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

NCT ID: NCT05709080

Last Updated: 2023-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2021-11-30

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.

Conditions

Cerebral Palsy; Collaborative Intervention Process; Functional Goals Achievement

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

family-professional collaboration practice model

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.

Group Type: EXPERIMENTAL

family-professional collaboration practice model

Intervention Type: OTHER

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.

conventional therapy

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

family-professional collaboration practice model

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

King Saud University

OTHER

Sponsor Role: lead

Responsible Party

Sarah Alotaibi

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

King Saud University

Riyadh, , Saudi Arabia

Countries

Saudi Arabia

Other Identifiers

IRB No.: 36-2020-IRB

Identifier Type: -

Identifier Source: org_study_id