Child AbuseNCT05915416
The Effect of Child Abuse and Neglect Prevention Program on Awareness Levels and Child Abuse Potential of Pregnant Women
A study testing Child Abuse and Neglect Prevention Program in people with Child Abuse, run by Koç University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to determine the effect of the Child Abuse and Neglect Prevention Program (CANPP) based on Social Cognitive Theory (SCT) on the awareness levels and child abuse potential of pregnant women. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Child Abuse
- What is being tested?
- Child Abuse and Neglect Prevention Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2022to 1 Dec 2022
- Phase
- Interventional
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pregnant women who agree to participate in the study
- are 18 years of age or older
- who can read and understand Turkish
- who have either a smart phone or a computer
- are between 28+0 and 33+0 weeks of pregnancy
Who cannot join
- Pregnant women with high risk pregnancy
- who have visual or auditory problems
- who have been diagnosed with mental disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Child Abuse and Neglect Prevention Program on Awareness Levels and Child Abuse Potential of Pregnant Women: A Randomized Controlled Study
The aim of this study is to determine the effect of the Child Abuse and Neglect Prevention Program (CANPP) based on Social Cognitive Theory (SCT) on the awareness levels and child abuse potential of pregnant women. This randomized controlled study was conducted between July and December 2022 in a family health center of Aydin/Turkey with the participation a total of 30 pregnant women, who were then distributed into two groups as 15 experiment group and 15 control group pregnant women.The participants in the experiment group were applied SCT-based CANPP whereas no intervention was applied to the control group. Research data were collected before the intervention, one month after the intervention, and three months after the intervention using the Pregnant Data Collection Form, Child Neglect and Abuse Awareness Scale for Parents (CNAASP) and Child Abuse Potential Inventory (CAPI). Chi-Square and Fisher exact tests, independent groups t-test and repeated measures ANOVA test were used in the statistical analysis of the research data.
- Conditions
- Child Abuse
- Being tested
- Child Abuse and Neglect Prevention Program
- Keywords
- child abuse, awareness, pregnant, nurse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Child Abuse and Neglect Prevention ProgramBehavioural
The Child Abuse and Neglect Prevention Program was then revised in line with the opinions and suggestions of the experts. Power-point presentations and training booklet prepared for the final form of this program have been prepared in such a way that the content is exactly the same. Training booklet was distributed to the experiment group after the pre-test and to the control group after the re-test. This booklet is designed as a resource that participants can refer to whenever they need it. Trainings were provided online through the Google Meet application, in a total of four sessions with an average of 30 minutes per session. The contents of the trainings are child neglect, physical abuse, emotional abuse and sexual abuse, respectively. Four different power-point presentations, addressing these sub-dimensions, were prepared for training purposes.
| Study group | Role | What they receive |
|---|---|---|
| Experiment Group | Experimental | The participants in the experiment group were first administered the pre-test and then CANPP. A Child abuse and neglect Training Booklet was sent to the participants after the pre-test and before the program. Trainings within the scope of CANPP were provided over the Google Meet application in four sessions. A link was sent to the pregnant women via WhatsApp just before the specified training hours so that they could participate in the online training which is carried out individually. Receives: Behavioral: Child Abuse and Neglect Prevention Program |
| Control group | No intervention | Participants in control group does not receive intervention. They were then applied CANPP and were given the training booklet after the finalization the program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child Neglect and Abuse Awareness Scale for Parents
Child Neglect and Abuse Awareness Scale for Parents is a 5-point Likert-type scale (1-strongly disagree, 2-disagree, 3-undecided, 4-agree, 5-strongly agree) and consisting of 45 items in total. The scale has 5 sub-dimensions namely General Information (12 items), Physical Abuse (6 items), Emotional Abuse (15 items), Sexual Abuse (8 items), Neglect (4 items). By adding all sub-dimensions, the Child Neglect and Abuse Awareness Scale for Parents total score is calculated. The higher this total score, the higher the awareness of child abuse and neglect.
Measured: one month after the intervention
Child Neglect and Abuse Awareness Scale for Parents
Child Neglect and Abuse Awareness Scale for Parents is a 5-point Likert-type scale (1-strongly disagree, 2-disagree, 3-undecided, 4-agree, 5-strongly agree) and consisting of 45 items in total. The scale has 5 sub-dimensions namely General Information (12 items), Physical Abuse (6 items), Emotional Abuse (15 items), Sexual Abuse (8 items), Neglect (4 items). By adding all sub-dimensions, the Child Neglect and Abuse Awareness Scale for Parents total score is calculated. The higher this total score, the higher the awareness of child abuse and neglect.
Measured: three months after the intervention
Secondary outcomes (2)
Child Abuse Potential Inventory
Child Abuse Potential Inventory used in this study was first developed in 1979 to determine the child abuse potential of adults towards children. Main scale of Child Abuse Potential Inventory is the "abuse scale" (77 items) which measures the child abuse potential of the respondent. Remaining 6 scales (Stress scale, Unhappiness scale, Problems Related to Child and Self scale, Family-Related Problems and Problems Related to Others Scale measure factors related to abuse. Three scales, namely Lie Scale, Random Response Scale and Inconsistency Scale were designed to assess the validity of responses. This study is based on the Child Abuse Potential Inventory 'Abuse Scale'. The cut-off point for abuse scale is 215, but above 166 is considered dangerous. High scores in abuse scale indicate that the respondent has a high potential for child abuse.
Measured: one month after the intervention
Child Abuse Potential Inventory
Child Abuse Potential Inventory used in this study was first developed in 1979 to determine the child abuse potential of adults towards children. Main scale of Child Abuse Potential Inventory is the "abuse scale" (77 items) which measures the child abuse potential of the respondent. Remaining 6 scales (Stress scale, Unhappiness scale, Problems Related to Child and Self scale, Family-Related Problems and Problems Related to Others Scale measure factors related to abuse. Three scales, namely Lie Scale, Random Response Scale and Inconsistency Scale were designed to assess the validity of responses. This study is based on the Child Abuse Potential Inventory 'Abuse Scale'. The cut-off point for abuse scale is 215, but above 166 is considered dangerous. High scores in abuse scale indicate that the respondent has a high potential for child abuse.
Measured: three month after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2023
- Study start1 Jul 2022
- Primary completion1 Aug 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child AbuseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Koç University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Damla Özçevik Subaşı, Koç University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05915416
- Sponsor's protocol ID
- KocU-OZCEVIKSUBASI-001
- Status last verified
- Jun 2023
- First submitted
- 13 Jun 2023
- Last updated
- 23 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Child Abuse and Neglect Prevention Program on Awareness Levels and Child Abuse Potential of Pregnant Women: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05915416
- Acronym / sponsor ID
- KocU-OZCEVIKSUBASI-001
- Conditions
- Child Abuse
- Keywords
- child abuse, awareness, pregnant, nurse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Koç UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 23 Jun 2023 (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.
The aim of this study is to determine the effect of the Child Abuse and Neglect Prevention Program (CANPP) based on Social Cognitive Theory (SCT) on the awareness levels and child abuse potential of pregnant women. This randomized controlled study was conducted between July and December 2022 in a family health center of Aydin/Turkey with the participation a total of 30 pregnant women, who were then distributed into two groups as 15 experiment group and 15 control group pregnant women.The participants in the experiment group were applied SCT-based CANPP whereas no intervention was applied to the control group. Research data were collected before the intervention, one month after the intervention, and three months after the intervention using the Pregnant Data Collection Form, Child Neglect and Abuse Awareness Scale for Parents (CNAASP) and Child Abuse Potential Inventory (CAPI). Chi-Square and Fisher exact tests, independent groups t-test and repeated measures ANOVA test were used in the statistical analysis of the research data.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experiment Group | Experimental | Behavioral: Child Abuse and Neglect Prevention ProgramThe participants in the experiment group were first administered the pre-test and then CANPP. A Child abuse and neglect Training Booklet was sent to the participants after the pre-test and before the program. Trainings within the scope of CANPP were provided over the Google Meet application in four sessions. A link was sent to the pregnant women via WhatsApp just before the specified training hours so that they could participate in the online training which is carried out individually. |
| Control group | No intervention | –Participants in control group does not receive intervention. They were then applied CANPP and were given the training booklet after the finalization the program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Pregnant women who agree to participate in the study
- are 18 years of age or older
- who can read and understand Turkish
- who have either a smart phone or a computer
- are between 28+0 and 33+0 weeks of pregnancy
Key exclusion criteria (3 listed)
- Pregnant women with high risk pregnancy
- who have visual or auditory problems
- who have been diagnosed with mental disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Child Abuse and Neglect Prevention ProgramThe Child Abuse and Neglect Prevention Program was then revised in line with the opinions and suggestions of the experts. Power-point presentations and training booklet prepared for the final form of this program have been prepared in such a way that the content is exactly the same. Training booklet was distributed to the experiment group after the pre-test and to the control group after the re-test. This booklet is designed as a resource that participants can refer to whenever they need it. Trainings were provided online through the Google Meet application, in a total of four sessions with an average of 30 minutes per session. The contents of the trainings are child neglect, physical abuse, emotional abuse and sexual abuse, respectively. Four different power-point presentations, addressing these sub-dimensions, were prepared for training purposes. | Behavioural | Experiment Group |
Primary outcome
Child Neglect and Abuse Awareness Scale for Parents
Time frame: one month after the intervention
Child Neglect and Abuse Awareness Scale for Parents is a 5-point Likert-type scale (1-strongly disagree, 2-disagree, 3-undecided, 4-agree, 5-strongly agree) and consisting of 45 items in total. The scale has 5 sub-dimensions namely General Information (12 items), Physical Abuse (6 items), Emotional Abuse (15 items), Sexual Abuse (8 items), Neglect (4 items). By adding all sub-dimensions, the Child Neglect and Abuse Awareness Scale for Parents total score is calculated. The higher this total score, the higher the awareness of child abuse and neglect.
Child Neglect and Abuse Awareness Scale for Parents
Time frame: three months after the intervention
Child Neglect and Abuse Awareness Scale for Parents is a 5-point Likert-type scale (1-strongly disagree, 2-disagree, 3-undecided, 4-agree, 5-strongly agree) and consisting of 45 items in total. The scale has 5 sub-dimensions namely General Information (12 items), Physical Abuse (6 items), Emotional Abuse (15 items), Sexual Abuse (8 items), Neglect (4 items). By adding all sub-dimensions, the Child Neglect and Abuse Awareness Scale for Parents total score is calculated. The higher this total score, the higher the awareness of child abuse and neglect.
2 secondary outcomes
Child Abuse Potential Inventory
Time frame: one month after the intervention
Child Abuse Potential Inventory
Time frame: three month after the intervention
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 23 Jun 2023.
- Individual participant dataSharing planned: No
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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?
A study testing Child Abuse and Neglect Prevention Program in people with Child Abuse, run by Koç 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 5 inclusion and 3 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 23 Jun 2023. 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?
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?
Child Neglect and Abuse Awareness Scale for Parents (time frame: one month after the intervention). The study lists 2 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 23 Jun 2023.