Occupational Therapy for Caregivers

NCT07522086 | Completed

• 1 other identifier: SArslaner
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Caregiver; Occupational Balance; Occupational Performance; Occupational Satisfaction

Keywords

caregiver; occupational therapy; occupational balance; occupational satisfaction; occupational performance; cerebral palsy

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  Baseline and after 8 weeks (post-intervention)

Other Outcomes (1)

• Burden Interview (BI)

  Baseline and after 8 weeks (post-intervention)

Study Arms (2)

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.

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.

Behavioral: Control Group Intervention

Interventions

Client-Centered Occupational Therapy Intervention BEHAVIORAL

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.

Also known as: Occupational Balance Intervention

Interventiton Group

Control Group Intervention BEHAVIORAL

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.

Also known as: Occupational Balance And Life Patterns Awareness Intervention

Control Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)
• 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).
• \- Having an additional neurological diagnosis alongside CP (e.g., hydrocephalus, epilepsy).

Sponsors & Collaborators

• Selin Başak Arslaner: lead

Study Sites (1)

Sağlık Bilimleri Üniversitesi

Ankara, Keçiören, 06310, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 40337105 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Serkan P Pekçetin, Professor

  Saglik Bilimleri Universitesi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: March 3, 2026
• First Posted: April 13, 2026
• Study Start: October 8, 2024
• Primary Completion: March 26, 2025
• Study Completion: May 26, 2025
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)