NCT03597048

Brief Summary

This is a school-based field experiment conducted in sixth grade classrooms to evaluate a multifaceted intervention designed to change attitudes and behaviors regarding mental illnesses. The research tests hypotheses as to whether alone or in combination interventions that are 1) a curriculum-based in-class presentations, 2) contact-based with a person who has experienced a mental illness, or 3) or based on educational materials distributed in classes improve knowledge/attitudes and encourage help seeking for mental health problems in a follow up study lasting two years.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
751

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2011

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2015

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

June 27, 2018

Completed
27 days until next milestone

First Posted

Study publicly available on registry

July 24, 2018

Completed
Last Updated

July 24, 2018

Status Verified

July 1, 2018

Enrollment Period

4 years

First QC Date

June 27, 2018

Last Update Submit

July 13, 2018

Conditions

Keywords

stigma intervention

Outcome Measures

Primary Outcomes (2)

  • Changes in Knowledge and Attitudes about Mental Illness

    This is a 21-item measure (alpha .78) adapted from items created by Wahl and colleagues. It asks children their level of agreement (from strongly agree to strongly disagree) with statements such as "it would be embarrassing to have a mental illness," "people with mental illness tend to be violent and dangerous," "schizophrenia is a mental disorder that involves multiple personalities," and "I would be frightened if a person with a mental illness approached me." High scores indicate greater knowledge and more positive attitudes. Regressed change is assessed by controlling pre-intervention values of the variable. Regressed change outcomes variables are 3 weeks post intervention, 6 months post intervention, 12 months post intervention, 18 months post intervention and 24 months post intervention.

    Assessed 3 weeks post-intervention, and then 6, 12, 18 and 24 months post intervention.

  • Changes in Help Seeking Behaviors

    Participants reported whether they had talked to 1) friends, 2) parents, 3) a doctor, 4) a therapist or whether they had 5) taken medication for a mental health problem. To gauge the intensity of help seeking an index was created that assigned a 4 to youths who either saw a therapist or took medications, a 3 to youths who talked to a doctor but did not see a therapist or take medication, a 2 to youths who talked to their parents but did not see a doctor, a therapist or take medication, a 1 to youths who talked to friends but engaged in none of the other help seeking behaviors and finally a 0 to youths who engaged in none of these help seeking behaviors. Regressed change is assessed by controlling pre-intervention values of the variable. Regressed change outcomes variables are 3 weeks post intervention, 6 months post intervention, 12 months post intervention, 18 months post intervention and 24 months post intervention.

    Assessed 3 weeks post-intervention, and then 6, 12, 18 and 24 months post intervention.

Secondary Outcomes (3)

  • Changes in Children's Social Distance Scale

    Assessed pre-intervention, 3 weeks post-intervention, and then 6, 12, 18 and 24 months post intervention.

  • Changes in Problem Behavior Frequency Aggression Scale

    Assessed 3 weeks post-intervention, and then 6, 12, 18 and 24 months post intervention.

  • Changes in Mental Health Problem Recognition

    Assessed 3 weeks post-intervention, and then 6, 12, 18 and 24 months post intervention.

Study Arms (8)

Curriculum

EXPERIMENTAL

Participants received only the curriculum intervention

Behavioral: Curriculum

Contact

ACTIVE COMPARATOR

Participants received only the contact intervention

Behavioral: Contact

Materials

ACTIVE COMPARATOR

Participants received only the materials intervention

Behavioral: Materials

Curriculum and Contact

EXPERIMENTAL

Participants received both curriculum and contact interventions

Behavioral: CurriculumBehavioral: Contact

Curriculum and Materials

EXPERIMENTAL

Participants received curriculum and materials interventions

Behavioral: CurriculumBehavioral: Materials

Contact and Materials

ACTIVE COMPARATOR

Participants received contact and materials intervention

Behavioral: ContactBehavioral: Materials

Curriculum, Contact and Materials

ACTIVE COMPARATOR

Participants received curriculum, contact and materials interventions

Behavioral: CurriculumBehavioral: ContactBehavioral: Materials

No intervention

NO INTERVENTION

Participants received no intervention

Interventions

CurriculumBEHAVIORAL

The curriculum intervention is a three- module, three-hour curriculum delivered by teachers in sixth grade classrooms over a three- to six-day period. The curriculum is designed to increase knowledge and improve attitudes about mental illnesses so as to improve the school climate with respect to mental illness stigma and encourage help seeking for youth in need.

Also known as: Eliminating the Stigma of Differences
CurriculumCurriculum and ContactCurriculum and MaterialsCurriculum, Contact and Materials
ContactBEHAVIORAL

The contact intervention involves two college students-a 27-year-old male with a history of bipolar I disorder and a 24-year-old female with a history of bipolar II disorder-who each make a ten-minute in-class presentation (20 minutes total) describing onset and course of their symptoms, hospitalizations and treatments, their feelings about the illness, coping strategies, and impact of the illness on social relationships and functioning at school and work.

ContactContact and MaterialsCurriculum and ContactCurriculum, Contact and Materials
MaterialsBEHAVIORAL

The materials intervention is implemented by teachers who prominently display posters in the classroom for two weeks and provide students with bookmarks. The materials focus on individuals' with mental illnesses emphasizing their personal traits and abilities as opposed to language that labels a person as "mentally ill."

Contact and MaterialsCurriculum and MaterialsCurriculum, Contact and MaterialsMaterials

Eligibility Criteria

Age10 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Sixth-grade students enrolled in required physical education/health classes at 14 participating schools in the Arlington, Texas School district.

You may not qualify if:

  • Sixth grade students who did not have caregiver's consent to participate.
  • Sixth grade students who did not give assent to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (13)

  • Corrigan P. How stigma interferes with mental health care. Am Psychol. 2004 Oct;59(7):614-625. doi: 10.1037/0003-066X.59.7.614.

    PMID: 15491256BACKGROUND
  • Corrigan PW, Larson JE, Michaels PJ, Buchholz BA, Rossi RD, Fontecchio MJ, Castro D, Gause M, Krzyzanowski R, Rusch N. Diminishing the self-stigma of mental illness by coming out proud. Psychiatry Res. 2015 Sep 30;229(1-2):148-54. doi: 10.1016/j.psychres.2015.07.053. Epub 2015 Jul 18.

    PMID: 26213379BACKGROUND
  • CRANDALL VC, CRANDALL VJ, KATKOVSKY W. A CHILDREN'S SOCIAL DESIRABILITY QUESTIONNAIRE. J Consult Psychol. 1965 Feb;29:27-36. doi: 10.1037/h0020966. No abstract available.

    PMID: 14277395BACKGROUND
  • Dusenbury L, Brannigan R, Falco M, Hansen WB. A review of research on fidelity of implementation: implications for drug abuse prevention in school settings. Health Educ Res. 2003 Apr;18(2):237-56. doi: 10.1093/her/18.2.237.

    PMID: 12729182BACKGROUND
  • Link BG, Struening EL, Neese-Todd S, Asmussen S, Phelan JC. Stigma as a barrier to recovery: The consequences of stigma for the self-esteem of people with mental illnesses. Psychiatr Serv. 2001 Dec;52(12):1621-6. doi: 10.1176/appi.ps.52.12.1621.

    PMID: 11726753BACKGROUND
  • Link BG, Yang LH, Phelan JC, Collins PY. Measuring mental illness stigma. Schizophr Bull. 2004;30(3):511-41. doi: 10.1093/oxfordjournals.schbul.a007098.

    PMID: 15631243BACKGROUND
  • Pullmann MD, Bruns EJ, Sather AK. Evaluating fidelity to the wraparound service model for youth: application of item response theory to the Wraparound Fidelity Index. Psychol Assess. 2013 Jun;25(2):583-98. doi: 10.1037/a0031864. Epub 2013 Apr 1.

    PMID: 23544392BACKGROUND
  • Raudenbush SW, Bryk AS. Hierarchical linear models: Applications and data analysis methods. Newbury Park, CA: Sage; 2002.

    BACKGROUND
  • Snijders TAB, Bosker R. Multilevel analysis. Thousand Oaks, CA: Sage; 1999.

    BACKGROUND
  • Wahl OF, Susin J, Kaplan L, Lax A, Zatina D. Changing Knowledge and Attitudes with a Middle School Mental Health Education Curriculum. Stigma Res Action. 2011;1(1):44-53. doi: 10.5463/sra.v1i1.17.

    PMID: 21731851BACKGROUND
  • West P, Sweeting H, Der G, Barton J, Lucas C. Voice-DISC identified DSM-IV disorders among 15-year-olds in the west of Scotland. J Am Acad Child Adolesc Psychiatry. 2003 Aug;42(8):941-9. doi: 10.1097/01.CHI.0000046907.27264.E4.

    PMID: 12874496BACKGROUND
  • Painter K, Phelan JC, DuPont-Reyes MJ, Barkin KF, Villatoro AP, Link BG. Evaluation of Antistigma Interventions With Sixth-Grade Students: A School-Based Field Experiment. Psychiatr Serv. 2017 Apr 1;68(4):345-352. doi: 10.1176/appi.ps.201600052. Epub 2016 Nov 15.

  • Link BG, DuPont-Reyes MJ, Barkin K, Villatoro AP, Phelan JC, Painter K. A School-Based Intervention for Mental Illness Stigma: A Cluster Randomized Trial. Pediatrics. 2020 Jun;145(6):e20190780. doi: 10.1542/peds.2019-0780. Epub 2020 May 20.

MeSH Terms

Conditions

Social StigmaMental Disorders

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcomes were self-reported and completed on lap top computers without interaction with assessors. Research staff conducting home visits were not aware of which arm participants received.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
FACTORIAL
Model Details: A two by two by two cluster randomized fully -crossed factorial design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Distinguished Professor of Public Policy

Study Record Dates

First Submitted

June 27, 2018

First Posted

July 24, 2018

Study Start

July 1, 2011

Primary Completion

June 30, 2015

Study Completion

June 30, 2015

Last Updated

July 24, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share