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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
What is being tested?
Client-Centered Occupational Therapy Intervention
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

Other trials in Turkey (Türkiye)

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 groups in NCT07522086
Study groupRoleWhat they receive
Interventiton GroupActive comparatorParticipants 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 GroupPlacebo comparatorThe 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.

  1. 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)

  2. 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.

  1. First posted13 Apr 2026
  2. Study start8 Oct 2024
  3. Primary completion26 Mar 2025
  4. Study completion26 May 2025

Resources

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)
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

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.

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