- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07522086
Occupational Therapy for Caregivers
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.
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 Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Keçiören
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Ankara, Keçiören, Turkey (Türkiye), 06310
- Sağlık Bilimleri Üniversitesi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria for Caregivers:
- 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.
Exclusion Criteria for Caregivers:
- 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)
Inclusion Criteria for Children:
- 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).
Exclusion Criteria for Children:
- Having an additional neurological diagnosis alongside CP (e.g., hydrocephalus, epilepsy).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Interventiton Group
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.
|
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.
Other Names:
|
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Placebo Comparator: Control Group
The control group received a single session of occupational balance and life pattern awareness sessions.
|
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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Baseline and after 8 weeks (post-intervention)
|
|
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.
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Baseline and after 8 weeks (post-intervention)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Burden Interview (BI)
Time Frame: Baseline and after 8 weeks (post-intervention)
|
The scale was developed by Zarit, Reever, and Bach-Peterson in 1980 to assess the difficulties experienced by caregivers (93).
It consists of 22 items, each scored on a scale from 0 to 4, yielding a total score ranging from 0 to 88. Scores between 0-22 indicate little or no caregiving burden, 21-40 indicate a moderate burden, 41-60 indicate a severe burden, and 61-88 indicate an excessive caregiving burden.
The Turkish validity and reliability study of the scale was conducted by İnci et al., and the Cronbach's alpha reliability coefficient was reported as 0.95
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Baseline and after 8 weeks (post-intervention)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Serkan P Pekçetin, Professor, Saglik Bilimleri Universitesi
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SArslaner
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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