- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07495553
Web-Based Filial Therapy In Pediatric Cancer (Web Based)
A Randomized Controlled Trial Examining the Effect of a Web-Based Filial Therapy Program on Parental Role Perception Among Parents of Children With Cancer
This study examines the effect of a web-based filial therapy program on parental role perception among parents of children diagnosed with cancer. Pediatric cancer not only affects the physical health of the child but also disrupts the emotional and relational dynamics within the family. Due to hospitalization, infection risk, and treatment demands, children may have limited opportunities for play, which is essential for emotional expression and development. At the same time, parents may become primarily focused on the child's medical care and may experience difficulties in maintaining their parenting role.
Filial therapy is an approach that helps parents support their child's emotional needs through structured play. In this study, a 5-week web-based filial therapy program was developed to provide accessible training for parents without requiring separation from their child. Parents learned basic therapeutic play skills and applied them in their daily interactions with their child.
The study was conducted as a randomized controlled trial with 60 parents, divided into intervention and control groups. The results aim to determine whether the program improves parents' perceptions of their parenting role. This research may contribute to the development of accessible psychosocial interventions that support both children and parents in the context of pediatric cancer.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Pediatric cancer affects not only the physical health of the child but also the emotional and relational functioning of the family. Due to hospitalization, infection risk, and intensive treatment protocols, children may experience restricted access to play, school, and peer interaction. These limitations may interfere with the child's ability to express emotions and maintain a sense of normalcy. At the same time, parents often face high levels of stress and may shift from a relational parenting role to a primarily medical caregiving role focused on the child's physical survival.
Filial therapy is a parent-mediated intervention that aims to strengthen the parent-child relationship through structured play interactions. By learning specific therapeutic play skills, parents can support their child's emotional expression and coping processes in a developmentally appropriate way.
In this study, a web-based filial therapy program was developed to provide an accessible and context-sensitive intervention for parents of children diagnosed with cancer. The online format allows parents to receive training without separation from their child and reduces barriers related to infection risk and hospital-based care. The program consisted of five weekly sessions, including video-based instruction, guided practice, and individualized feedback. Parents were trained in core filial therapy skills such as empathic listening, child-led play, emotional reflection, and limit setting, and were encouraged to apply these skills during structured play sessions with their children.
The study was conducted as a randomized controlled trial with parallel group design. A total of 60 parents were randomly assigned to either the intervention group or the control group. The intervention group participated in the web-based filial therapy program, while the control group received no intervention during the study period. Data were collected before and after the intervention using standardized measurement tools to assess parental role perception.
The findings of this study are expected to contribute to the evidence base on parent-mediated interventions and to inform the development of accessible psychosocial support programs for families coping with pediatric cancer.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Samsun
-
Atakent, Samsun, Turkey (Türkiye), 55200
- Ondokuz Mayis Univetsity Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Parent of a child diagnosed with cancer
- Child under 12 years of age
- Living with the child
- Literate
- No diagnosed psychiatric disorder
- Access to a computer and internet connection
- Active use of digital communication tools (internet, phone, or email)
- Willing to participate voluntarily and provide informed consent
Exclusion Criteria:
- Diagnosed psychiatric disorder
- Inability to use digital tools
- Failure to complete the intervention program
- Withdrawal from the study during the intervention period
- Experiencing child loss during the study
- Having a child older than 12 years diagnosed with cancer
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Web-Based Filial Therapy
Participants in this group received a 5-week web-based filial therapy program, including video-based training, structured parent-child play sessions, and individualized feedback.
|
The intervention consisted of a 5-week web-based filial therapy program designed for parents of children diagnosed with cancer. The program included pre-recorded video sessions providing structured training in core filial therapy skills, such as empathic listening, child-led play, emotional reflection, and therapeutic limit setting. Parents were instructed to apply these skills during structured play sessions with their children in their natural environment. To support adherence and intervention fidelity, participants submitted video recordings of their play sessions through the web platform and received individualized feedback from the researcher. The program also included reminder messages and an integrated messaging system to facilitate communication between participants and the researcher. |
|
No Intervention: Control Group
Participants in this group received no intervention during the study period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-Perception of Parental Role Scale (SPPRS)
Time Frame: Pre-test (baseline) and post-test (5 weeks)
|
Self-Perception of Parental Role Scale (SPPRS) total score.
The scale consists of 18 items, with total scores ranging from 18 to 72.
Higher scores indicate a more positive perception of the parental role.
Assessments will be conducted at baseline and after the 5-week intervention period.
|
Pre-test (baseline) and post-test (5 weeks)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: serap GULEC Keskin, Associate Professor, Ondokuz Mayıs University
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
- PYO.SBF.1904.23.012
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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