Understanding Parental Stress and Quality of Life in Families of Children With Diplegic Cerebral Palsy: Key Influencing Factors (CP)

PURPOSE:

To estimate the relationships between the child, parents, and family factors and parent stress and QoL among parents of children with diplegic CP.

BACKGROUND:

Cerebral palsy (CP) is considered the primary reason of motor impairment among children worldwide. Compared to parents of typically developing children, parents of children with cerebral palsy (CP) experience higher levels of stress and reduced quality of life (QoL).

HYPOTHESES:

There is no relation between the level of functional impairment among children with diplegic CP and their parental stress and QOL.

RESEARCH QUESTION:

Is there a relationship between the level of functional impairment among children with diplegic CP and the degree of their parental stress and quality of life?

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy; Stress; Diaplegia

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Egypt
  • Ismailia, Egypt
    • Sinai university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Parents of Children with diplegic CP age range 2 to 4.5

Description

Inclusion Criteria:

• Parents of children between the ages of 2 and 4.8 who had been diagnosed with diplegic CP.

  • Parents of children with diplegic CP who were in a stable clinical and medical state.

Exclusion Criteria:

• parents of children with behavioral problem.
• a history of ongoing heart disease
• a botulinum toxin injection within the six months previous to the study
• chronic chest disease
• significant visual or auditory impairment
• parents with limited literacy

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

1 Group of parents of children with diplegic cerebral palsy; Parents of children between the ages of 2 and 4.8 who had been diagnosed with diplegic CP and were in a stable clinical and medical state will be included in this study. However, parents of children with behavioral problems, a history of ongoing heart disease, a botulinum toxin injection within the six months previous to the study, chronic chest disease, significant visual or auditory impairment, or parents with limited literacy will not allowed to participate in the study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parental stress	Parental stress will be measured by the Arabic version of the parent stress index-short form (PSI-SF) . PSI-SF is a self-reported questionnaire with 36 items rated on a 5-point Likert scale (strongly agree or strongly disagree). The score of the measure ranged between 36 and 180, and a lower score indicates a better outcome.	1 day - one session

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life of parents	Quality of life (QoL) will be measured by the family impact module (PedsQL) and quality-of-life inventory.	1 day - one session
Gross motor impairments	Gross motor impairments will be assessed via gross motor classification system	1 day - one session

Collaborators and Investigators

• Sponsor: Sinai University

Publications and helpful links

General Publications

• Dubois-Comtois K, St-Onge J, St-Laurent D, Cyr C. Paternal distress and child behavior problems in low-SES families: Quality of father-child interactions as mediators. J Fam Psychol. 2021 Sep;35(6):725-734. doi: 10.1037/fam0000830. Epub 2021 Mar 11.
• Villamor E, Tedroff K, Peterson M, Johansson S, Neovius M, Petersson G, Cnattingius S. Association Between Maternal Body Mass Index in Early Pregnancy and Incidence of Cerebral Palsy. JAMA. 2017 Mar 7;317(9):925-936. doi: 10.1001/jama.2017.0945.

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2024
• Primary Completion (Actual): August 1, 2024
• Study Completion (Actual): August 1, 2024

Study Registration Dates

• First Submitted: July 12, 2024
• First Submitted That Met QC Criteria: July 17, 2024
• First Posted (Actual): July 23, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 17, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Quality of life; Cerebral palsy; Parental stress
• Additional Relevant MeSH Terms: Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy; Paralysis
• Other Study ID Numbers: SU.REC.2024(30H)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

IPD Plan Description

Privacy Concerns: IPD can be very detailed and contain sensitive information about participants, such as their medical history, diagnoses, and treatment responses. Sharing this data could potentially identify participants, even if it is de-identified. This can be a major concern, especially for studies involving rare diseases or conditions.

Data Security: Making IPD publicly available raises risks of data breaches or unauthorized access. Researchers need to be confident they have robust security measures in place to protect sensitive participant information.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No