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Effectiveness of Family-Professional Collaboration on Functional Goals Achievement of Children With Cerebral Palsy and Caregivers' Quality of Life and Burden

Primary Purpose

Cerebral Palsy, Collaborative Intervention Process, Functional Goals Achievement

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
family-professional collaboration practice model
Sponsored by
King Saud University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Cerebral Palsy focused on measuring Family-professional collaboration, partnerships, children's performance, quality of life, burden, caregivers, physical therapists

Eligibility Criteria

2 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Physical therapists with at least one year of experience in pediatric physical therapy. Children with CP, aged between 2 to 12 years, Gross Motor Function Classification System (GMFCS) level I, II, and III, and attended the physical therapy sessions accompanied by their caregivers. Exclusion Criteria: Physical therapists in the experimental group who rate their level of confidence to implement the collaborative strategies less than 4 out of 5. children who underwent recent surgery (6 months) or after Botulinum toxin injection treatment (3 months), had uncontrolled seizure disorder, or discontinued physical therapy sessions.

Sites / Locations

  • King Saud University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

family-professional collaboration practice model

conventional therapy

Arm Description

Physical therapists in the family-professional collaboration practice model group will receive instructions in the collaborative intervention, following the process and the strategies of the family-professional collaboration practice model to enhance the collaboration during physical therapy sessions. The instruction conducted online in two sessions for six hours (3 hours per session). the therapists in this group will treat the children according to steps of family-professional collaboration practice model: Step 1: Mutually agreed-upon goals, Step 2: shared planning, Step 3:Shared implementation, and Step 4: Shared evaluation of child and family outcomes.

Physical therapists in the conventional therapy group will not receive any instructions related to the collaborative intervention process. the therapists in this group will treat the children as conventional therapy

Outcomes

Primary Outcome Measures

Goals Attainments Scale (assessing change of the goals achievement from base line data)
Goals Attainments Scale (GAS) is a standardized scoring procedure to assess goal achievement and quantifies meaningful change. GAS consists of a 5-point Likert scale where (-2) is the lowest score at the baseline level, (-1) mean progression toward the goals but not reached (0) representing the expected level after the intervention (+1) showed better level than expected (+2) is the highest score which means the best possible level.
World health organization quality of life- Brief assessing change of the quality of life from base line data)
It is a self-report questionnaire focus on measuring the respondents' perception of the last two weeks before administration. The four domains of QOL that are identified by WHO were assess as following; physical health (7 items); psychological health (6 items); social relationships (3 items), and environment (8 items). These items scored on a five-point Likert scale ranging from (1) mean strongly agree to (5) mean strongly disagree.
Zarit Burden Interview- Arabic Abridged version assessing change of the burden from base line data)
The Zarit Burden Interview- Arabic Abridged version (ZBI-A) was used to measure caregiver burden. It consists of 12 items rated on a 5-point Likert scale from (0) which represents never to (4) almost always. The total score ranged from 0 to 48, where a higher score demonstrates more sense of burden

Secondary Outcome Measures

Full Information

First Posted
January 2, 2023
Last Updated
January 29, 2023
Sponsor
King Saud University
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1. Study Identification

Unique Protocol Identification Number
NCT05709080
Brief Title
Effectiveness of Family-Professional Collaboration on Functional Goals Achievement of Children With Cerebral Palsy and Caregivers' Quality of Life and Burden
Official Title
Effectiveness of Family-Professional Collaboration on Functional Goals Achievement of Children With Cerebral Palsy and Caregivers' Quality of Life and Burden: A Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
November 30, 2021 (Actual)
Study Completion Date
November 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King Saud University

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 aim of this study is to examine the effect of implanting the family-professional collaboration practice model on the functional goals achievement of children with CP and their caregivers' quality of life and burden. The children will be treated by physical therapists who will be assigned to two groups (control and experimental).
Detailed Description
A randomized, single-blinded control study involved 28 physical therapists and 44 pairs of children with CP aged 2-12 years old and their caregivers will be assigned randomly into experimental and control groups. Physical therapists in the experimental group will receive two instructional sessions (3 hours each) to implement collaboration during the therapy sessions and physical therapists in the control group will receive no instructions. Children will receive 45- 60 minutes therapy sessions (5 sessions/week) for six weeks. Goal Attainment Scaling (GAS) to measure the children's goals achievement change rate, the Arabic version of the World Health Organization Quality of Life Brief (WHOQOL- Brief) to examine the caregivers' quality of life, and the Zarit Burden Interview Arabic Abridged version (ZBI-A) to evaluate the caregivers' burden will be used.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Collaborative Intervention Process, Functional Goals Achievement
Keywords
Family-professional collaboration, partnerships, children's performance, quality of life, burden, caregivers, physical therapists

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
family-professional collaboration practice model
Arm Type
Experimental
Arm Description
Physical therapists in the family-professional collaboration practice model group will receive instructions in the collaborative intervention, following the process and the strategies of the family-professional collaboration practice model to enhance the collaboration during physical therapy sessions. The instruction conducted online in two sessions for six hours (3 hours per session). the therapists in this group will treat the children according to steps of family-professional collaboration practice model: Step 1: Mutually agreed-upon goals, Step 2: shared planning, Step 3:Shared implementation, and Step 4: Shared evaluation of child and family outcomes.
Arm Title
conventional therapy
Arm Type
No Intervention
Arm Description
Physical therapists in the conventional therapy group will not receive any instructions related to the collaborative intervention process. the therapists in this group will treat the children as conventional therapy
Intervention Type
Other
Intervention Name(s)
family-professional collaboration practice model
Intervention Description
Online instructional sessions will be conducted in two sessions for six hours (3 hours per session) for the physical therapists in the experimental group. The instructional session focus on explaining the specific strategies and process to implement the Family-professional Collaboration (four step process) Model as ( Step 1: Mutually agreed-upon goals, Step 2: Shared planning, Step 3: Shared implementation and Step 4: Shared evaluation of child and family outcomes.
Primary Outcome Measure Information:
Title
Goals Attainments Scale (assessing change of the goals achievement from base line data)
Description
Goals Attainments Scale (GAS) is a standardized scoring procedure to assess goal achievement and quantifies meaningful change. GAS consists of a 5-point Likert scale where (-2) is the lowest score at the baseline level, (-1) mean progression toward the goals but not reached (0) representing the expected level after the intervention (+1) showed better level than expected (+2) is the highest score which means the best possible level.
Time Frame
the goals will be identified in the end of the first session( first week) , re-assessment session conducted on the beginning of the session (15) in the third week , and final assessment was conducted in the beginning of the session (30)in the sixth week
Title
World health organization quality of life- Brief assessing change of the quality of life from base line data)
Description
It is a self-report questionnaire focus on measuring the respondents' perception of the last two weeks before administration. The four domains of QOL that are identified by WHO were assess as following; physical health (7 items); psychological health (6 items); social relationships (3 items), and environment (8 items). These items scored on a five-point Likert scale ranging from (1) mean strongly agree to (5) mean strongly disagree.
Time Frame
the children's caregiver will fill the WHOQOL-Brief questionnaire twice, in the beginning of the first session in the first week and at end of the session (30) last sessionsin the sixth week
Title
Zarit Burden Interview- Arabic Abridged version assessing change of the burden from base line data)
Description
The Zarit Burden Interview- Arabic Abridged version (ZBI-A) was used to measure caregiver burden. It consists of 12 items rated on a 5-point Likert scale from (0) which represents never to (4) almost always. The total score ranged from 0 to 48, where a higher score demonstrates more sense of burden
Time Frame
the children's caregiver will fill the ZBI-A questionnaire twice, in the beginning of the first session in the first week and at end of the session (30) last session in the sixth week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Physical therapists with at least one year of experience in pediatric physical therapy. Children with CP, aged between 2 to 12 years, Gross Motor Function Classification System (GMFCS) level I, II, and III, and attended the physical therapy sessions accompanied by their caregivers. Exclusion Criteria: Physical therapists in the experimental group who rate their level of confidence to implement the collaborative strategies less than 4 out of 5. children who underwent recent surgery (6 months) or after Botulinum toxin injection treatment (3 months), had uncontrolled seizure disorder, or discontinued physical therapy sessions.
Facility Information:
Facility Name
King Saud University
City
Riyadh
Country
Saudi Arabia

12. IPD Sharing Statement

Learn more about this trial

Effectiveness of Family-Professional Collaboration on Functional Goals Achievement of Children With Cerebral Palsy and Caregivers' Quality of Life and Burden

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