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Randomized, School-based Effectiveness Trial of the Adolescent Depression Awareness Program (ADAP)

Primary Purpose

Adolescent - Emotional Problem, Depression, Prevention Harmful Effects

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Adolescent Depression Awareness Program (ADAP)
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Adolescent - Emotional Problem focused on measuring Adolescent; Depression, Early intervention (education), Randomized Controlled Trial, Primary Prevention, schools, Health Literacy, Discrimination (Psychology), Mental Health Services

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • enrolled in one of the participating schools parental consent and student assent is required for the web-based survey

Exclusion Criteria:

  • not enrolled in the participating schools

Sites / Locations

  • Johns Hopkins University
  • Johns Hopkins

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Wait list control

Arm Description

Receive Adolescent Depression Awareness Program (ADAP) intervention

no intervention

Outcomes

Primary Outcome Measures

Adolescent Depression Knowledge Questionnaire (ADKQ)
The Adolescent Depression Knowledge Questionnaire (ADKQ) will be used to assess depression literacy

Secondary Outcome Measures

Reported and Intended Behaviour Scale (RIBS)
The Reported and Intended Behaviour Scale (RIBS) will be used to assess mental health stigma.

Full Information

First Posted
March 20, 2014
Last Updated
June 8, 2017
Sponsor
Johns Hopkins University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT02099305
Brief Title
Randomized, School-based Effectiveness Trial of the Adolescent Depression Awareness Program
Acronym
ADAP
Official Title
Impact of Increasing Adolescent Depression Literacy on Treatment-Seeking Behavior
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johns Hopkins University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary goal of the proposed research is to assess the effectiveness of the Adolescent Depression Awareness Program (ADAP), a school-based depression education program, in increasing depression literacy and treatment seeking in high school students. The ADAP intervention will be carried out in approximately 60 schools with over 15,000 students. The following are ADAP Implementation Sites: Baltimore Archdiocese High Schools; New Castle County, Delaware; Washtenaw County, Michigan; and York County, Pennsylvania.
Detailed Description
The primary goal of the proposed research is to assess the effectiveness of the Adolescent Depression Awareness Program (ADAP), a school-based depression education program, in increasing depression literacy and treatment seeking. This proposal will have broad reach as the intervention will be carried out in 66 schools with over 15,000 students. The lifetime prevalence of Major Depressive Disorder (MDD) in the United States is high, ranging from 15% to 17%. Its usual symptom onset occurs early in life, during teen or young adult years. It has been estimated that 8.5% of youth ages 12 to 17 (over 2 million adolescents) experienced at least one Major Depressive Episode in the past year (SAMHSA Office of Applied Studies, 2008). Nearly half (48.3%) of these youth reported severe impairment in at least one of four major role domains (home, school/work, family relationships, or social life). The onset of depression during adolescence is associated with increased risks for educational underachievement, unemployment, early parenthood, substance dependence, anxiety disorders, and recurrent major depression during early adulthood (Fergusson & Woodward, 2002). The most severe consequence of untreated depression is suicide. Psychological autopsy studies of adolescent suicides have reported that upwards of 90% had at least one psychiatric disorder at the time of their death, most notably depression (Marttunen et al., 1990; Brent et al., 1993; Shaffer et al., 1996). From a developmental perspective, the prevention and treatment of depression during adolescence can provide lifelong benefits. Effective treatments for adolescent depression are available (TADS, 2007); however, adolescents in need of treatment are often not recognized by parents, teachers, or peers. The National Comorbidity Study-Replication estimated a median delay of 8 years between the onset of depressive symptoms and receiving treatment (Wang et al., 2006). The early identification of depression leading to effective treatment can help address the morbidity and mortality associated with adolescent depression. Despite the importance of adolescent depression, there have been few large-scale randomized trials investigating the effectiveness of universal interventions targeting depression among adolescents. ADAP is a 3-hour high school-based curriculum, proposed herein to be delivered as part of the standard high school health education curriculum, aimed at improving depression literacy. The mission of ADAP is to educate high school students, teachers, and parents about teenage unipolar and bipolar depression (Hess et al., 2004). The core message of ADAP is that "depression is a treatable medical illness." ADAP was developed in 1999 by a team of psychiatrists and psychiatric nurses from the Johns Hopkins University School of Medicine. In the past decade, ADAP has been implemented in over 85 schools with over 20,000 students throughout the United States. Previously published research evaluating ADAP described a significant improvement in adolescents' knowledge about depression after receiving the curriculum using a one group pretest/posttest design (Swartz et al., 2008). Recently, in Tulsa, Oklahoma, comparison schools were included, and it was found that the proportion of students achieving "depression literacy" (scoring 80% or higher on our knowledge assessment) more than tripled from pretest to posttest (Leon et al., in review) in the ADAP group. To date, a randomized design has not been employed and the impact of ADAP on treatment seeking behaviors has not been studied. Both of these issues are important to address before ADAP can be routinely integrated into high school health education curricula. The specific aims of this proposal are as follows: Specific Aim 1: To assess the effectiveness of ADAP, a school-based depression education program, in increasing depression literacy. 1.1 To assess depression literacy changes following the intervention, as compared to the standard health education curriculum, with a post-test at 6 weeks post intervention. 1.2 To assess the sustainability of depression literacy changes with a post-test at 4 months post ADAP. Specific Aim 2: To assess whether the ADAP intervention, as compared to the standard health curriculum, has an influence on treatment seeking behaviors in high school students, as measured by an increase in visits to school counselors and self-reported treatment seeking. 2.1 To track mental health help-seeking and the receipt of mental health services pre and post ADAP in a subset of schools (28 schools in York County Pennsylvania and St. Francis Indian School on the Rosebud Indian Reservation served by the Indian Health Service). 2.2 To track mental health visits to school counselors in aggregate pre and post ADAP in all 66 participating schools. Specific Aim 3: To identify possible mediators (e.g., fidelity) and moderators of intervention impact (e.g., access to community mental health services, teacher characteristics, school characteristics, parental participation in the community forum; stigma).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adolescent - Emotional Problem, Depression, Prevention Harmful Effects
Keywords
Adolescent; Depression, Early intervention (education), Randomized Controlled Trial, Primary Prevention, schools, Health Literacy, Discrimination (Psychology), Mental Health Services

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
17000 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Receive Adolescent Depression Awareness Program (ADAP) intervention
Arm Title
Wait list control
Arm Type
No Intervention
Arm Description
no intervention
Intervention Type
Other
Intervention Name(s)
Adolescent Depression Awareness Program (ADAP)
Other Intervention Name(s)
ADAP
Intervention Description
Depression education curriculum delivered by trained school health education teachers or other school personnel
Primary Outcome Measure Information:
Title
Adolescent Depression Knowledge Questionnaire (ADKQ)
Description
The Adolescent Depression Knowledge Questionnaire (ADKQ) will be used to assess depression literacy
Time Frame
Change from pretest (directly before intervention) to post-test (6 weeks after ADAP). We will see if this is sustained 4 months after ADAP.
Secondary Outcome Measure Information:
Title
Reported and Intended Behaviour Scale (RIBS)
Description
The Reported and Intended Behaviour Scale (RIBS) will be used to assess mental health stigma.
Time Frame
Change from pretest (directly before intervention) to post-test (6 weeks after ADAP). We will see if this is sustained 4 months after ADAP.
Other Pre-specified Outcome Measures:
Title
Help-seeking and the receipt of Mental Health Services
Description
We have designed a web-based survey in RedCAP to assess help-seeking and the receipt of Mental Health Services, barriers and attitudes, and other issues among students in York County, Pennsylvania with parental consent.
Time Frame
after the ADAP intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: enrolled in one of the participating schools parental consent and student assent is required for the web-based survey Exclusion Criteria: not enrolled in the participating schools
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Holly C. Wilcox, PhD
Organizational Affiliation
Associate Professor, Johns Hopkins School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Karen Swartz, MD
Organizational Affiliation
Johns Hopkins School of Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23790814
Citation
Ruble AE, Leon PJ, Gilley-Hensley L, Hess SG, Swartz KL. Depression knowledge in high school students: effectiveness of the adolescent depression awareness program. J Affect Disord. 2013 Sep 25;150(3):1025-30. doi: 10.1016/j.jad.2013.05.033. Epub 2013 Jun 18.
Results Reference
result
PubMed Identifier
17652614
Citation
Swartz KL, Kastelic EA, Hess SG, Cox TS, Gonzales LC, Mink SP, DePaulo JR Jr. The effectiveness of a school-based adolescent depression education program. Health Educ Behav. 2010 Feb;37(1):11-22. doi: 10.1177/1090198107303313. Epub 2007 Jul 25.
Results Reference
result
PubMed Identifier
15625662
Citation
Hess SG, Cox TS, Gonzales LC, Kastelic EA, Mink SP, Rose LE, Swartz KL. A survey of adolescents' knowledge about depression. Arch Psychiatr Nurs. 2004 Dec;18(6):228-34. doi: 10.1016/j.apnu.2004.09.005.
Results Reference
result
PubMed Identifier
30612807
Citation
Townsend L, Musci R, Stuart E, Heley K, Beaudry MB, Schweizer B, Ruble A, Swartz K, Wilcox H. Gender Differences in Depression Literacy and Stigma After a Randomized Controlled Evaluation of a Universal Depression Education Program. J Adolesc Health. 2019 Apr;64(4):472-477. doi: 10.1016/j.jadohealth.2018.10.298. Epub 2019 Jan 4.
Results Reference
derived
PubMed Identifier
29048969
Citation
Swartz K, Musci RJ, Beaudry MB, Heley K, Miller L, Alfes C, Townsend L, Thornicroft G, Wilcox HC. School-Based Curriculum to Improve Depression Literacy Among US Secondary School Students: A Randomized Effectiveness Trial. Am J Public Health. 2017 Dec;107(12):1970-1976. doi: 10.2105/AJPH.2017.304088. Epub 2017 Oct 19.
Results Reference
derived
Links:
URL
http://www.hopkinsmedicine.org/psychiatry/specialty_areas/moods/ADAP/
Description
Adolescent Depression Awareness Program (ADAP) website

Learn more about this trial

Randomized, School-based Effectiveness Trial of the Adolescent Depression Awareness Program

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