Stigma, SocialNCT05818228
Reducing Self-Stigma Among Individuals with History of Childhood Maltreatment
A study testing Video in people with Stigma, Social and Child Abuse, run by Research Foundation for Mental Hygiene, Inc. at 1 site in United States.
Trial summary
Individuals who report experiencing any kind of abuse during childhood report shame and self-blame, often leading to self-stigma and a reluctance to reveal their experiences and seek help. Such stigma may aggravate the mental health consequences of child maltreatment (CM). Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Stigma, Social, Child Abuse, Child Neglect
- What is being tested?
- Video
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 685 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Apr 2023to 30 Sep 2023
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-80
- US resident
- Individuals who endorse yes to one of the following items: physical aggression in family or household, emotional or verbal abuse in family or household, sexual abuse or inappropriate sexual experiences, negligence - physical or emotional, mental illness or substance abuse at home, incarceration of family member
- Fluent in English and able to give informed consent
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
United States1 site
New York State Psychiatric Institute
New York, New York, 10032
About this study
Official title: Reducing Self-Stigma Among Individuals with History of Childhood Maltreatment: a Randomized Controlled Trial
Individuals who report experiencing any kind of abuse during childhood report shame and self-blame, often leading to self-stigma and a reluctance to reveal their experiences and seek help. Such stigma may aggravate the mental health consequences of child maltreatment (CM).
The aim of the proposed study is twofold: (1) to evaluate the effectiveness of a brief video-based intervention in reducing self-stigma among individuals who experienced childhood abuse and/or maltreatment, and (2) to increase openness to seeking treatment.
Read the detailed description
Prior research suggests that social contact-based interventions are the most efficient way of reducing stigma. This study aims to address self-stigma and empower individuals who self-reported experiencing any kind of abuse during childhood and increase their openness to seeking help, if needed.
A total of 1000 adults with self-report experience of any kind of childhood abuse will be recruited to participate in a Randomized Controlled Trial (RCT) testing the efficacy of the intervention. Participants will be randomized into one of two arms: 1) A 2-minute video intervention in which a CM survivor (presented by either a female or male actor) shares their personal CM experience and describes how they were able to overcome feelings of shame and self-blame to seek mental health care; or 2) A 2-minute control video using the same actors, but without CM-related content. Both videos will be preceded by and immediately followed by questionnaires assessing self-stigma and openness to seeking treatment. An additional assessment of emotional engagement will be added immediately following intervention delivery. Following the intervention, there will be a 30-day follow-up to examine potential long-term effects.
- Conditions
- Stigma, Social, Child Abuse, Child Neglect, Help-Seeking Behavior
- Being tested
- Video
- Medical subject headings
- Social Stigma, Help-Seeking Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VideoBehavioural
A short video aimed at reducing self-stigma among individuals with a history of childhood maltreatment and increasing their help seeking intentions (if needed).
| Study group | Role | What they receive |
|---|---|---|
| Video with Childhood Maltreatment-Related Content | Experimental | Participants will view a video of an actor describing the story of an individual who experienced childhood maltreatment and how they overcame its effects on their life. Receives: Behavioral: Video |
| Video without Childhood Maltreatment Content | No intervention | Participants will view a lifestyle video of an actor describing their day-to-day experiences, without any childhood maltreatment-related themes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Stigma Questionnaire - Post-Intervention
Change in stigma items from baseline - higher score indicates higher stigma (range of 15 to 60)
Measured: Immediately post-intervention
Self-Stigma Questionnaire - Follow-Up
Change in stigma items from baseline - higher score indicates higher stigma (range of 15 to 60)
Measured: 30 days post-intervention
Help Seeking Intentions (3 items of the ATSPPH) - Post-Intervention
Change in treatment-seeking intentions from baseline - higher score indicates higher help-seeking intentions (range of 3 to 12)
Measured: Immediately post-intervention
Help Seeking Intentions (3 items of the ATSPPH) - Follow-Up
Change in treatment-seeking intentions from baseline - higher score indicates higher help-seeking intentions (range of 3 to 12)
Measured: 30 days post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start26 Apr 2023
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stigma, SocialStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 685 participants (actual)
Sponsor and investigators
- Lead sponsor
- Research Foundation for Mental Hygiene, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Columbia University
- Responsible party
- Principal investigator, Yuval Y Neria, Research Foundation for Mental Hygiene, Inc.
- Investigators
- Yuval Neria, PhD, Principal investigator, NYSPI and Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05818228
- Sponsor's protocol ID
- 8453
- Status last verified
- Feb 2025
- First submitted
- 5 Apr 2023
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Haim-Nachum S, Lazarov A, Zabag R, Martin A, Bergman M, Neria Y, Amsalem D. Self-stigma mediates the relationships between childhood maltreatment and symptom levels of PTSD, depression, and anxiety. Eur J Psychotraumatol. 2024;15(1):2370174. doi: 10.1080/20008066.2024.2370174. Epub 2024 Jul 10.
PubMed 38985020
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Self-Stigma Among Individuals with History of Childhood Maltreatment: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05818228
- Acronym / sponsor ID
- 8453
- Conditions
- Stigma, Social, Child Abuse, Child Neglect, Help-Seeking Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 685 participants (actual)
- Lead sponsor
- Research Foundation for Mental Hygiene, Inc.University, hospital or other
- Collaborators
- Columbia University
- Study start
- 26 Apr 2023 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 18 Apr 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.
Individuals who report experiencing any kind of abuse during childhood report shame and self-blame, often leading to self-stigma and a reluctance to reveal their experiences and seek help. Such stigma may aggravate the mental health consequences of child maltreatment (CM).
The aim of the proposed study is twofold: (1) to evaluate the effectiveness of a brief video-based intervention in reducing self-stigma among individuals who experienced childhood abuse and/or maltreatment, and (2) to increase openness to seeking treatment.
Detailed description
Prior research suggests that social contact-based interventions are the most efficient way of reducing stigma. This study aims to address self-stigma and empower individuals who self-reported experiencing any kind of abuse during childhood and increase their openness to seeking help, if needed.
A total of 1000 adults with self-report experience of any kind of childhood abuse will be recruited to participate in a Randomized Controlled Trial (RCT) testing the efficacy of the intervention. Participants will be randomized into one of two arms: 1) A 2-minute video intervention in which a CM survivor (presented by either a female or male actor) shares their personal CM experience and describes how they were able to overcome feelings of shame and self-blame to seek mental health care; or 2) A 2-minute control video using the same actors, but without CM-related content. Both videos will be preceded by and immediately followed by questionnaires assessing self-stigma and openness to seeking treatment. An additional assessment of emotional engagement will be added immediately following intervention delivery. Following the intervention, there will be a 30-day follow-up to examine potential long-term effects.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Video with Childhood Maltreatment-Related Content | Experimental | Behavioral: VideoParticipants will view a video of an actor describing the story of an individual who experienced childhood maltreatment and how they overcame its effects on their life. |
| Video without Childhood Maltreatment Content | No intervention | –Participants will view a lifestyle video of an actor describing their day-to-day experiences, without any childhood maltreatment-related themes. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-80
- US resident
- Individuals who endorse yes to one of the following items: physical aggression in family or household, emotional or verbal abuse in family or household, sexual abuse or inappropriate sexual experiences, negligence - physical or emotional, mental illness or substance abuse at home, incarceration of family member
- Fluent in English and able to give informed consent
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| VideoA short video aimed at reducing self-stigma among individuals with a history of childhood maltreatment and increasing their help seeking intentions (if needed). | Behavioural | Video with Childhood Maltreatment-Related Content |
Primary outcome
Self-Stigma Questionnaire - Post-Intervention
Time frame: Immediately post-intervention
Change in stigma items from baseline - higher score indicates higher stigma (range of 15 to 60)
Self-Stigma Questionnaire - Follow-Up
Time frame: 30 days post-intervention
Change in stigma items from baseline - higher score indicates higher stigma (range of 15 to 60)
Help Seeking Intentions (3 items of the ATSPPH) - Post-Intervention
Time frame: Immediately post-intervention
Change in treatment-seeking intentions from baseline - higher score indicates higher help-seeking intentions (range of 3 to 12)
Help Seeking Intentions (3 items of the ATSPPH) - Follow-Up
Time frame: 30 days post-intervention
Change in treatment-seeking intentions from baseline - higher score indicates higher help-seeking intentions (range of 3 to 12)
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 13 Feb 2025.
- Derived from this study: PubMed 38985020Haim-Nachum S, Lazarov A, Zabag R, Martin A, Bergman M, Neria Y, Amsalem D. Self-stigma mediates the relationships between childhood maltreatment and symptom levels of PTSD, depression, and anxiety. Eur J Psychotraumatol. 2024;15(1):2370174. doi: 10.1080/20008066.2024.2370174. Epub 2024 Jul 10.
- 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.
Yuval Neria, PhD principal investigator
NYSPI and Columbia 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 Video in people with Stigma, Social and Child Abuse, run by Research Foundation for Mental Hygiene, Inc. at 1 site in United States.
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 4 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: finished, as of the sponsor's last update on 13 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 United States. 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?
Self-Stigma Questionnaire - Post-Intervention (time frame: Immediately post-intervention). The study lists 4 primary outcomes in all. 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 NCT05818228, which also lists 1 linked publication.
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 13 Feb 2025.