CaregiverNCT07522086
Occupational Therapy for Caregivers
A study testing Client-Centered Occupational Therapy Intervention in people with Caregiver and Occupational Balance, run by Selin Başak Arslaner at 1 site in Turkey (Türkiye).
Trial summary
This study examines a client-centered occupational therapy program developed for caregivers of children with cerebral palsy. Caregivers often have difficulty managing their daily activities because of caregiving responsibilities, which can affect how they organize their daily routines. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Caregiver, Occupational Balance, Occupational Performance
- What is being tested?
- Client-Centered Occupational Therapy Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Oct 2024to 26 May 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Being the primary caregiver of a child with diplegic CP.
- Having access to a device with internet connectivity.
- Being capable of following verbal and written instructions.
- Volunteering to participate in the study.
- Scoring 5 or below in the Performance and Satisfaction dimensions of the Canadian Occupational Performance Measure (COPM) or scoring 16 or below on the Occupational Balance Questionnaire.
- Scoring 21 or above on the Caregiver Burden Scale.
Show all 11Show fewer
- Being between the ages of 4 and 18 years.
- Being classified as Level IV or above according to the Gross Motor Function Classification System (GMFCS).
- Being classified as Level III or above according to the Manual Ability Classification System (MACS).
- Being classified as Level II or above according to the Communication Function Classification System (CFCS).
- Being classified as Level III or above according to the Eating and Drinking Ability Classification System (EDACS).
Who cannot join
- Had previously received professional services or interventions specifically designed for caregivers,
- Had a neurological, psychiatric, or chronic condition, such as multiple sclerosis, schizophrenia, or diabetes
- Using medications (e.g., sedatives, antidepressants, or potent analgesics)
- Having an additional neurological diagnosis alongside CP (e.g., hydrocephalus, epilepsy).
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sağlık Bilimleri Üniversitesi
Ankara, Keçiören, 06310
About this study
Official title: The Effectiveness of Client-Centered Occupational Therapy Intervention for Caregivers of Children With Cerebral Palsy
This study examines a client-centered occupational therapy program developed for caregivers of children with cerebral palsy. Caregivers often have difficulty managing their daily activities because of caregiving responsibilities, which can affect how they organize their daily routines.
In this study, caregivers take part in an 8-week program that focuses on improving daily life balance through goal setting, awareness of time use, and activity planning. The program is designed to help caregivers better organize their daily routines and balance different types of activities.
Read more
Participants are randomly assigned to either an intervention group or a control group. Outcomes such as daily activity balance, activity performance, and caregiving-related difficulties are measured before and after the program.
The aim of this study is to examine whether a client-centered occupational therapy program can improve daily life balance and activity performance and reduce caregiving-related difficulties in caregivers of children with cerebral palsy.
- Being tested
- Client-Centered Occupational Therapy Intervention, Control Group Intervention
- Keywords
- caregiver, occupational therapy, occupational balance, occupational satisfaction, occupational performance, cerebral palsy
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Client-Centered Occupational Therapy InterventionBehavioural
Also called Occupational Balance Intervention
The intervention was structured around Wagman and Håkansson's three dimensions of occupational balance: occupational areas, occupations of different characteristics, and time use.
Occupational Areas: Focused on self-care, productivity, and leisure. Participants utilized "tiny habits" and habit-stacking strategies to integrate these areas into their daily routines.
Occupations of Different Characteristics: Addressed the nature of activities. It combined energy conservation for physical tasks, stress management for mental occupations, and social engagement. A personalized "Occupational Menu" was created to balance active and passive recreation.
Time Use: Concentrated on identifying "time consumers" and applying a five-step time management strategy. Participants developed individualized timelines based on their COPM results.
Delivered over eight weeks, the program used weekly feedback on time-use patterns to ensure a client-centered approach to achieving occupational harmony.
Control Group InterventionBehavioural
Also called Occupational Balance And Life Patterns Awareness Intervention
The control group received a single-session intervention focused on occupational balance and life pattern awareness, with a mean duration of 45 minutes. The session consisted of a brief psychoeducational presentation covering the concept of occupational balance, the distribution of ADLs, and the role of balanced routines in well-being. Participants were encouraged to reflect on their own daily routines; however, no individualized intervention strategies, goal setting, or structured follow-up were implemented.
| Study group | Role | What they receive |
|---|---|---|
| Interventiton Group | Active comparator | Participants in this arm received a structured, client-centered occupational therapy intervention focused on occupational balance. The program consisted of 8 weekly individual sessions (45 minutes each), delivered either face-to-face or online. The intervention was based on Wagman and Håkansson's three dimensions: occupational areas, occupations of different characteristics, and time use. Techniques such as habit stacking, energy conservation, and time management strategies were implemented. Receives: Behavioral: Client-Centered Occupational Therapy Intervention |
| Control Group | Placebo comparator | The control group received a single session of occupational balance and life pattern awareness sessions. Receives: Behavioral: Control Group Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occupational Balance Questionnaire
Wagman and Ha˚kansson (2014) developed the Occupational Balance Questionnaire (OBQ), a scale that measures self-rated occupational balance. The questionnaire had good internal consistency (Cronbach's alpha¼0.936) and adequate test-retest reliability (Spearman's rho¼0.926 for total score) in healthy adults. The OBQ was designed to analyze both at-item level and as a summed total score (Wagman, \& Ha˚kansson, 2014). Ha˚kansson et al. (2020) reported that the OBQ11 had good reliability (0.92), model fit, and measurement invariance across age and gender groups. Günal et al. (2020) performed the Turkish adaptation and validity and reliability studies to obtain the OBQ11-T. Test-retest reliability of the OBQ11-T was 0.922, and Cronbach's alpha for OBQ11-T total score was 0.785. The scale consists of 11 items scored on a 4-point scale from 'strongly disagree' (scored 0) to 'strongly agree' (scored 3). The total score is obtained by summing the individual items and ranges from 0 to 33. Higher
Measured: Baseline and after 8 weeks (post-intervention)
Canadian Occupational Performance Measure (COPM)
It is a semi-structured scale that helps to identify problematic areas of performance experienced by individuals and to measure their perceived occupational performance and occupational satisfaction. This scale assesses the level of performance of self-care, productivity and leisure occupations and satisfaction with these performances as perceived by the individual. The importance of each occupation is measured on a 10-point scale (1 = not at all important, 10 = very important) according to the individual's perception. In the next step, the individual is asked to select five occupations that he/she considers most important and to rate separately his/her performance (1 = could not do it, 10 = could do it very well) and satisfaction (1 = not satisfied, 10 = very satisfied) in these occupations (Torpil et al., 2021). Cronbach's alpha for COPM Turkish total score was 0.95.
Measured: Baseline and after 8 weeks (post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start8 Oct 2024
- Primary completion26 Mar 2025
- Study completion26 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CaregiverStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selin Başak Arslaner
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Selin Başak Arslaner, Lokman Hekim University
- Investigators
- Serkan P Pekçetin, Professor, Principal investigator, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07522086
- Sponsor's protocol ID
- SArslaner
- Status last verified
- Apr 2026
- First submitted
- 3 Mar 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Participant Data (IPD) will not be shared to protect the privacy and confidentiality of the participants. The informed consent obtained from caregivers and children did not include provisions for the public sharing of raw data. Furthermore, the study has been completed and the data analysis for the primary research objectives has been finalized.
Publications
Gunal A, Pekcetin S, Wagman P, Hakansson C, Kayihan H. Occupational balance and quality of life in mothers of children with cerebral palsy. Br J Occup Ther. 2022 Jan;85(1):37-43. doi: 10.1177/0308022621995112. Epub 2021 May 5.
PubMed 40337105
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Client-Centered Occupational Therapy Intervention for Caregivers of Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT07522086
- Acronym / sponsor ID
- SArslaner
- Keywords
- caregiver, occupational therapy, occupational balance, occupational satisfaction, occupational performance, cerebral palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Selin Başak ArslanerOther government
- Study start
- 8 Oct 2024 (actual)
- Primary completion
- 26 Mar 2025 (actual)
- Study completion
- 26 May 2025 (actual)
- First posted
- 13 Apr 2026 (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.
This study examines a client-centered occupational therapy program developed for caregivers of children with cerebral palsy. Caregivers often have difficulty managing their daily activities because of caregiving responsibilities, which can affect how they organize their daily routines.
In this study, caregivers take part in an 8-week program that focuses on improving daily life balance through goal setting, awareness of time use, and activity planning. The program is designed to help caregivers better organize their daily routines and balance different types of activities.
Participants are randomly assigned to either an intervention group or a control group. Outcomes such as daily activity balance, activity performance, and caregiving-related difficulties are measured before and after the program.
The aim of this study is to examine whether a client-centered occupational therapy program can improve daily life balance and activity performance and reduce caregiving-related difficulties in caregivers of children with cerebral palsy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventiton Group | Active comparator | Behavioral: Client-Centered Occupational Therapy InterventionParticipants in this arm received a structured, client-centered occupational therapy intervention focused on occupational balance. The program consisted of 8 weekly individual sessions (45 minutes each), delivered either face-to-face or online. The intervention was based on Wagman and Håkansson's three dimensions: occupational areas, occupations of different characteristics, and time use. Techniques such as habit stacking, energy conservation, and time management strategies were implemented. |
| Control Group | Placebo comparator | Behavioral: Control Group InterventionThe control group received a single session of occupational balance and life pattern awareness sessions. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Being the primary caregiver of a child with diplegic CP.
- Having access to a device with internet connectivity.
- Being capable of following verbal and written instructions.
- Volunteering to participate in the study.
- Scoring 5 or below in the Performance and Satisfaction dimensions of the Canadian Occupational Performance Measure (COPM) or scoring 16 or below on the Occupational Balance Questionnaire.
Key exclusion criteria (4 listed)
- Had previously received professional services or interventions specifically designed for caregivers,
- Had a neurological, psychiatric, or chronic condition, such as multiple sclerosis, schizophrenia, or diabetes
- Using medications (e.g., sedatives, antidepressants, or potent analgesics)
- Having an additional neurological diagnosis alongside CP (e.g., hydrocephalus, epilepsy).
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 |
|---|---|---|
| Client-Centered Occupational Therapy InterventionAlso: Occupational Balance InterventionThe intervention was structured around Wagman and Håkansson's three dimensions of occupational balance: occupational areas, occupations of different characteristics, and time use. Occupational Areas: Focused on self-care, productivity, and leisure. Participants utilized "tiny habits" and habit-stacking strategies to integrate these areas into their daily routines. Occupations of Different Characteristics: Addressed the nature of activities. It combined energy conservation for physical tasks, stress management for mental occupations, and social engagement. A personalized "Occupational Menu" was created to balance active and passive recreation. Time Use: Concentrated on identifying "time consumers" and applying a five-step time management strategy. Participants developed individualized timelines based on their COPM results. Delivered over eight weeks, the program used weekly feedback on time-use patterns to ensure a client-centered approach to achieving occupational harmony. | Behavioural | Interventiton Group |
| Control Group InterventionAlso: Occupational Balance And Life Patterns Awareness InterventionThe control group received a single-session intervention focused on occupational balance and life pattern awareness, with a mean duration of 45 minutes. The session consisted of a brief psychoeducational presentation covering the concept of occupational balance, the distribution of ADLs, and the role of balanced routines in well-being. Participants were encouraged to reflect on their own daily routines; however, no individualized intervention strategies, goal setting, or structured follow-up were implemented. | Behavioural | Control Group |
Primary outcome
Occupational Balance Questionnaire
Time frame: Baseline and after 8 weeks (post-intervention)
Wagman and Ha˚kansson (2014) developed the Occupational Balance Questionnaire (OBQ), a scale that measures self-rated occupational balance. The questionnaire had good internal consistency (Cronbach's alpha¼0.936) and adequate test-retest reliability (Spearman's rho¼0.926 for total score) in healthy adults. The OBQ was designed to analyze both at-item level and as a summed total score (Wagman, \& Ha˚kansson, 2014). Ha˚kansson et al. (2020) reported that the OBQ11 had good reliability (0.92), model fit, and measurement invariance across age and gender groups. Günal et al. (2020) performed the Turkish adaptation and validity and reliability studies to obtain the OBQ11-T. Test-retest reliability of the OBQ11-T was 0.922, and Cronbach's alpha for OBQ11-T total score was 0.785. The scale consists of 11 items scored on a 4-point scale from 'strongly disagree' (scored 0) to 'strongly agree' (scored 3). The total score is obtained by summing the individual items and ranges from 0 to 33. Higher
Canadian Occupational Performance Measure (COPM)
Time frame: Baseline and after 8 weeks (post-intervention)
It is a semi-structured scale that helps to identify problematic areas of performance experienced by individuals and to measure their perceived occupational performance and occupational satisfaction. This scale assesses the level of performance of self-care, productivity and leisure occupations and satisfaction with these performances as perceived by the individual. The importance of each occupation is measured on a 10-point scale (1 = not at all important, 10 = very important) according to the individual's perception. In the next step, the individual is asked to select five occupations that he/she considers most important and to rate separately his/her performance (1 = could not do it, 10 = could do it very well) and satisfaction (1 = not satisfied, 10 = very satisfied) in these occupations (Torpil et al., 2021). Cronbach's alpha for COPM Turkish total score was 0.95.
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 13 Apr 2026.
- Background: PubMed 40337105Gunal A, Pekcetin S, Wagman P, Hakansson C, Kayihan H. Occupational balance and quality of life in mothers of children with cerebral palsy. Br J Occup Ther. 2022 Jan;85(1):37-43. doi: 10.1177/0308022621995112. Epub 2021 May 5.
- Individual participant dataSharing planned: No. Individual Participant Data (IPD) will not be shared to protect the privacy and confidentiality of the participants. The informed consent obtained from caregivers and children did not include provisions for the public sharing of raw data. Furthermore, the study has been completed and the data analysis for the primary research objectives has been finalized.
Related trials for Caregiver
Recruiting
Developing a Scalable Tobacco Cessation Program for Cancer Survivors and Caregivers
Nicotine Use, Tobacco Use
Active, not recruiting
Emergency Preparedness for Caregivers of Persons With Dementia: Disaster PrepWise
Caregiver Resilience and Stress
Not yet recruitingObservational study
Factors Influencing Adoption of a Novel Malaria Treatment in Côte d'Ivoire, Ghana, and Rwanda
Malaria
Not yet recruitingObservational study
Phase 1: Thrive Together
Attention-Deficit/Hyperactivity Disorder (ADHD)
Recruiting
The WeACT Program for Family Caregivers of People Living With Dementia
Depression, Caregivers
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.
Serkan P Pekçetin, Professor principal investigator
Saglik Bilimleri Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Client-Centered Occupational Therapy Intervention in people with Caregiver and Occupational Balance, run by Selin Başak Arslaner 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 11 inclusion and 4 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 13 Apr 2026. 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. Some participants in this study may receive a placebo. 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?
Occupational Balance Questionnaire (time frame: Baseline and after 8 weeks (post-intervention)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07522086, which also lists 1 linked publication.
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 13 Apr 2026.