Adolescent - Emotional ProblemADAPNCT02099305
Randomized, School-based Effectiveness Trial of the Adolescent Depression Awareness Program
A study testing Adolescent Depression Awareness Program (ADAP) in people with Adolescent - Emotional Problem and Depression, run by Johns Hopkins University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Adolescent - Emotional Problem, Depression, Prevention Harmful Effects
- What is being tested?
- Adolescent Depression Awareness Program (ADAP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17,000 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2012to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- enrolled in one of the participating schools parental consent and student assent is required for the web-based survey
Who cannot join
- not enrolled in the participating schools
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins University
Baltimore, Maryland, 21205
Johns Hopkins
Baltimore, Maryland, 21205
About this study
Official title: Impact of Increasing Adolescent Depression Literacy on Treatment-Seeking Behavior
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.
Read the 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).
- Being tested
- Adolescent Depression Awareness Program (ADAP)
- Keywords
- Adolescent; Depression, Early intervention (education), Randomized Controlled Trial, Primary Prevention, schools, Health Literacy, Discrimination (Psychology), Mental Health Services
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adolescent Depression Awareness Program (ADAP)Other
Also called ADAP
Depression education curriculum delivered by trained school health education teachers or other school personnel
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Receive Adolescent Depression Awareness Program (ADAP) intervention Receives: Other: Adolescent Depression Awareness Program (ADAP) |
| Wait list control | No intervention | no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adolescent Depression Knowledge Questionnaire (ADKQ)
The Adolescent Depression Knowledge Questionnaire (ADKQ) will be used to assess depression literacy
Measured: 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 outcomes (1)
Reported and Intended Behaviour Scale (RIBS)
The Reported and Intended Behaviour Scale (RIBS) will be used to assess mental health stigma.
Measured: Change from pretest (directly before intervention) to post-test (6 weeks after ADAP). We will see if this is sustained 4 months after ADAP.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2014 (estimated)
- Study startSep 2012
- Primary completionMay 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Adolescent - Emotional ProblemStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 17,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Holly C. wilcox, Johns Hopkins University
- Investigators
- Holly C. Wilcox, PhD, Principal investigator, Associate Professor, Johns Hopkins School of MedicineKaren Swartz, MD, Study chair, Johns Hopkins School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02099305
- Sponsor's protocol ID
- 1-wilcox
- Other IDs
- R01MH095855
- Acronym
- ADAP
- Status last verified
- Mar 2016
- First submitted
- 20 Mar 2014
- Last updated
- 12 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23790814Swartz 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.
PubMed 17652614Hess 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.
PubMed 15625662Townsend 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.
PubMed 30612807Swartz 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.
PubMed 29048969
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Increasing Adolescent Depression Literacy on Treatment-Seeking Behavior
- ClinicalTrials.gov ID
- NCT02099305
- Acronym / sponsor ID
- ADAP / 1-wilcox
- Keywords
- Adolescent; Depression, Early intervention (education), Randomized Controlled Trial, Primary Prevention, schools, Health Literacy, Discrimination (Psychology), Mental Health Services
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17,000 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Sep 2012
- Primary completion
- May 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 28 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Adolescent Depression Awareness Program (ADAP)Receive Adolescent Depression Awareness Program (ADAP) intervention |
| Wait list control | No intervention | –no intervention |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- enrolled in one of the participating schools parental consent and student assent is required for the web-based survey
Key exclusion criteria (1 listed)
- not enrolled in the participating schools
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adolescent Depression Awareness Program (ADAP)Also: ADAPDepression education curriculum delivered by trained school health education teachers or other school personnel | Other | Intervention |
Primary outcome
Adolescent Depression Knowledge Questionnaire (ADKQ)
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.
The Adolescent Depression Knowledge Questionnaire (ADKQ) will be used to assess depression literacy
1 secondary outcome
Reported and Intended Behaviour Scale (RIBS)
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2017.
- Results publication: PubMed 23790814Ruble 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 publication: PubMed 17652614Swartz 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 publication: PubMed 15625662Hess 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.
- Derived from this study: PubMed 30612807Townsend 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.
- Derived from this study: PubMed 29048969Swartz 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.
- Adolescent Depression Awareness Program (ADAP) websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Holly C. Wilcox, PhD principal investigator
Associate Professor, Johns Hopkins School of Medicine
Karen Swartz, MD study chair
Johns Hopkins School of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adolescent Depression Awareness Program (ADAP) in people with Adolescent - Emotional Problem and Depression, run by Johns Hopkins University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adolescent Depression Knowledge Questionnaire (ADKQ) (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02099305, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2017.