Skip to main content
OpenTrials
Completed

NCT Number: NCT07522086

Occupational Therapy for Caregivers

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Caregiver Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Nervous System Diseases Occupational Balance Occupational Performance Occupational Satisfaction

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sağlık Bilimleri Üniversitesi

Ankara, Keçiören, 06310, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Other names: Occupational Balance Intervention

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.

Other names: Occupational Balance And Life Patterns Awareness Intervention

Primary outcomes

  1. 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

  2. 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.

Other outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Selin Başak Arslaner

Other Gov

Registry information

Official study title

The Effectiveness of Client-Centered Occupational Therapy Intervention for Caregivers of Children With Cerebral Palsy

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 13, 2026
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.