Primary Care Internet Based Depression Prevention for Adolescents (CATCH-IT) Also Known as Promoting AdolescenT Health
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Primary Care Internet Based Depression Prevention for Adolescents (Promoting AdolescenT Health-PATH)|
- The Center for Epidemiological Studies of Depression(CES-D)Scale [ Time Frame: 0, 2, 6, 12, 18 and 24 months ] [ Designated as safety issue: Yes ]Change in CES-D score from baseline Change in CES-D score between groups (CATCH-IT & HEALTHED)across the duration of the study and for each assessment point
- Kiddie Schedule of Affective Disorders Scale(KSADS) [ Time Frame: 0, 2, 6, 12, 24 months ] [ Designated as safety issue: Yes ]Screening for current and past psychiatric diagnosis at each time point to ensure eligibility is consistent throughout the study (certain psychiatric diagnosis might render a subject ineligible for the study, therefore a KSADS interview is conducted at each major assessment point)
- Vulnerability Factors [ Time Frame: 0, 2, 6, 12, 18, 24 months ] [ Designated as safety issue: No ]Change in scales of SCARED, Disruptive Behavior Disorder Scale (DBD - teen and parent), CRAFFT, Sibling Relationship Questionnaire (SRQ - teen and parent), Sibling Inventory of Differential Experience, (SIDE), Child/Parent Report of Parental Behavior Inventory (CRPBI - teen and parent), Conflict Behavior Questionnaire (CBQ - teen and parent), Physician Relationship Scale, Pediatric Quality of Life and Enjoyment and Satisfaction Questionnaire (teen and parent), Masten's Status Questionnaire, Theory of Planned Behavior Scale, Trans-Theoretical Model Scale, Beck Hopelessness Scale (BHS), Teen Behavior Questionnaire (TBS), Social Adjustment Scare (SAS-SR), Adolescent Life Events Questionnaire (ALEQ). Not all measures are used at all timepoints. As needed based on suicidal presentation at a given timepoint, safety measures are also obtained (Suicide Ideation Scale, Suicide Intent Scale, Lethality Scale).
- Adherence to Internet Use [ Time Frame: continous measure ] [ Designated as safety issue: No ]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.
- Implementation [ Time Frame: 0, 2, 24 months ] [ Designated as safety issue: No ]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.
- Motivational Interview Pre-Measure [ Time Frame: 0,2,12 months ] [ Designated as safety issue: No ]This measure is administered to adolescents prior to meeting with the physician for a motivational interview. It contains items asking adolescents to identify goals for the intervention, consider how they are feeling and their degree of motivation to change their feelings, and their willingness to engage in the present intervention. This is an optional measure
- Demographic Information [ Time Frame: 0,2,6,12,24 months ] [ Designated as safety issue: No ]assesses age, height, weight, contact information, race, ethnicity, home demographics, educational level of parents.
|Study Start Date:||February 2012|
|Estimated Study Completion Date:||September 2017|
|Estimated Primary Completion Date:||September 2015 (Final data collection date for primary outcome measure)|
200 randomized teens 13-18 year old (inclusive) will be enrolled into the online program that contains 14 modules focused various therapeutic techniques, a booster session of 6 modules at the end of the online program and three 15 minute visits with their primary care doctor to discuss the benefits and disadvantages of the program.
Parents will also be invited to participant in a partnering online program involving 4 modules online and 1 optional module. They will be asked to then participate in three 15 minute interviews with a member of the study team to discuss the benefits and disadvantages of the program.
It contains 14 modules focused on behavioral activation, cognitive behavioral therapy, interpersonal therapy and a resiliency building model, including elements such as narratives, video diaries, skill building exercises and a booster program (not yet initiated) with 6 modules that involves interaction with a live therapist. It also includes three 15-minute meetings with the primary care provider at baseline, 2 months and 12 months post intervention. These meetings are focused on the motivational interview approach where the patient and the doctor talk about the mental/physical health goals of the patient and determine the best approach for the patient by allowing the patient to have full input into the plan.
No Intervention: Health Education
200 randomized teens, ages 13-18 year old (inclusive) receiving an online program with 14 modules that focus on general health education, depression, diet, exercise, hygiene and safety.
Parents will also be invited to participate in an online program with 4 modules that also focus on general health education.
Additional aims and hypothesis are provided below:
-Aim 1: To determine whether the CATCH-IT depression prevention intervention prevents or delays major depressive episodes, as well as non-affective disorder episodes, compared to HEALTH EDUCATION.
Hypothesis 1: Compared to youth in the HEALTH EDUCATION condition, youth assigned to CATCH-IT will have a lower hazard ratio of major depressive episodes and non-affective disorder episodes over 2 years.
-Aim 2: To determine if participants in the CATCH-IT group exhibit more rapid favorable changes of depressive symptoms/and or vulnerability/protective factors compared to the HEALTH EDUCATION group.
Hypothesis 2: Compared to youth in the HEALTH EDUCATION condition, youth in the CATCH-IT program will demonstrate a steeper slope of improved symptoms and fewer depressed days over 2 years.
-Aim 3: To determine if participants in the CATCH-IT program report lower perceived educational impairment, greater quality of life, greater health-related quality of life, and lower incidence of other mental disorders (anxiety, substance/alcohol use) as compared to participants in HEALTH EDUCATION.
Hypothesis 3: Compared to youth in the HEALTH EDUCATION group, youth in the CATCH-IT program will demonstrate more rapid benefits in reduced educational impairment, improved quality of life, and fewer disorders over 2 years.
-Aim 4: To determine for whom (moderators)among 13-18 year old (inclusive) and how (mediators) the CATCH-IT program works.
Hypothesis 4.1: CATCH-IT effects will be moderated by six domains: (1) demographic/cultural factors, (2) vulnerability factors/adverse events,(3) motivation,(4) physician relationship, (5) parent/child co-morbid psychopathology, and (6) treatment.
Hypothesis 4.2: The relation between CATCH-IT participation and reduction in depressive episodes will be mediated by adherence to the Internet, motivational interview fidelity as they alter vulnerability factors (e.g. motivation, cognition and social support) and responses to adverse events, which in turn impact the likelihood of episodes.
Exploratory Aim 1: To determine the implementation feasibility of the intervention from the physician/nurse practitioner and office nurse/medical assistant perspective as well as to describe the practices in relationship to the medical home model.
Exploratory Aim 2: To determine whether CATCH-IT has a favorable cost-benefit ratio and/or cost effectiveness of <$50,000/disability adjusted life year compared to the HEALTH EDUCATION group.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01893749
|Contact: Benjamin VanVoorhees, MD/MPHemail@example.com|
|Contact: Monika Marko, MSSfirstname.lastname@example.org|
|United States, Illinois|
|ACCESS Healthcare Systems||Recruiting|
|Chicago, Illinois, United States, 60606|
|Contact: Benjamin VanVoorhees, MD/MPH 312-996-0023 email@example.com|
|University of Illinois||Recruiting|
|Chicago, Illinois, United States, 60612|
|Contact: Monika Marko, MSS 312-413-1165 firstname.lastname@example.org|
|Sub-Investigator: Florence Desrosiers, MD|
|Northshore Healthcare Systems||Recruiting|
|Evanston, Illinois, United States, 60201|
|Contact: Jennifer Nidetz, MSW, LCSW 312-996-0407 email@example.com|
|Sub-Investigator: Jason Canel, MD|
|Advocate Health Care||Recruiting|
|Oak Lawn, Illinois, United States, 60453|
|Contact: Anita Berry, CNP,APN,PMHS 630-929-6663 firstname.lastname@example.org|
|Principal Investigator: Anita Berry, CNP,APN,PMHS|
|Oak Park, Illinois, United States, 60302|
|Contact: Elizabeth Lippitt email@example.com|
|Principal Investigator: Benjamin Van Voorhees, MD, MPH|
|United States, Indiana|
|Franciscan St. Margaret Health||Recruiting|
|Dyer, Indiana, United States, 46311|
|Contact: James Cantorna, MD 219-924-6544 James.Cantorna@franciscanalliance.org|
|United States, Massachusetts|
|Wellesley Center for Women||Recruiting|
|Wellesley, Massachusetts, United States, 02481-8203|
|Contact: Tracy Gladstone, PHD 781-283-2558 firstname.lastname@example.org|
|Principal Investigator: Tracy Gladstone, PHD|
|Principal Investigator:||Benjamin Van Voorhees, MD, MPH||UIC|
|Principal Investigator:||Tracy Gladstone, PHD||Wellesley Center for Women|