Major Depression Clinical Trial
— CATCH-ITOfficial title:
Primary Care Internet Based Depression Prevention for Adolescents (Promoting AdolescenT Health-PATH)
Verified date | August 2019 |
Source | University of Illinois at Chicago |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this randomized multiple-site clinical study is to determine whether a revised CATCH-IT (Internet-based depression prevention program) is more effective than a general health education Internet intervention (Health Education)on teens ages 13-18 (inclusive). It is hypothesized that teens in CATCH-IT will exhibit lower levels of depressed mood and/or maintain lower depressive scores over 2 years long-term follow up as compared to teens in Health Education group.
Status | Completed |
Enrollment | 1142 |
Est. completion date | July 2016 |
Est. primary completion date | July 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 13 Years to 18 Years |
Eligibility |
Inclusion Criteria: Adolescents: (A) Youth ages 13 through 18 who are English speaking. (B) Youth must be experiencing elevated level of depressive symptoms on the Center for Epidemiologic Studies Depression (CES-D) scale (score >/= 16). (C) Youth will be included if they have a past history of depression, anxiety, externalizing symptoms, or substance abuse. Youth presenting in partial remission from a major depressive episode at Baseline will be rescreened after 2 months utilizing the phone screen to ensure episode is fully remitted prior to randomization or access to study intervention. Those who do not fully remit after two months will be excluded. Parents: *Parent of eligible adolescents Physicians (PCP) or NP: *Physician in any of the study sites Healthcare Professionals: *Primary care practice for a minimum of 6 months Exclusion Criteria: Adolescents: - Current DSM-IV diagnosis of Major Depressive Disorder - Current therapy for depression, or be taking antidepressants (e.g., SSRIs, TCAs, MAOIs, bupropion, nefazodone, mirtazapine, venlafaxine); - Current CES-D score >35; - DSM-IV diagnosis of schizophrenia (current or past) or bipolar affective disorder; - Current serious medical illness that causes significant disability or dysfunction; - Significant reading impairment (a minimum sixth-grade reading level based on parental report), mental retardation, or developmental disabilities; - Serious imminent suicidal risk (as determined by endorsement of current suicide on CES-D or in KSADS interview) or other conditions that may require immediate psychiatric hospitalization - Psychotic features or disorders, or currently be receiving psychotropic medication - Extreme, current drug/alcohol abuse (greater than or equal to 2 on the CRAFFT). Parents: - Ineligible child - Non-English speaking Physicians: *None Healthcare Professionals: *None |
Country | Name | City | State |
---|---|---|---|
United States | ACCESS Healthcare Systems | Chicago | Illinois |
United States | University of Illinois | Chicago | Illinois |
United States | Franciscan St. Margaret Health | Dyer | Indiana |
United States | Northshore Healthcare Systems | Evanston | Illinois |
United States | Advocate Health Care | Oak Lawn | Illinois |
United States | Children's Clinic | Oak Park | Illinois |
United States | Wellesley Center for Women | Wellesley | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Benjamin Van Voorhees, MD, MPH | Access Healthcare Systems, Advocate Health Care, Franciscan St. Margaret Health - Franciscan Alliance, Harvard Vanguard Medical Associates, Infant Welfare Society, NorthShore University HealthSystem, Northwestern University, Wellesley College |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Adherence to Internet Use | Counting the number of logs/subject (over 2 years), number of characters typed, number of clicks in each page, time spent on each session and total time spent online and Socio-cultural Relevance Scale. | continous measure | |
Other | Implementation | Changes in perceived feasibility and implementation of the study from the healthcare professionals (physicians, nurse and leaders)from baseline to the completion of the study at 24 months. | 0, 2, 24 months | |
Other | Motivation (adolescent) | Theory of Planned Behavior Scale, Trans-Theoretical Model Scale | 0,2,12 months | |
Other | Demographic Information | assesses age, height, weight, contact information, race, ethnicity, home demographics, educational level of parents. | 0,2,6,12,24 months | |
Primary | Major Depressive Episode (major and sub-threshold) | Kiddie Schedule of Affective Disorders Scale (KSADS) used to evaluate for current and past depressive episode at each time point (interval between time points). Occurrence of first depressive episode was determined by the Depression Symptom Rating (DSR). We considered a score indicating at least sub-threshold major depression (a DSR of =3+) to be a depressive episode. DSR 4 and above and 5 alone will also be assessed. | 0, 2, 6, 12, 18 and 24 months | |
Secondary | Depressed mood | The Center for Epidemiological Studies of Depression(CES-D)Scale -Change in CES-D score between groups (CATCH-IT & HEALTHED) across the duration of the study and for each assessment point | 0, 2, 6, 12, 24 months | |
Secondary | Vulnerability Factors | Sibling Inventory of Differential Experience, (SIDE), Child/Parent Report of Parental Behavior Inventory (CRPBI - teen and parent), Conflict Behavior Questionnaire (CBQ - teen and parent), Beck Hopelessness Scale, Adolescent Life Events Questionnaire (ALEQ) (not all measures at all time points) | 0, 2, 6, 12, 18, 24 months | |
Secondary | Quality of Life, educational impairment and other mental disorder symptoms or episodes | Masten's Status Questionnaire,World Health Organization (WHO) Quality of Life Scale , Educational Impairment Scale, Change in scales of SCARED, Disruptive Behavior Disorder Scale (DBD - teen and parent), CRAFFT (substance abuse), SCARED (anxiety), Global Assessment Scale (GAS, assessor scores from KSADS responses) scores (not all measures at all time points). | 0, 2, 6, 12, 18, 24 months |
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