Clinical trial NCT01893749: Primary Care Internet Based Depression Prevention for Adolescents (CATCH-IT) Also Known as Promoting AdolescenT Health
Official title: Primary Care Internet Based Depression Prevention for Adolescents (Promoting AdolescenT Health-PATH)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depression
Depressive Episodes
Keywords: depression
prevention
teen
at risk
internet
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: Wellesley College
name: Northwestern University
name: Harvard Vanguard Medical Associates
name: Access Healthcare Systems
name: Endeavor Health
name: Infant Welfare Society
name: Wake Forest University Health Sciences
name: Franciscan St. Margaret Health - Franciscan Alliance
First posted: 2013-07-09
Enrollment: 1142
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Major Depressive Episode (major and sub-threshold)
timeFrame: 0, 2, 6, 12, 18 and 24 months
Secondary outcomes:
measure: Depressed mood
timeFrame: 0, 2, 6, 12, 24 months
measure: Vulnerability Factors
timeFrame: 0, 2, 6, 12, 18, 24 months
measure: Quality of Life, educational impairment and other mental disorder symptoms or episodes
timeFrame: 0, 2, 6, 12, 18, 24 months
Other outcomes:
measure: Adherence to Internet Use
timeFrame: continous measure
measure: Implementation
timeFrame: 0, 2, 24 months
measure: Motivation (adolescent)
timeFrame: 0,2,12 months
measure: Demographic Information
timeFrame: 0,2,6,12,24 months
Locations:
city: Chicago
country: United States
facility: ACCESS Healthcare Systems
state: Illinois
city: Chicago
country: United States
facility: University of Illinois
state: Illinois
city: Evanston
country: United States
facility: Northshore Healthcare Systems
state: Illinois
city: Oak Lawn
country: United States
facility: Advocate Health Care
state: Illinois
city: Oak Park
country: United States
facility: Children's Clinic
state: Illinois
city: Dyer
country: United States
facility: Franciscan St. Margaret Health
state: Indiana
city: Wellesley
country: United States
facility: Wellesley Center for Women
state: Massachusetts
Study officials:
affiliation: UIC
name: Benjamin Van Voorhees, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Wellesley Center for Women
name: Tracy Gladstone, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Van Voorhees B, Gladstone TRG, Sobowale K, Brown CH, Aaby DA, Terrizzi DA, Canel J, Ching E, Berry AD, Cantorna J, Eder M, Beardslee W, Fitzgibbon M, Marko-Holguin M, Schiffer L, Lee M, de Forest SA, Sykes EE, Suor JH, Crawford TJ, Burkhouse KL, Goodwin BC, Bell C. 24-Month Outcomes of Primary Care Web-Based Depression Prevention Intervention in Adolescents: Randomized Clinical Trial. J Med Internet Res. 2020 Oct 28;22(10):e16802. doi: 10.2196/16802.
citation: Gladstone T, Buchholz KR, Fitzgibbon M, Schiffer L, Lee M, Voorhees BWV. Randomized Clinical Trial of an Internet-Based Adolescent Depression Prevention Intervention in Primary Care: Internalizing Symptom Outcomes. Int J Environ Res Public Health. 2020 Oct 22;17(21):7736. doi: 10.3390/ijerph17217736.
citation: Gladstone TG, Marko-Holguin M, Rothberg P, Nidetz J, Diehl A, DeFrino DT, Harris M, Ching E, Eder M, Canel J, Bell C, Beardslee WR, Brown CH, Griffiths K, Van Voorhees BW. An internet-based adolescent depression preventive intervention: study protocol for a randomized control trial. Trials. 2015 May 1;16:203. doi: 10.1186/s13063-015-0705-2.