The Effect of Child Abuse and Neglect Prevention Program on Awareness Levels and Child Abuse Potential of Pregnant Women

June 21, 2023 updated by: Damla Özçevik Subaşı, Koç University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34100
        • Koç University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Pregnant women with high risk pregnancy
  • who have visual or auditory problems
  • who have been diagnosed with mental disorders.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experiment Group
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.
Behavioral: Child Abuse and Neglect Prevention Program
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.
No Intervention: Control group
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
one month after the intervention
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.
three months after the intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Child Abuse Potential Inventory
Time Frame: one month after the intervention
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.
one month after the intervention
Child Abuse Potential Inventory
Time Frame: three month after the intervention
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.
three month after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Koç University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 13, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 21, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 23, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 23, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 21, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KocU-OZCEVIKSUBASI-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings