FamilyNCT05066295
Validation and Reliability of the Parents Assessment of Protective Factors Survey
An observational study of Family, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
Neglect and abuse, which have a devastating effect on children, can be prevented with community-based education programs aimed at strengthening families. The study aimed to validate and determine reliability of the "Parents Assessment of Protective Factors (PAPF) survey" and to develop a culturally appropriate program… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Family
- How many people
- 500 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Oct 2021to Oct 2023
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Parents of children aged between 0 to 8 years
Who may be able to join
- Parents of children aged between 0 to 8 years
- Ability to read and complete the self-assessment questionnaires
Who cannot join
- Parents who do not give consent to participate in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University School of Medicine
Istanbul
About this study
Official title: Strengthening Families to Prevent Child Neglect and Abuse With Community Based Protective Approaches: Culturally Appropriate Program Development and Educational Design
Neglect and abuse, which have a devastating effect on children, can be prevented with community-based education programs aimed at strengthening families. The study aimed to validate and determine reliability of the "Parents Assessment of Protective Factors (PAPF) survey" and to develop a culturally appropriate program and educational design for strengthening families.
Read the detailed description
The American Center for Social Policy Studies (CSSP) Center for Quality Improvement in Early Childhood (QIC_EC) defined protective factors that will form the basis of programs designed to prevent neglect and abuse, with community-based approaches. Community-based programs for primary prevention should be developed to prevent neglect and abuse, before it occurs. Existing studies in our country show that there is rarely a focus on preventing adverse childhood experiences with primary preventive approaches. Most of the studies are school-based, and aimed at increasing awareness of children and families about abuse.
This study aimed to evaluate the Turkish translation of the PAPF survey for validity and reliability and to adapt a culturally appropriate program and educational design for strengthening families, with a multidisciplinary team.
In the first step of the study, Turkish validity and reliability of the Parents Assessment of Protective Factors (PAPF) survey, will be conducted and applied to parents to determinate the protective factors. Turkish version of Adverse Childhood Experience Questionnaire (ACE), will be applied simultaneously with the PAPF survey, to identify adverse childhood experiences of parents that might affect parental resilience, parenting characteristics, and family dynamics.
In the second phase of the study, community-based family education programs that are currently being implemented in different countries will be reviewed by a multidisciplinary team (healthcare professionals, social workers and non-governmental organizations). A culturally appropriate educational primary prevention program for child neglect and abuse will be developed.
- Conditions
- Family
- Keywords
- parents' assessment, protective factors, child abuse, prevention, validity
What is being measured
The primary outcome is the main question the study is designed to answer.
Turkish Validation of The Parents Assessment of Protective Factors (PAPF) Survey
Parents Assessment of Protective Factors (PAPF) Survey will be validated
Measured: Baseline
Turkish Reliability of The Parents Assessment of Protective Factors (PAPF) Survey
Parents Assessment of Protective Factors (PAPF) Survey will be tested for reliability
Measured: Baseline
Turkish Reliability of The Parents Assessment of Protective Factors (PAPF) Survey
Parents Assessment of Protective Factors (PAPF) Survey will be tested for reliability
Measured: at 6 months
Secondary outcomes (3)
Subscale scores for each protective factors
Parents Assessment of Protective Factors (PAPF) Survey subscale scores will be computed. Higher scores indicate greater protective factors.
Measured: Baseline
Protective Factors Index (PFI)
Parents Assessment of Protective Factors (PAPF) Survey total scores will be summed
Measured: Baseline
Adverse Childhood Events
Adverse Childhood Events will be measured with Adverse Childhood Events Questionnaire.
Higher scores indicate increased exposure to trauma, which have been associated with a greater risk of negative consequences.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2021
- Study startOct 2021 (estimated)
- Primary completionOct 2022 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FamilyStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Perran Boran, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05066295
- Sponsor's protocol ID
- 09.2021.848
- Status last verified
- Sep 2021
- First submitted
- 23 Sep 2021
- Last updated
- 4 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Requests for wider sharing of data (for example in response to publications about the study and willingness to share), will be addressed on a case-by-case basis. Any data sharing request will be made to investigators through a pre-defined data requisition form. This form will contain information about the applicant, institution, purpose of data request, study objectives, ethical clearance of the study, etc. Once a request has been made the data governance body will discuss if that request was appropriate; data will be released following signing of the data sharing agreement. The data will be stored on the Marmara University servers and not be deposited in any 'community' database.
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strengthening Families to Prevent Child Neglect and Abuse With Community Based Protective Approaches: Culturally Appropriate Program Development and Educational Design
- ClinicalTrials.gov ID
- NCT05066295
- Acronym / sponsor ID
- 09.2021.848
- Conditions
- Family
- Keywords
- parents' assessment, protective factors, child abuse, prevention, validity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- Oct 2021 (estimated)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 4 Oct 2021 (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.
Neglect and abuse, which have a devastating effect on children, can be prevented with community-based education programs aimed at strengthening families. The study aimed to validate and determine reliability of the "Parents Assessment of Protective Factors (PAPF) survey" and to develop a culturally appropriate program and educational design for strengthening families.
Detailed description
The American Center for Social Policy Studies (CSSP) Center for Quality Improvement in Early Childhood (QIC_EC) defined protective factors that will form the basis of programs designed to prevent neglect and abuse, with community-based approaches. Community-based programs for primary prevention should be developed to prevent neglect and abuse, before it occurs. Existing studies in our country show that there is rarely a focus on preventing adverse childhood experiences with primary preventive approaches. Most of the studies are school-based, and aimed at increasing awareness of children and families about abuse.
This study aimed to evaluate the Turkish translation of the PAPF survey for validity and reliability and to adapt a culturally appropriate program and educational design for strengthening families, with a multidisciplinary team.
In the first step of the study, Turkish validity and reliability of the Parents Assessment of Protective Factors (PAPF) survey, will be conducted and applied to parents to determinate the protective factors. Turkish version of Adverse Childhood Experience Questionnaire (ACE), will be applied simultaneously with the PAPF survey, to identify adverse childhood experiences of parents that might affect parental resilience, parenting characteristics, and family dynamics.
In the second phase of the study, community-based family education programs that are currently being implemented in different countries will be reviewed by a multidisciplinary team (healthcare professionals, social workers and non-governmental organizations). A culturally appropriate educational primary prevention program for child neglect and abuse will be developed.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Parents of children aged between 0 to 8 years
Key inclusion criteria (2 listed)
- Parents of children aged between 0 to 8 years
- Ability to read and complete the self-assessment questionnaires
Key exclusion criteria (1 listed)
- Parents who do not give consent to participate in the study
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
Turkish Validation of The Parents Assessment of Protective Factors (PAPF) Survey
Time frame: Baseline
Parents Assessment of Protective Factors (PAPF) Survey will be validated
Turkish Reliability of The Parents Assessment of Protective Factors (PAPF) Survey
Time frame: Baseline
Parents Assessment of Protective Factors (PAPF) Survey will be tested for reliability
Turkish Reliability of The Parents Assessment of Protective Factors (PAPF) Survey
Time frame: at 6 months
Parents Assessment of Protective Factors (PAPF) Survey will be tested for reliability
3 secondary outcomes
Subscale scores for each protective factors
Time frame: Baseline
Protective Factors Index (PFI)
Time frame: Baseline
Adverse Childhood Events
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2021.
- Individual participant dataSharing planned: No. Requests for wider sharing of data (for example in response to publications about the study and willingness to share), will be addressed on a case-by-case basis. Any data sharing request will be made to investigators through a pre-defined data requisition form. This form will contain information about the applicant, institution, purpose of data request, study objectives, ethical clearance of the study, etc. Once a request has been made the data governance body will discuss if that request was appropriate; data will be released following signing of the data sharing agreement. The data will be stored on the Marmara University servers and not be deposited in any 'community' database.
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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 Family, run by Marmara University at 1 site in Turkey (Türkiye).
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 1 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: status not confirmed, as of the sponsor's last update on 4 Oct 2021. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
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?
Turkish Validation of The Parents Assessment of Protective Factors (PAPF) Survey (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Oct 2021.