- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07594730
Brief Intervention Addressing Stigma Among Parents of Children With Mental Health Problems
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, the investigators 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.
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
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, the investigators 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.
This study 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).
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Doron Amsalem, MD
- Telefonnummer: 929-404-8802
- E-mail: doron.amsalem@nyspi.columbia.edu
Undersøgelse Kontakt Backup
- Navn: Timothy Becker, MD
- Telefonnummer: 914-997-5203
- E-mail: tdb2143@cumc.columbia.edu
Studiesteder
-
-
New York
-
New York, New York, Forenede Stater, 10032
- Columbia University Irving Medical Center
-
Kontakt:
- Doron Amsalem, MD
- Telefonnummer: 929-404-8802
- E-mail: doron.amsalem@nyspi.columbia.edu
-
Kontakt:
- Timothy Becker, MD
- Telefonnummer: 914-997-5203
- E-mail: tdb2143@cumc.columbia.edu
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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)
|
|
Eksperimentel: 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)
|
|
Eksperimentel: 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)
|
|
Ingen indgriben: Control
Written psychoeducational information about children's mental health, treatment options, and how parents can support child
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Parental Internalized Stigma of Mental Illness scale (PISMI)
Tidsramme: Immediately after viewing video, 30 days after intervention
|
Measures internalized stigma among parents of children with mental health problems; scores range 12-48; higher scores indicate worse outcomes
|
Immediately after viewing video, 30 days after intervention
|
|
Attitudes Toward Seeking Professional Psychological Help Scale-Short Form (adapted)
Tidsramme: Immediately after viewing video, 30 days after intervention
|
3-item measure of treatment intentions, modified for parents of children with mental health problems; scores range 0-9; higher scores indicate better outcomes
|
Immediately after viewing video, 30 days after intervention
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Zarit Burden Interview screen
Tidsramme: Immediately after viewing video, 30 days after intervention
|
Brief measure of caregiver burden; scores range 0-16; higher scores indicate worse outcomes
|
Immediately after viewing video, 30 days after intervention
|
|
Secrecy coping scale (adapted)
Tidsramme: Immediately after viewing video, 30 days after intervention
|
Parental attitudes toward concealing the child's problems from others; scores range 4-24; higher scores indicate worse outcomes
|
Immediately after viewing video, 30 days after intervention
|
|
Parental self-efficacy
Tidsramme: Immediately after viewing video, 30 days after intervention
|
Single item measure from Parenting sense of competence (PSOC) scale; scores range 1-6; higher scores indicate better outcomes
|
Immediately after viewing video, 30 days after intervention
|
|
Parental attitudes and responses toward adolescent depression (adapted)
Tidsramme: Immediately after viewing video, 30 days after intervention
|
Select items measuring critical and supportive responses to child's emotional needs; scores range 0-32; higher scores indicate better outcomes
|
Immediately after viewing video, 30 days after intervention
|
|
Treatment engagement
Tidsramme: 30 days after intervention
|
3 questions about considering treatment, taking steps to start treatment, or starting treatment in the prior 30 days; yes/no categorical responses - no minimum or maximum values
|
30 days after intervention
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Doron Amsalem, MD, Columbia University; New York State Psychiatric Institute
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Psykiske lidelser
- Adfærdsmæssige symptomer
- Kemisk inducerede lidelser
- Neuroudviklingsforstyrrelser
- Stress, psykologisk
- Opmærksomhedsunderskud og forstyrrende adfærdsforstyrrelser
- Opførsel
- Social adfærd
- Plejerbyrde
- Stof-relaterede lidelser
- Attention Deficit Disorder med hyperaktivitet
- Socialt stigma
- Hjælpesøgende adfærd
Andre undersøgelses-id-numre
- AAAV7555
Plan for individuelle deltagerdata (IPD)
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