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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06159075
Other study ID # 8453a
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date January 2024
Est. completion date March 2024

Study information

Verified date December 2023
Source Research Foundation for Mental Hygiene, Inc.
Contact Yuval Neria, PhD
Phone 914-498-0412
Email yuval.neria@nyspi.columbia.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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). The investigators hypothesize that: 1. The brief video-based intervention will have the immediate and repeated effect of reducing self-stigma among CM survivors compared with the control condition. 2. The brief video-based intervention will increase seeking treatment compared with the control condition. 3. The brief video-based intervention will show similar effects in reducing self-stigma across multiple countries.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 400
Est. completion date March 2024
Est. primary completion date March 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design


Intervention

Behavioral:
Video
A short video aimed at reducing self-stigma among individuals with a history of childhood maltreatment and increasing their help seeking intentions (if needed).

Locations

Country Name City State
United States New York State Psychiatric Institute New York New York

Sponsors (2)

Lead Sponsor Collaborator
Research Foundation for Mental Hygiene, Inc. Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Self-Stigma Questionnaire - Post-Intervention Change in stigma items from baseline - higher score indicates higher stigma (range of 15 to 60) Immediately post-intervention
Primary Self-Stigma Questionnaire - Follow-Up Change in stigma items from baseline - higher score indicates higher stigma (range of 15 to 60) 30 days post-intervention
Primary Help Seeking Intentions - Post-Intervention Change in treatment-seeking intentions from baseline - higher score indicates higher help-seeking intentions (range of 3 to 12) Immediately post-intervention
Primary Help Seeking Intentions - Follow-Up Change in treatment-seeking intentions from baseline - higher score indicates higher help-seeking intentions (range of 3 to 12) 30 days post-intervention
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