Child Sexual AbuseNCT05673863
Resilience in Girls Victims of Sexual Abuse
A study testing Psychological Resilience Program in people with Child Sexual Abuse, run by Sakarya University at 1 site in Turkey (Türkiye).
Trial summary
İn this study, it was aimed to examine the effectiveness of the psychological resilience program for adolescent girls after sexual abuse.This study is a randomized controlled trial. Read more about this study
- Who is it for?
- Ages 11 to 16 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Child Sexual Abuse
- What is being tested?
- Psychological Resilience Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2020to 30 Jun 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 11 to 16 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- Having applied to a child advocacy center due to sexual abuse
- Being a girl in the 11-18 age group
- The cognitive competence required to maintain the measurement tools and the training process to have
- Volunteering to participate in the research
- Being open to communication and cooperation
- No severe psychiatric disorder (such as psychosis, neurosis)
- The child can become literate (to be able to use assessment tools)
Who cannot join
- Not wanting to participate in the research
- To continue the group training or to fill in the measurement tools to be applied cognitive and physical dysfunction that would constitute an obstacle.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of the Psychological Resilience Program for the Adolescent Girls Who Are Victims of Sexual Abuse
İn this study, it was aimed to examine the effectiveness of the psychological resilience program for adolescent girls after sexual abuse.This study is a randomized controlled trial.
Read the detailed description
Sexual abuse, which is a universal problem, affects the functioning of many institutions of society and can lead to lifelong physical, mental and social problems and health problems for children.The process of coping and adapting to stressful challenges such as sexual abuse is explained by psychological resilience.
Social support provided by parents, peers and professionals from the onset of sexual abuse contributes positively to children's lives and facilitates adaptation.Group therapies to be applied to abuse victims can increase perceived social support by reducing negative effects such as shame and stigmatization.
- Conditions
- Child Sexual Abuse
- Being tested
- Psychological Resilience Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychological Resilience ProgramBehavioural
The psychological resilience program was applied to the children in the intervention group twice a week for a total of 5 weeks. Each session consisted of 90 minutes of structured practice. The application is carried out using narrative therapy, cognitive behavioral therapy, psychodrama and analogy techniques, self-assessment and didactic teaching techniques. In addition, participants were engaged in self-regulation exercises and positive imagery activities. Each session includes practices on empathy, stress management, resilience, realistic and unrealistic thinking, optimism and pessimism, autonomy and humor related to resilience.
| Study group | Role | What they receive |
|---|---|---|
| Psychological resilience training program | Experimental | Children in the intervention group participated in a psychological resilience program organized as a group activity. Receives: Behavioral: Psychological Resilience Program |
| control group | No intervention | Children in the control group did not receive any intervention. There was also no intervention for the family members accompanying the children. |
What is being measured
The primary outcome is the main question the study is designed to answer.
For children Resiliency Attitudes and Skills Profile (RASP)
The increase in the score obtained from the scale is associated with an increase in resilience. The aim is to define four sub-factors related to psychological resilience: (1) relationships and values, (2) insight and creativity, (3) independence and entrepreneurship, and (4) humor. The scale consists of 34 items on a 4-point Likert scale ranging from strongly disagree (1) to strongly agree (4)
Measured: 6 months
For children Strengths and Difficulties Questionnaire (SDQ) Adolescent Form:
It consists of 24 items and is a 7-point Likert scale ranging from (7) Strongly agree to (1) Strongly disagree. The lowest score obtained from the scale is 24, and the highest score is 168. A high score indicates a high level of self-recovery power.
Measured: 6 months
For children Resilience Scale(RS)
It consists of 24 items and is a 7-point Likert scale ranging from (7) Strongly agree to (1) Strongly disagree. The lowest score obtained from the scale is 24, and the highest score is 168. A high score indicates a high level of self-recovery power.
Measured: 6 months
Secondary outcomes (1)
For parents(Strengths and Difficulties Questionnaire Parent Form (SDQ)
The scale consists of 25 questions and five sub-dimensions, as in the child form. The sub-dimensions, attention deficit and hyperactivity, behavioral problems, emotional problems, and peer problems, show the difficulties experienced separately. The total difficulty score can be calculated by summing these four sub-dimensions. The social behaviors sub-dimension refers to strength.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2023
- Study start1 Jan 2020
- Primary completion15 Jul 2021
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child Sexual AbuseStudies of the same condition, open and under way.
- More trials run by Sakarya 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The sample consisted of girls who agreed to participate in the study and one of their family members (mother, father, aunt, etc.).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GÜLGÜNDURAT, Sakarya University
- Investigators
- GÜLGÜN DURAT, PhD, Principal investigator, Sakarya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05673863
- Sponsor's protocol ID
- SU-OKSAL-001
- Status last verified
- Dec 2022
- First submitted
- 16 Dec 2022
- Last updated
- 6 Jan 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 6 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of the Psychological Resilience Program for the Adolescent Girls Who Are Victims of Sexual Abuse
- ClinicalTrials.gov ID
- NCT05673863
- Acronym / sponsor ID
- SU-OKSAL-001
- Conditions
- Child Sexual Abuse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 15 Jul 2021 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 6 Jan 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.
İn this study, it was aimed to examine the effectiveness of the psychological resilience program for adolescent girls after sexual abuse.This study is a randomized controlled trial.
Detailed description
Sexual abuse, which is a universal problem, affects the functioning of many institutions of society and can lead to lifelong physical, mental and social problems and health problems for children.The process of coping and adapting to stressful challenges such as sexual abuse is explained by psychological resilience.
Social support provided by parents, peers and professionals from the onset of sexual abuse contributes positively to children's lives and facilitates adaptation.Group therapies to be applied to abuse victims can increase perceived social support by reducing negative effects such as shame and stigmatization.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- The sample consisted of girls who agreed to participate in the study and one of their family members (mother, father, aunt, etc.).
| Arm | Type | Receives |
|---|---|---|
| Psychological resilience training program | Experimental | Behavioral: Psychological Resilience ProgramChildren in the intervention group participated in a psychological resilience program organized as a group activity. |
| control group | No intervention | –Children in the control group did not receive any intervention. There was also no intervention for the family members accompanying the children. |
Who may qualify
- Ages
- 11 to 16 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Having applied to a child advocacy center due to sexual abuse
- Being a girl in the 11-18 age group
- The cognitive competence required to maintain the measurement tools and the training process to have
- Volunteering to participate in the research
- Being open to communication and cooperation
Key exclusion criteria (2 listed)
- Not wanting to participate in the research
- To continue the group training or to fill in the measurement tools to be applied cognitive and physical dysfunction that would constitute an obstacle.
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 |
|---|---|---|
| Psychological Resilience ProgramThe psychological resilience program was applied to the children in the intervention group twice a week for a total of 5 weeks. Each session consisted of 90 minutes of structured practice. The application is carried out using narrative therapy, cognitive behavioral therapy, psychodrama and analogy techniques, self-assessment and didactic teaching techniques. In addition, participants were engaged in self-regulation exercises and positive imagery activities. Each session includes practices on empathy, stress management, resilience, realistic and unrealistic thinking, optimism and pessimism, autonomy and humor related to resilience. | Behavioural | Psychological resilience training program |
Primary outcome
For children Resiliency Attitudes and Skills Profile (RASP)
Time frame: 6 months
The increase in the score obtained from the scale is associated with an increase in resilience. The aim is to define four sub-factors related to psychological resilience: (1) relationships and values, (2) insight and creativity, (3) independence and entrepreneurship, and (4) humor. The scale consists of 34 items on a 4-point Likert scale ranging from strongly disagree (1) to strongly agree (4)
For children Strengths and Difficulties Questionnaire (SDQ) Adolescent Form:
Time frame: 6 months
It consists of 24 items and is a 7-point Likert scale ranging from (7) Strongly agree to (1) Strongly disagree. The lowest score obtained from the scale is 24, and the highest score is 168. A high score indicates a high level of self-recovery power.
For children Resilience Scale(RS)
Time frame: 6 months
It consists of 24 items and is a 7-point Likert scale ranging from (7) Strongly agree to (1) Strongly disagree. The lowest score obtained from the scale is 24, and the highest score is 168. A high score indicates a high level of self-recovery power.
1 secondary outcome
For parents(Strengths and Difficulties Questionnaire Parent Form (SDQ)
Time frame: 6 months
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 6 Jan 2023.
- Individual participant dataSharing planned: No
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Partner
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.
GÜLGÜN DURAT, PhD principal investigator
Sakarya University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychological Resilience Program in people with Child Sexual Abuse, run by Sakarya 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 7 inclusion and 2 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 6 Jan 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?
For children Resiliency Attitudes and Skills Profile (RASP) (time frame: 6 months). 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 6 Jan 2023.