Cerebral PalsyNCT05709080
Effectiveness of Family-Professional Collaboration on Functional Goals Achievement of Children With Cerebral Palsy and Caregivers' Quality of Life and Burden
A study testing family-professional collaboration practice model in people with Cerebral Palsy and Collaborative Intervention Process, run by King Saud University at 1 site in Saudi Arabia.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Cerebral Palsy, Collaborative Intervention Process, Functional Goals Achievement
- What is being tested?
- family-professional collaboration practice model
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Dec 2020to 30 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read the 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.
- Being tested
- family-professional collaboration practice model
- Keywords
- Family-professional collaboration, partnerships, children's performance, quality of life, burden, caregivers, physical therapists
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
family-professional collaboration practice modelOther
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.
| Study group | Role | What they receive |
|---|---|---|
| family-professional collaboration practice model | Experimental | 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. Receives: Other: family-professional collaboration practice model |
| conventional therapy | No intervention | 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2023
- Study start1 Dec 2020
- Primary completion30 Nov 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Alotaibi, King Saud University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05709080
- Sponsor's protocol ID
- IRB No.: 36-2020-IRB
- Status last verified
- Jan 2023
- First submitted
- 2 Jan 2023
- Last updated
- 1 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05709080
- Acronym / sponsor ID
- IRB No.: 36-2020-IRB
- Keywords
- Family-professional collaboration, partnerships, children's performance, quality of life, burden, caregivers, physical therapists
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 1 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| family-professional collaboration practice model | Experimental | Other: family-professional collaboration practice modelPhysical 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. |
| conventional therapy | No intervention | –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 |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| family-professional collaboration practice modelOnline 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. | Other | family-professional collaboration practice model |
Primary outcome
Goals Attainments Scale (assessing change of the goals achievement from base line data)
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
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)
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
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)
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing family-professional collaboration practice model in people with Cerebral Palsy and Collaborative Intervention Process, run by King Saud University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Goals Attainments Scale (assessing change of the goals achievement from base line data) (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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2023.