy

Eligibility Criteria

5 Years - 9 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Occupation-based teleintervention

    Occupation-based in person intervention

    Arm Description

    20 children and their parents will be participate in Occupation-based teleintervention.

    20 children and their parents will be participate in Occupation-based in person intervention.

    Outcomes

    Primary Outcome Measures

    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).
    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)
    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 (α = 0.96).
    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).

    Secondary Outcome Measures

    Socio-Demographic and Clinical Characteristics
    Demographic and medical details will be collected from the patients' personal medical records.
    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)
    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 (α = 0.80), suggesting that the items were inter-related and related to the scale as a whole.
    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.

    Full Information

    First Posted
    September 14, 2022
    Last Updated
    September 29, 2022
    Sponsor
    Hebrew University of Jerusalem
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05564871
    Brief Title
    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

    2. Study Status

    Record Verification Date
    September 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2022 (Anticipated)
    Primary Completion Date
    June 2024 (Anticipated)
    Study Completion Date
    June 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hebrew University of Jerusalem

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Telerehabilitation, Neurodevelopmental Disorders
    Keywords
    Telemedicine, NDD's, Occupational Therapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Occupation-based teleintervention
    Arm Type
    Experimental
    Arm Description
    20 children and their parents will be participate in Occupation-based teleintervention.
    Arm Title
    Occupation-based in person intervention
    Arm Type
    Experimental
    Arm Description
    20 children and their parents will be participate in Occupation-based in person intervention.
    Intervention Type
    Other
    Intervention Name(s)
    occupation-based teleintervention
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Canadian Occupational Performance Measure - COPM (Law et al., 2017)
    Description
    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).
    Time Frame
    Change from baseline occupational performance at 6 months
    Title
    Performance Quality Rating Scale - PQRS (Miller et al., 2001)
    Description
    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)
    Time Frame
    Change from baseline performance quality at 6 months
    Title
    The Child and Adolescent Scale of Participation (CASP; Bedell, 2004).
    Description
    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 (α = 0.96).
    Time Frame
    Change from baseline participation at 6 months
    Title
    Pediatric Quality of Life Inventory (PedsQL; Varni & Limbers, 2009).
    Description
    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).
    Time Frame
    Change from baseline quality of life at 6 months
    Secondary Outcome Measure Information:
    Title
    Socio-Demographic and Clinical Characteristics
    Description
    Demographic and medical details will be collected from the patients' personal medical records.
    Time Frame
    1 year (before the intervention)
    Title
    Feasibility Therapist Log Book
    Description
    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)
    Time Frame
    1-2 years (during the intervention)
    Title
    Parents as Partners in Intervention- Satisfaction Questionnaire - PAPI- Q (Hirsch, Waldman-Levy and Parush, 2005)
    Description
    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 (α = 0.80), suggesting that the items were inter-related and related to the scale as a whole.
    Time Frame
    2 years (after the intervention)
    Title
    Qualitative feedback interview
    Description
    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.
    Time Frame
    2 years (after the intervention)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    5 Years
    Maximum Age & Unit of Time
    9 Years
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Stav Ben-Zagmi, MsC
    Phone
    0526513215
    Email
    stav.benzagni@mail.huji.ac.il
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yafit Gilboa, PhD
    Organizational Affiliation
    Hebrew University of Jerusalem
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    all IPD that underlie results in a publication
    IPD Sharing Time Frame
    study protocol - 1 year SAP, ICF, CSR - 3-3.5 years the data will be available until the end of the research
    IPD Sharing Access Criteria
    anonyms PDF's or outputs of the statistical analysis by SPSS. the information will be sent by personal requests consider the purpose and relevant to the current research.

    Learn more about this trial

    Effectiveness of Occupational Therapy Teleintervention in Pediatric

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