StressCPNCT06516107
Understanding Parental Stress and Quality of Life in Families of Children With Diplegic Cerebral Palsy: Key Influencing Factors
An observational study of Stress and Diaplegia, run by Sinai University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stress, Diaplegia, Cerebral Palsy
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Jun 2024to 1 Aug 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Parents of Children with diplegic CP age range 2 to 4.5
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
PURPOSE:
To estimate the relationships between the child, parents, and family factors and parent stress and QoL among parents of children with diplegic CP.
Read more
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?
- Conditions
- Stress, Diaplegia, Cerebral Palsy
- Keywords
- Cerebral palsy, Quality of life, Parental stress
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day - one session
Secondary outcomes (2)
Quality of life of parents
Quality of life (QoL) will be measured by the family impact module (PedsQL) and quality-of-life inventory.
Measured: 1 day - one session
Gross motor impairments
Gross motor impairments will be assessed via gross motor classification system
Measured: 1 day - one session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start5 Jun 2024
- Primary completion1 Aug 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Family based
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Sinai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Noureldeen Kora, Sinai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06516107
- Sponsor's protocol ID
- SU.REC.2024(30H)
- Acronym
- CP
- Status last verified
- Feb 2025
- First submitted
- 12 Jul 2024
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
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.
PubMed 33705176Villamor 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.
PubMed 28267854
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Parental Stress and Quality of Life in Families of Children With Diplegic Cerebral Palsy: Key Influencing Factors
- ClinicalTrials.gov ID
- NCT06516107
- Acronym / sponsor ID
- CP / SU.REC.2024(30H)
- Conditions
- Stress, Diaplegia, Cerebral Palsy
- Keywords
- Cerebral palsy, Quality of life, Parental stress
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Sinai UniversityUniversity, hospital or other
- Study start
- 5 Jun 2024 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 23 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Family based
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Parents of Children with diplegic CP age range 2 to 4.5
Key inclusion criteria (2 listed)
- Parents of children between the ages of 2 and 4.8 who had been diagnosed with diplegic CP.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Parental stress
Time frame: 1 day - one session
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.
2 secondary outcomes
Quality of life of parents
Time frame: 1 day - one session
Gross motor impairments
Time frame: 1 day - one session
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- Results publication: PubMed 33705176Dubois-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.
- Results publication: PubMed 28267854Villamor 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.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress and Diaplegia, run by Sinai University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parental stress (time frame: 1 day - one session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06516107, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025.