Cerebral PalsyNCT05728593
The Effect of Parent-based Occupational Therapy
A study testing parent-based occupational therapy and Standard occupational therapy intervention in people with Cerebral Palsy and Parents, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Background/Aims Parents of children with cerebral palsy face higher levels of stress, anxiety and depression, sadness, exhaustion and burnout. Parent-based therapies have been found to increase parents' satisfaction with therapy, parent-child interactions and reduced parental stress. Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Cerebral Palsy, Parents
- What is being tested?
- parent-based occupational therapy and Standard occupational therapy intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2021to 1 Dec 2022
- 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 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- To be eligible for the study group, the following inclusion criteria had to be met:
- Children aged between 3 and 12 years who were diagnosed with cerebral palsy and their parents
- Willing to participate in the study
- Able to record videos
- Having the technological equipment to watch the video.
- To be eligible for the study group, the following inclusion criteria had to be met:
- Children aged between 3 and 12 years who were diagnosed with cerebral palsy and their parents
- Willing to participate in the study.
Who cannot join
- 1. Had other neurological and/or psychiatric conditions, such as epilepsy or depression 2. Had a sister or brother with disabilities who attended the centre and received parent-based occupational therapy at the centre where the study was held.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Parent-based Occupational Therapy on Parents of Children With Cerebral Palsy: a Randomised Controlled Trial
Background/Aims Parents of children with cerebral palsy face higher levels of stress, anxiety and depression, sadness, exhaustion and burnout. Parent-based therapies have been found to increase parents' satisfaction with therapy, parent-child interactions and reduced parental stress. This study examined the effects of parent-based occupational therapy on stress levels, coping skills, and emotional skills and competencies of parents of children with cerebral palsy.
Methods A total of 15 children and their parents who were admitted to the paediatric rehabilitation unit for occupational therapy were divided into two groups (control group: n=7, study group: n=8) using the coin toss randomisation method. The control group received standard occupational thearpy, while the study group received parent-based occupational therapy for 45 minutes a session, twice a week, until 10 sessions had been completed. Participants were evaluated before and after the intervention.
Read the detailed description
Cerebral palsy is a disability characterized by movement and posture disorders, loss of motor control, muscle weakness, cognitive deficits, sensory impairment, language and communication problems, and epilepsy, resulting from prenatal, perinatal, and postnatal anomalies. This disability is accompanied by intellectual disability, as well as behavioral and emotional difficulties. Cerebral palsy is one of the main causes of childhood motor disability in developed countries and is reported to affect one out of every 500 births. These effects seen in cerebral palsy have negative consequences regarding social participation. Therefore, interventions for children with cerebral palsy are important and valuable.
Rehabilitation of children with cerebral palsy includes interventions that target the child's problems, skills, opportunities (facilitator), difficulties (obstacle), needs, and relationships with their parents. Occupational therapists plan and apply long-term and follow-up interventions to improve children's independence in their environment, such as self-care, play, school, and leisure time occupations. In studies with children with cerebral palsy, evidence-based interventions, such as constraint-induced movement therapy, hand-arm bimanual intensive training, hand-arm bimanual intensive therapy including lower extremity seem to focus on increasing the functional use of the hemiplegic side.
The Ayres sensory integration intervention approach aims to increase functional skills with necessary sensory experiences and active participation. In addition, the Bobath approach focuses on the child's development at a functional level and being able to participate more in activities by improving muscle tone and postural control. These interventions can be used according to the child's needs. The goal is to improve occupational performance and increase social participation.
The effectiveness of an intervention for children with cerebral palsy is related to the amount and intensity of the treatment, as well as the parent's understanding of their children's skills and ability to interact with their children. Stress, anxiety and depression, sadness, exhaustion, burnout, and disappointment are some of the emotions that negatively affect the interactions of parents with their children, as well as the results of the intervention.
Parent-based intervention approaches include parents in the decision-making and implementation of rehabilitation for their child. Law et al stated that parent-based therapies increased parents' satisfaction with therapy, parent-child interactions and reduced parental stress. Barfoot et al observed that a child with cerebral palsy and his parents achieved both emotional and physical wins through a parent-based intervention.
Novak et al found that parent-based occupational therapy home programs contributed positively to the development of children with cerebral palsy and reduced caregivers' burden. The studies found that the treatment applied to children with cerebral palsy was not sufficient and that parents who spend most of their time at home with their children should be included in the interventions.
It is important to benefit from the parents' expertise and for them to see themselves as a part of the intervention. Therefore the aim of the present study was to examine the effectiveness of the parent-based occupational therapy intervention program on coping skills and stress levels in parents of children with cerebral palsy.
- Conditions
- Cerebral Palsy, Parents
- Being tested
- parent-based occupational therapy, Standard occupational therapy intervention
- Keywords
- cerebral palsy, coping skills, parents, occupational therapy, stress level
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
parent-based occupational therapyOther
Parent-based occupational therapy intervention While the therapist, parent and child were in the therapy area in the first session, the child received the same standard occupational intervention as the control group, and during this process, the parents recorded the therapy with a video recorder. In the second 20 minutes, three activities (such as eating, dressing or mobility activities), which had been decided and planned by the parent and the therapist before the session, were performed by the child and helped by the parent and video-recorded by the occupational therapist.
Standard occupational therapy interventionOther
The sessions in this intervention included the creation of a client-based programme to increase each child's individual skills, functions and social participation. Each session lasted 45 minutes and took place twice a week until 10 sessions had been completed.
Various materials such as toys, blocks, paper and pencils were used to increase the child's participation in daily living, leisure and play activities.
| Study group | Role | What they receive |
|---|---|---|
| study group | Active comparator | Participants (n=15) were randomly selected by the researchers using the coin toss method, and thus the participants were divided into two groups as study (n=8) and control group (n=7) The study group received parent-based occupational therapy, while the control group received standard occupational therapy. Receives: Other: parent-based occupational therapy |
| control group | Active comparator | Participants (n=15) were randomly selected by the researchers using the coin toss method, and thus the participants were divided into two groups as study (n=8) and control group (n=7) The study group received parent-based occupational therapy, while the control group received standard occupational therapy. Receives: Other: Standard occupational therapy intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coping Attitudes Assessment Scale
The Coping Attitudes Assessment Scale, designed to measure the ability to cope with problems that may be encountered in daily life, is a 60-question self-report scale scored between 1 and 4 (1: I never do such a thing, 2: I do this a little, 3: I do this moderately, 4: I do this mostly). It has 15 sub-scales. These sub-scales refer to a distinct coping attitude, such as positive reinterpretation and growth, behavioural disengagement, active coping, planning, restrain and denial. A sub-scale with a high score indicates that the individual uses that coping attitude a lot (Carver et al, 1989). The Turkish version has been found to be valid and reliable (Agargün et al, 2005).
Measured: 6 weeks
Emotional Skills And Competence Questionnaire
The Emotional Skills and Competence Questionnaire is used to evaluate emotional skills and competencies. It is a 45-item measurement tool based on a 5-point Likert-type (1: almost never; 5: almost always). It has three sub-scales: perception and understanding, display and naming, and arrangement. A higher score indicates better emotional skills and competence in this sub-scale (Mayer and Salovey, 1997). The Turkish version has been found to be valid and reliable (Vatan, 2015).
Measured: 6 weeks
Questionnaire on Resources And Stress-F
The Questionnaire on Resources and Stress-F was created to evaluate the stress levels in families with children with disabilities. The scale consists of 52 statements that are answered as true or false. It has three sub-scales: dysfunction, pessimism, and parental and family problems (Holroyd, 1987). The Turkish version has been found to be valid and reliable (Kaner, 2002).
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start1 Feb 2021
- Primary completion1 Aug 2021
- Study completion1 Dec 2022
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Collaborators
- Authors
- Responsible party
- Principal investigator, Gokcen Akyurek, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05728593
- Sponsor's protocol ID
- KA21053
- Status last verified
- Feb 2023
- First submitted
- 26 Jan 2023
- Last updated
- 15 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Parent-based Occupational Therapy on Parents of Children With Cerebral Palsy: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05728593
- Acronym / sponsor ID
- KA21053
- Conditions
- Cerebral Palsy, Parents
- Keywords
- cerebral palsy, coping skills, parents, occupational therapy, stress level
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Collaborators
- Authors
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 15 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.
Background/Aims Parents of children with cerebral palsy face higher levels of stress, anxiety and depression, sadness, exhaustion and burnout. Parent-based therapies have been found to increase parents' satisfaction with therapy, parent-child interactions and reduced parental stress. This study examined the effects of parent-based occupational therapy on stress levels, coping skills, and emotional skills and competencies of parents of children with cerebral palsy.
Methods A total of 15 children and their parents who were admitted to the paediatric rehabilitation unit for occupational therapy were divided into two groups (control group: n=7, study group: n=8) using the coin toss randomisation method. The control group received standard occupational thearpy, while the study group received parent-based occupational therapy for 45 minutes a session, twice a week, until 10 sessions had been completed. Participants were evaluated before and after the intervention.
Detailed description
Cerebral palsy is a disability characterized by movement and posture disorders, loss of motor control, muscle weakness, cognitive deficits, sensory impairment, language and communication problems, and epilepsy, resulting from prenatal, perinatal, and postnatal anomalies. This disability is accompanied by intellectual disability, as well as behavioral and emotional difficulties. Cerebral palsy is one of the main causes of childhood motor disability in developed countries and is reported to affect one out of every 500 births. These effects seen in cerebral palsy have negative consequences regarding social participation. Therefore, interventions for children with cerebral palsy are important and valuable.
Rehabilitation of children with cerebral palsy includes interventions that target the child's problems, skills, opportunities (facilitator), difficulties (obstacle), needs, and relationships with their parents. Occupational therapists plan and apply long-term and follow-up interventions to improve children's independence in their environment, such as self-care, play, school, and leisure time occupations. In studies with children with cerebral palsy, evidence-based interventions, such as constraint-induced movement therapy, hand-arm bimanual intensive training, hand-arm bimanual intensive therapy including lower extremity seem to focus on increasing the functional use of the hemiplegic side.
The Ayres sensory integration intervention approach aims to increase functional skills with necessary sensory experiences and active participation. In addition, the Bobath approach focuses on the child's development at a functional level and being able to participate more in activities by improving muscle tone and postural control. These interventions can be used according to the child's needs. The goal is to improve occupational performance and increase social participation.
The effectiveness of an intervention for children with cerebral palsy is related to the amount and intensity of the treatment, as well as the parent's understanding of their children's skills and ability to interact with their children. Stress, anxiety and depression, sadness, exhaustion, burnout, and disappointment are some of the emotions that negatively affect the interactions of parents with their children, as well as the results of the intervention.
Parent-based intervention approaches include parents in the decision-making and implementation of rehabilitation for their child. Law et al stated that parent-based therapies increased parents' satisfaction with therapy, parent-child interactions and reduced parental stress. Barfoot et al observed that a child with cerebral palsy and his parents achieved both emotional and physical wins through a parent-based intervention.
Novak et al found that parent-based occupational therapy home programs contributed positively to the development of children with cerebral palsy and reduced caregivers' burden. The studies found that the treatment applied to children with cerebral palsy was not sufficient and that parents who spend most of their time at home with their children should be included in the interventions.
It is important to benefit from the parents' expertise and for them to see themselves as a part of the intervention. Therefore the aim of the present study was to examine the effectiveness of the parent-based occupational therapy intervention program on coping skills and stress levels in parents of children with cerebral palsy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Active comparator | Other: parent-based occupational therapyParticipants (n=15) were randomly selected by the researchers using the coin toss method, and thus the participants were divided into two groups as study (n=8) and control group (n=7) The study group received parent-based occupational therapy, while the control group received standard occupational therapy. |
| control group | Active comparator | Other: Standard occupational therapy interventionParticipants (n=15) were randomly selected by the researchers using the coin toss method, and thus the participants were divided into two groups as study (n=8) and control group (n=7) The study group received parent-based occupational therapy, while the control group received standard occupational therapy. |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Children aged between 3 and 12 years who were diagnosed with cerebral palsy and their parents
- Willing to participate in the study
- Able to record videos
- Having the technological equipment to watch the video.
- Children aged between 3 and 12 years who were diagnosed with cerebral palsy and their parents
Key exclusion criteria (1 listed)
- 1. Had other neurological and/or psychiatric conditions, such as epilepsy or depression 2. Had a sister or brother with disabilities who attended the centre and received parent-based occupational therapy at the centre where the study was held.
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 |
|---|---|---|
| parent-based occupational therapyParent-based occupational therapy intervention While the therapist, parent and child were in the therapy area in the first session, the child received the same standard occupational intervention as the control group, and during this process, the parents recorded the therapy with a video recorder. In the second 20 minutes, three activities (such as eating, dressing or mobility activities), which had been decided and planned by the parent and the therapist before the session, were performed by the child and helped by the parent and video-recorded by the occupational therapist. | Other | study group |
| Standard occupational therapy interventionThe sessions in this intervention included the creation of a client-based programme to increase each child's individual skills, functions and social participation. Each session lasted 45 minutes and took place twice a week until 10 sessions had been completed. Various materials such as toys, blocks, paper and pencils were used to increase the child's participation in daily living, leisure and play activities. | Other | control group |
Primary outcome
Coping Attitudes Assessment Scale
Time frame: 6 weeks
The Coping Attitudes Assessment Scale, designed to measure the ability to cope with problems that may be encountered in daily life, is a 60-question self-report scale scored between 1 and 4 (1: I never do such a thing, 2: I do this a little, 3: I do this moderately, 4: I do this mostly). It has 15 sub-scales. These sub-scales refer to a distinct coping attitude, such as positive reinterpretation and growth, behavioural disengagement, active coping, planning, restrain and denial. A sub-scale with a high score indicates that the individual uses that coping attitude a lot (Carver et al, 1989). The Turkish version has been found to be valid and reliable (Agargün et al, 2005).
Emotional Skills And Competence Questionnaire
Time frame: 6 weeks
The Emotional Skills and Competence Questionnaire is used to evaluate emotional skills and competencies. It is a 45-item measurement tool based on a 5-point Likert-type (1: almost never; 5: almost always). It has three sub-scales: perception and understanding, display and naming, and arrangement. A higher score indicates better emotional skills and competence in this sub-scale (Mayer and Salovey, 1997). The Turkish version has been found to be valid and reliable (Vatan, 2015).
Questionnaire on Resources And Stress-F
Time frame: 6 weeks
The Questionnaire on Resources and Stress-F was created to evaluate the stress levels in families with children with disabilities. The scale consists of 52 statements that are answered as true or false. It has three sub-scales: dysfunction, pessimism, and parental and family problems (Holroyd, 1987). The Turkish version has been found to be valid and reliable (Kaner, 2002).
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 15 Feb 2023.
- Individual participant dataSharing planned: No
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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 parent-based occupational therapy and Standard occupational therapy intervention in people with Cerebral Palsy and Parents, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 8 inclusion and 1 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 15 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 Turkey (Türkiye). 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?
Coping Attitudes Assessment Scale (time frame: 6 weeks). 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 15 Feb 2023.