Primary Care Internet Based Depression Prevention for Adolescents (CATCH-IT) Also Known as Promoting AdolescenT Health (CATCH-IT)
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| ClinicalTrials.gov Identifier: NCT01893749 |
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Recruitment Status
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Completed
First Posted
: July 9, 2013
Last Update Posted
: November 2, 2016
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Major Depression Depressive Episodes | Behavioral: CATCH-IT | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 1142 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Outcomes Assessor) |
| Primary Purpose: | Prevention |
| Official Title: | Primary Care Internet Based Depression Prevention for Adolescents (Promoting AdolescenT Health-PATH) |
| Study Start Date : | February 2012 |
| Actual Primary Completion Date : | July 2016 |
| Actual Study Completion Date : | July 2016 |
| Arm | Intervention/treatment |
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Experimental: CATCH-IT
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. |
Behavioral: CATCH-IT
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.
Other Names:
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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. |
- The Center for Epidemiological Studies of Depression(CES-D)Scale [ Time Frame: 0, 2, 6, 12, 18 and 24 months ]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 ]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 ]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 ]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 ]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 ]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 ]assesses age, height, weight, contact information, race, ethnicity, home demographics, educational level of parents.
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| Ages Eligible for Study: | 13 Years to 18 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01893749
| United States, Illinois | |
| ACCESS Healthcare Systems | |
| Chicago, Illinois, United States, 60606 | |
| University of Illinois | |
| Chicago, Illinois, United States, 60612 | |
| Northshore Healthcare Systems | |
| Evanston, Illinois, United States, 60201 | |
| Advocate Health Care | |
| Oak Lawn, Illinois, United States, 60453 | |
| Children's Clinic | |
| Oak Park, Illinois, United States, 60302 | |
| United States, Indiana | |
| Franciscan St. Margaret Health | |
| Dyer, Indiana, United States, 46311 | |
| United States, Massachusetts | |
| Wellesley Center for Women | |
| Wellesley, Massachusetts, United States, 02481-8203 | |
| Principal Investigator: | Benjamin Van Voorhees, MD, MPH | UIC | |
| Principal Investigator: | Tracy Gladstone, PHD | Wellesley Center for Women |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Benjamin Van Voorhees, MD, MPH, Associate Professor of Medicine, Chief, Section of General Pediatrics and Adolescent Medicine, TIKES Center Director, University of Illinois at Chicago |
| ClinicalTrials.gov Identifier: | NCT01893749 History of Changes |
| Other Study ID Numbers: |
1R01MH090035-01A1 ( U.S. NIH Grant/Contract ) |
| First Posted: | July 9, 2013 Key Record Dates |
| Last Update Posted: | November 2, 2016 |
| Last Verified: | October 2016 |
Keywords provided by Benjamin Van Voorhees, MD, MPH, University of Illinois at Chicago:
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depression prevention teen at risk internet |
Additional relevant MeSH terms:
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Depression Depressive Disorder Depressive Disorder, Major |
Behavioral Symptoms Mood Disorders Mental Disorders |