- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06159075
Reducing Self-Stigma Among Individuals with History of Childhood Maltreatment: a Cross-Cultural Lens
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 investigators hypothesize that:
- The brief video-based intervention will have the immediate and repeated effect of reducing self-stigma among CM survivors compared with the control condition.
- The brief video-based intervention will increase seeking treatment compared with the control condition.
- The brief video-based intervention will show similar effects in reducing self-stigma across multiple countries.
Study Overview
Status
Intervention / 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.
Four hundred participants with self-reported 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 an 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 actor, but without a personal narrative of CM experience. 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.
The results will be analyzed alongside results from parallel protocols being conducted by partner sites in other countries (Switzerland, Sweden, Japan, Peru, India, Australia, Turkey, South Africa, and Israel). Each site will conduct the study under their own university's purview and with their own protocol, and only deidentified data will be shared for analysis.
All study procedures will be conducted remotely via CloudReseach and Mechanical Turk, which is a crowdsourcing platform. The study survey will be hosted by Qualtrics.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10032
- New York State Psychiatric Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- N/A
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Video with Childhood Maltreatment-Related Content
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.
|
A short video aimed at reducing self-stigma among individuals with a history of childhood maltreatment and increasing their help seeking intentions (if needed).
|
|
No Intervention: Control Video
Participants in this arm will view a same-length video with the same actor, but without a personal narrative of CM experience.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
Immediately post-intervention
|
|
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)
|
30 days post-intervention
|
|
Help Seeking Intentions - 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)
|
Immediately post-intervention
|
|
Help Seeking Intentions - 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)
|
30 days post-intervention
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Yuval Neria, PhD, NYSPI and Columbia University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 8453a
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
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