NCT05728593

Brief Summary

Background/Aims Parents of children with cerebral palsy face higher levels of stress, anxiety and depression, sadness, exhaustion and burnout. Parent-based therapies have been found to increase parents' satisfaction with therapy, parent-child interactions and reduced parental stress. This study examined the effects of parent-based occupational therapy on stress levels, coping skills, and emotional skills and competencies of parents of children with cerebral palsy. Methods A total of 15 children and their parents who were admitted to the paediatric rehabilitation unit for occupational therapy were divided into two groups (control group: n=7, study group: n=8) using the coin toss randomisation method. The control group received standard occupational thearpy, while the study group received parent-based occupational therapy for 45 minutes a session, twice a week, until 10 sessions had been completed. Participants were evaluated before and after the intervention.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 26, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 15, 2023

Completed
Last Updated

February 15, 2023

Status Verified

February 1, 2023

Enrollment Period

6 months

First QC Date

January 26, 2023

Last Update Submit

February 5, 2023

Conditions

Keywords

cerebral palsycoping skillsparentsoccupational therapystress level

Outcome Measures

Primary Outcomes (3)

  • Coping Attitudes Assessment Scale

    The Coping Attitudes Assessment Scale, designed to measure the ability to cope with problems that may be encountered in daily life, is a 60-question self-report scale scored between 1 and 4 (1: I never do such a thing, 2: I do this a little, 3: I do this moderately, 4: I do this mostly). It has 15 sub-scales. These sub-scales refer to a distinct coping attitude, such as positive reinterpretation and growth, behavioural disengagement, active coping, planning, restrain and denial. A sub-scale with a high score indicates that the individual uses that coping attitude a lot (Carver et al, 1989). The Turkish version has been found to be valid and reliable (Agargün et al, 2005).

    6 weeks

  • Emotional Skills And Competence Questionnaire

    The Emotional Skills and Competence Questionnaire is used to evaluate emotional skills and competencies. It is a 45-item measurement tool based on a 5-point Likert-type (1: almost never; 5: almost always). It has three sub-scales: perception and understanding, display and naming, and arrangement. A higher score indicates better emotional skills and competence in this sub-scale (Mayer and Salovey, 1997). The Turkish version has been found to be valid and reliable (Vatan, 2015).

    6 weeks

  • Questionnaire on Resources And Stress-F

    The Questionnaire on Resources and Stress-F was created to evaluate the stress levels in families with children with disabilities. The scale consists of 52 statements that are answered as true or false. It has three sub-scales: dysfunction, pessimism, and parental and family problems (Holroyd, 1987). The Turkish version has been found to be valid and reliable (Kaner, 2002).

    6 weeks

Study Arms (2)

study group

ACTIVE COMPARATOR

Participants (n=15) were randomly selected by the researchers using the coin toss method, and thus the participants were divided into two groups as study (n=8) and control group (n=7) The study group received parent-based occupational therapy, while the control group received standard occupational therapy.

Other: parent-based occupational therapy

control group

ACTIVE COMPARATOR

Participants (n=15) were randomly selected by the researchers using the coin toss method, and thus the participants were divided into two groups as study (n=8) and control group (n=7) The study group received parent-based occupational therapy, while the control group received standard occupational therapy.

Other: Standard occupational therapy intervention

Interventions

Parent-based occupational therapy intervention While the therapist, parent and child were in the therapy area in the first session, the child received the same standard occupational intervention as the control group, and during this process, the parents recorded the therapy with a video recorder. In the second 20 minutes, three activities (such as eating, dressing or mobility activities), which had been decided and planned by the parent and the therapist before the session, were performed by the child and helped by the parent and video-recorded by the occupational therapist.

study group

The sessions in this intervention included the creation of a client-based programme to increase each child's individual skills, functions and social participation. Each session lasted 45 minutes and took place twice a week until 10 sessions had been completed. Various materials such as toys, blocks, paper and pencils were used to increase the child's participation in daily living, leisure and play activities.

control group

Eligibility Criteria

Age3 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children aged between 3 and 12 years who were diagnosed with cerebral palsy and their parents
  • Willing to participate in the study
  • Able to record videos
  • Having the technological equipment to watch the video.
  • Children aged between 3 and 12 years who were diagnosed with cerebral palsy and their parents
  • Willing to participate in the study.

You may not qualify if:

  • \. Had other neurological and/or psychiatric conditions, such as epilepsy or depression 2. Had a sister or brother with disabilities who attended the centre and received parent-based occupational therapy at the centre where the study was held.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Researchers were not blinded to group assignments and interventions. However, the participants were blinded about the purpose of the study and the groups they were in.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

January 26, 2023

First Posted

February 15, 2023

Study Start

February 1, 2021

Primary Completion

August 1, 2021

Study Completion

December 1, 2022

Last Updated

February 15, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations