- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07594730
RCT of Brief Intervention Addressing Stigma Among Parents of Children With Mental Health Problems
The goal of this study is to test the efficacy of brief video interventions parental internalized stigma and stigma-related outcomes (e.g., treatment intentions, caregiver burden, secrecy) among parents (ages 25-50) of children ages 6-18 with depression, ADHD, or substance use problems.
Timely identification and treatment of mental health problems in youth is a public health priority. However, many youth do not receive treatment, and stigma has been identified as the primary barrier to help-seeking. Parents experience stigma related to their children having mental health problems, which has been associated with reduced help-seeking and increased parental distress. Prior experiments have found brief video-based interventions (BVIs), 1-2 minute videos similar to those viewed by youth on social media platforms, based on the principle of "social contact" with individuals affected by a stigmatized condition, effective in reducing mental health stigma and increasing help-seeking.
In this 4-arm RCT, we will recruit parents aged 25-50 using an online crowdsourcing platform, to test the efficacy of BVIs featuring a personal parent narrative of their experience with their child's a) depression, b) ADHD, or c) substance use, or d) a control condition that provides general written psychoeducational information without social contact.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Brief video-based interventions (BVIs) have been studied as a means of reducing stigma toward mental health problems and increasing help-seeking. "Contact-based interventions," in which a representative of a stigmatized group shares their personal stories, have been found one of the most effective anti-stigma interventions. Effective contact-based interventions target to a specific population, account for the specific interests of that population, and credibly provide stories that highlight recovery in a plausible manner to moderately disconfirm stereotypes. BVIs package contact-based stigma interventions into short (1-2 minute) messages in the style of social media content. Prior RCTs have tested BVIs targeting depression-related stigma in adolescents, featuring a young person describing experiences with depressive symptoms, that improved as they sought support from parents and professionals. Parents often experience stigma to their children's mental health problems and play a critical gate-keeping role for children accessing mental health treatment. Additionally, parental stigma is associated with child mental health outcomes, and potential mediators between parental stigma and child outcomes including parental wellbeing, attitudes toward the child, help-seeking, and self-efficacy. Thus, we hypothesize that BVIs targeted to parents of children with similar mental health conditions (e.g., depression, ADHD, or substance use) will have greater impact on reducing stigma and increasing treatment intentions than generic written psychoeducational content without a social contact component.
We will measure distinct stigma-related outcomes relevant to parents of children with mental health problems:
- Parental internalized stigma
- Treatment intentions
- Treatment engagement
- Attitudes toward the child
- Caregiver burden
- Self-efficacy
- secrecy coping (i.e., to avoid potential negative repercussions of stigma).
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Doron Amsalem, MD
- Phone Number: 929-404-8802
- Email: doron.amsalem@nyspi.columbia.edu
Study Contact Backup
- Name: Timothy Becker, MD
- Phone Number: 914-997-5203
- Email: tdb2143@cumc.columbia.edu
Study Locations
-
-
New York
-
New York, New York, United States, 10032
- Columbia University Irving Medical Center
-
Contact:
- Doron Amsalem, MD
- Phone Number: 929-404-8802
- Email: doron.amsalem@nyspi.columbia.edu
-
Contact:
- Timothy Becker, MD
- Phone Number: 914-997-5203
- Email: tdb2143@cumc.columbia.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Self-identify as English Speaking
- Live in the US
- Ages 25-50
- Have a child 6-18 years old with either depression, ADHD, or a substance use problem
Exclusion Criteria:
- Do not speak English
- Do not live in the US
- <25 or >50
- Do not have a child between ages 6-18 with depression, ADHD, or a substance use problem
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: Experimental: Depression social contact brief video
Novel brief video (1-2 mins) in which a mother talks about their child's depression, impact of the parent, how parent helped support recovery
|
Brief video about depression (arm 1), ADHD (arm 2), or substance use (arm 3)
|
|
Experimental: Experimental: ADHD social contact brief video
Novel brief video (1-2 mins) in which a mother talks about their child's ADHD, impact on the parent, how parent helped support recovery
|
Brief video about depression (arm 1), ADHD (arm 2), or substance use (arm 3)
|
|
Experimental: Experimental: substance use social contact brief video
Novel brief video (1-2 mins) in which a mother talks about their child's depression, impact on the parent, how parent helped support recovery
|
Brief video about depression (arm 1), ADHD (arm 2), or substance use (arm 3)
|
|
No Intervention: Control
Written psychoeducational information about children's mental health, treatment options, and how parents can support child
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Parental Internalized Stigma of Mental Illness scale (PISMI)
Time Frame: Immediately after viewing video, 30 days after intervention
|
Measures internalized stigma among parents of children with mental health problems
|
Immediately after viewing video, 30 days after intervention
|
|
Attitudes Toward Seeking Professional Psychological Help Scale-Short Form (adapted)
Time Frame: Immediately after viewing video, 30 days after intervention
|
3-item measure of treatment intentions, modified for parents of children with mental health problems
|
Immediately after viewing video, 30 days after intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Zarit Burden Interview screen
Time Frame: Immediately after viewing video, 30 days after intervention
|
Brief measure of caregiver burden
|
Immediately after viewing video, 30 days after intervention
|
|
Secrecy coping scale (adapted)
Time Frame: Immediately after viewing video, 30 days after intervention
|
Parental attitudes toward concealing the child's problems from others
|
Immediately after viewing video, 30 days after intervention
|
|
Parental self-efficacy
Time Frame: Immediately after viewing video, 30 days after intervention
|
Single item measure from Parenting sense of competence (PSOC) scale
|
Immediately after viewing video, 30 days after intervention
|
|
Parental attitudes and responses toward adolescent depression (adapted)
Time Frame: Immediately after viewing video, 30 days after intervention
|
Select items measuring critical and supportive responses to child's emotional needs
|
Immediately after viewing video, 30 days after intervention
|
|
Treatment engagement
Time Frame: 30 days after intervention
|
3 questions about considering treatment, taking steps to start treatment, or starting treatment in the prior 30 days
|
30 days after intervention
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Doron Amsalem, MD, Columbia University; New York State Psychiatric Institute
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Additional Relevant MeSH Terms
- Mental Disorders
- Behavioral Symptoms
- Chemically-Induced Disorders
- Neurodevelopmental Disorders
- Stress, Psychological
- Attention Deficit and Disruptive Behavior Disorders
- Behavior
- Social Behavior
- Caregiver Burden
- Substance-Related Disorders
- Attention Deficit Disorder with Hyperactivity
- Social Stigma
- Help-Seeking Behavior
Other Study ID Numbers
- AAAV7555
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
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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