Process and Outcomes in CBT for Anxious and Depressed Youth
NCT03100279, Not applicable, Completed, Rutgers University
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Process and Outcomes in CBT for Anxious and Depressed Youth | ClinicalTrials.gov |
| NCT number | NCT03100279 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 247 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Rutgers University | ClinicalTrials.gov |
| Conditions | Anxiety Disorders, Depression | ClinicalTrials.gov |
| Interventions | Coping Cat/CAT Project, Primary and Secondary Coping Enhancement Therapy | ClinicalTrials.gov |
| First posted | 2017-04-04 | ClinicalTrials.gov |
| Last updated | 2026-07-17 | ClinicalTrials.gov |
Registered outcomes 41
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change in Clinical Global Impression - Severity (CGI-S) Scale: interviewer | Change from pre-treatment to post-treatment (an average of 16 weeks) | The CGI-S score provides a global rating of baseline severity ranging from 1 (not at all ill) to 7 (extremely ill). The IE will provide a baseline CGI ratings for each patient at pretreatment and posttreatment. | ClinicalTrials.gov |
| Secondary | Change in Anxiety Disorders Interview Schedule (ADIS-IV) - Principal Diagnosis | Change from pre-treatment to post-treatment (an average of 16 weeks) | The ADIS-C/P (Silverman \& Albano, 1996) is a semi-structured interview consisting of independent but comparable parent and child interviews that have good interviewer reliability (e.g., k= .98, parent interview; k=.93, child interview; Silverman \& Nelles, 1988), retest reliability (i.e., r=.76, parent interview; Silverman \& Eisen, 1992), and sensitivity to treatment effects (e.g., Albano, Know, \& Barlow, 1995; Kendall et al., 1997). The parent and child interviews are conducted individually allowing the diagnostician to derive parent-reported, child-reported, and composite (parent and child) diagnoses. Diagnosticians will be trained to reliability by shadowing trained interviewers, being shadowed by a trained interviewer, and by coding videotaped interviews and matching gold-standard ratings of diagnoses. | ClinicalTrials.gov |
| Secondary | Change in Children's Depression Rating Scale-Revised (CDRS-R): Total depression score | Change from pre-treatment to post-treatment (an average of 16 weeks) | Clinicians rate 17 symptom areas covering academic, social, health and cognitive functioning. Administered alone, the CDRS-R takes 15-20 minutes to complete. Administered with the ADIS-IV, it requires an additional 5 minutes with the parent or child because many questions overlap. The majority of ratings also get completed by the Interviewer after the ADIS is completed (not directly with parent or child). | ClinicalTrials.gov |
| Secondary | Change in Strengths and Difficulties Questionnaire total impairment - parent report | Change from pre-treatment to post-treatment (an average of 16 weeks) | a brief 25-item behavioral screening questionnaire assessing 5 domains (emotional symptoms, conduct problems, hyperactivity/inattention, peer relationships problems, and prosocial behaviors). Parents and youth will rate this at pre- and posttreatment. | ClinicalTrials.gov |
| Secondary | Change in Strengths and Difficulties Questionnaire total impairment - child report | Change from pre-treatment to post-treatment (an average of 16 weeks) | a brief 25-item behavioral screening questionnaire assessing 5 domains (emotional symptoms, conduct problems, hyperactivity/inattention, peer relationships problems, and prosocial behaviors). Parents and youth will rate this at pre- and posttreatment. | ClinicalTrials.gov |
| Secondary | Change in State-Trait Anxiety Inventory for Children (STAIC) - Trait Scale: parent | Trajectory of change across weekly sessions (weeks 1 through completion; on average 16 weeks) | The STAIC-Trait scale (Speilberger et al., 1973) is a 20-item scale that assesses global anxiety that remains consistent across situations (trait anxiety). Only youth will complete this measure. Normative and reliability data are available (Spielberger et al., 1973). Factor-analytic studies support the state-trait distinction (Finch, Kendall, \& Montgomery, 1974). | ClinicalTrials.gov |
| Secondary | Change in State-Trait Anxiety Inventory for Children (STAIC) - Trait Scale: child | Trajectory of change across weekly sessions (weeks 1 through completion; on average 16 weeks) | The STAIC-Trait scale (Speilberger et al., 1973) is a 20-item scale that assesses global anxiety that remains consistent across situations (trait anxiety). Only youth will complete this measure. Normative and reliability data are available (Spielberger et al., 1973). Factor-analytic studies support the state-trait distinction (Finch, Kendall, \& Montgomery, 1974). | ClinicalTrials.gov |
| Secondary | Change in Revised Children's Anxiety and Depression Scale (RCADS) - Parent | Change from pre-treatment to post-treatment (an average of 16 weeks) | RCADS-C/P (Chorpita, Yim, Moffitt, Umemoto,\& Francis, 2000) is a 47-item scale whose items correspond closely to DSM-IV anxiety and major depressive disorders. Parallel parent and child versions will be used. Factor analysis has yielded subscales associated with the diagnoses of interest (e.g., Separation Anxiety Disorder, Social Phobia, Generalized Anxiety Disorder, Major Depressive Disorder). The subscales demonstrated good factorial validity, internal consistency, one-week test-retest reliability, and good convergent and discriminant validity (Chorpita et al., 2000). It has also demonstrated reasonable convergent validity with other leading anxiety and depression measures (e.g., Revised Children's Manifest Anxiety Scale, Children's Depression Inventory; Chorpita et al., 2000). The RCADS-Parent Form (RCADS-P) is a 47-item parent-report version of the youth RCADS. | ClinicalTrials.gov |
| Secondary | Change in Revised Children's Anxiety and Depression Scale (RCADS) - depression subscale | Trajectory of change across weekly sessions (weeks 1 through completion; on average 16 weeks) | The depression subscale is the 10-items from the long form that assesses depression symptoms. | ClinicalTrials.gov |
| Secondary | Change in Multidimensional Anxiety Scale for Children - Child | Change from pre-treatment to post-treatment (an average of 16 weeks) | Multidimensional Anxiety Scale for Children - Child and Parent Forms (March, 1997). The MASC includes both a long form (39-items) and a short form (10-items; MASC-10) designed for repeated assessments. Parallel parent and child versions will be used. The long form consists of 39 items, rated on a "0" (Never True) to "3" (Often True about me) scale, distributed across four broad scales (Physical Symptoms, Harm Avoidance, Social Anxiety, Separation/Panic) that also has six subscales. The MASC has been normed on large samples and is one of the most widely used anxiety symptom measures. The 10-item short form (MASC-10) can be administered rapidly (1 min) for repeated testing. | ClinicalTrials.gov |
| Secondary | Change in Multidimensional Anxiety Scale for Children - Parent | Change from pre-treatment to post-treatment (an average of 16 weeks) | Multidimensional Anxiety Scale for Children - Child and Parent Forms (March, 1997). The MASC includes both a long form (39-items) and a short form (10-items; MASC-10) designed for repeated assessments. Parallel parent and child versions will be used. The long form consists of 39 items, rated on a "0" (Never True) to "3" (Often True about me) scale, distributed across four broad scales (Physical Symptoms, Harm Avoidance, Social Anxiety, Separation/Panic) that also has six subscales. The MASC has been normed on large samples and is one of the most widely used anxiety symptom measures. The 10-item short form (MASC-10) can be administered rapidly (1 min) for repeated testing. | ClinicalTrials.gov |
| Secondary | Change in Multidimensional Anxiety Scale for Children - Brief form | Trajectory of change across weekly sessions (weeks 1 through completion; on average 16 weeks) | This is the 10-item brief form of the MASC. | ClinicalTrials.gov |
| Secondary | Change in Center for Epidemiologic Studies-Depression Scale (CES-D) - Child | Change from pre-treatment to post-treatment (an average of 16 weeks) | The CES-D (parent and child forms) includes 20 items designed to assess depressed mood, feelings of worthlessness/guilt, sense of helplessness/hopelessness, psychomotor retardation, loss of appetite, and sleep disturbance. Parallel parent and child versions will be used. Using a four-point scale, respondents indicate the frequency with which symptoms have been experienced during the past week. Response categories include 0 = rarely (less than 1 day); 1 = little (1-2 days); 2 = moderately (3 to 4 days); or 3 = most of the time (5-7 days). Four items are reverse-scored, and a composite is calculated by summing item responses (range 0-60). CES-D was developed with adults but has been applied without adaptation to young adolescents. A cutoff point of 16 and above for screening adolescents for current major depressive disorder or dysthymia is considered optimal. | ClinicalTrials.gov |
| Secondary | Change in Center for Epidemiologic Studies-Depression Scale (CES-D) - Parent | Change from pre-treatment to post-treatment (an average of 16 weeks) | The CES-D (parent and child forms) includes 20 items designed to assess depressed mood, feelings of worthlessness/guilt, sense of helplessness/hopelessness, psychomotor retardation, loss of appetite, and sleep disturbance. Parallel parent and child versions will be used. Using a four-point scale, respondents indicate the frequency with which symptoms have been experienced during the past week. Response categories include 0 = rarely (less than 1 day); 1 = little (1-2 days); 2 = moderately (3 to 4 days); or 3 = most of the time (5-7 days). Four items are reverse-scored, and a composite is calculated by summing item responses (range 0-60). CES-D was developed with adults but has been applied without adaptation to young adolescents. A cutoff point of 16 and above for screening adolescents for current major depressive disorder or dysthymia is considered optimal. | ClinicalTrials.gov |
| Secondary | Change in Adolescent Alcohol and Drug Involvement Scale (AADIS): incidents of substance abuse | Change from pre-treatment to post-treatment (an average of 16 weeks) | For youth 13 years and older, diagnosticians will complete the Adolescent Alcohol and Drug Involvement Scale (AADIS) to screen for alcohol and substance use. All teens will be asked if they have ever used tobacco, alcohol, or marijuana and then interviewers will give a general prompt for other substance use. If the teen endorses use of other elicit or controlled substances, frequency ratings will be obtained. If the teen endorses any substance use, the interviewer will administer an additional 14 items assessing the context, function, and history of drug and alcohol use. The AADIS has been tested to be reliable and appropriate for adolescent respondents (Winters, 2003). | ClinicalTrials.gov |
| Secondary | Change in Olweus Bully/Victim Questionnaire - Parent and Child report (OBVQ-P/C): frequency of victimization events | Change from pre-treatment to post-treatment (an average of 16 weeks) | The OBVQ (Solberg \& Olweus, 2003), designed for grades 3-10, is used to assess experiences with being bullied and bullying others. The OBVQ will be administered as an interview, individually with the child and parent/s, following the other clinician-administered measures (ADIS, AADIS, SACA). A shortened and revised version of the original OBVQ (28 items) will be used that includes global assessment of being bullied and bullying others, as well as specific items that assess nine different forms of bullying including hitting and kicking, spreading false rumors, ignoring peers, and bullying of a sexual or racial nature. The OBVQ demonstrated adequate internal consistency (alpha \> .80), and construct and criterion-related validity have been reported (Solberg \& Olweus, 2003). | ClinicalTrials.gov |
| Secondary | Change in Multidimensional Bullying Impact Scale (MBIS) - total impairment score | Change from pre-treatment to post-treatment (an average of 16 weeks) | The MBIS is a recently developed measure (Chu, B. C., Hoffman, L., Johns, A., Reyes-Portillo, J., \& Hansford, A, 2014) that assesses socio-emotional impairment related to bullying in school-aged youth. The BIS is a 44-item measure, rated 0 (not at all) to 3 (most of the time; total range: 0 - 60). Initial piloting demonstrated that BIS total scores correlated with bullying experiences and anxiety and depressive symptoms (Chu et al., 2014). Items begin with the clause, "When I have been bullied, I..." and assess the frequency that victimization negatively impacts family relations, peer relations, academic performance and attendance, and extracurricular participation. | ClinicalTrials.gov |
| Secondary | Change in Child Behavior Checklist (CBCL) - total internalizing score | Change from pre-treatment to post-treatment (an average of 16 weeks) | The CBCL (Achenbach, 2001) is a 118-item parent-report scale assessing behavioral problems and social competencies. Only parents will complete this measure. Items are rated from not true (0) to very true or often true (2). The CBCL has broadband internalizing and externalizing factors and eight specific scales (e;g., anxiety-depression). Normative data are available. The CBCL has high retest reliability, interparent agreement, and validity. It was highly correlated with similar parent measures of child behavior, and scaled scores and clinical cutpoints discriminated between referred and nonreferred children. | ClinicalTrials.gov |
| Secondary | Change in Child Behavior Checklist (CBCL) - total externalizing score | Change from pre-treatment to post-treatment (an average of 16 weeks) | The CBCL (Achenbach, 2001) is a 118-item parent-report scale assessing behavioral problems and social competencies. Only parents will complete this measure. Items are rated from not true (0) to very true or often true (2). The CBCL has broadband internalizing and externalizing factors and eight specific scales (e;g., anxiety-depression). Normative data are available. The CBCL has high retest reliability, interparent agreement, and validity. It was highly correlated with similar parent measures of child behavior, and scaled scores and clinical cutpoints discriminated between referred and nonreferred children. | ClinicalTrials.gov |
| Secondary | Change in Responses to Stress Questionnaire (RSQ)-Youth | Trajectory of change every four weeks from pretreatment to postreatment (an average of 16 weeks) | The RSQ (Connor-Smith et al., 2000) will be used to assess youth-self-reports and parent-reports of the use of primary control and secondary control coping strategies in response to significant life stressors. Research with three samples of adolescents and two samples of parents (reporting on their adolescents) has shown good evidence for the psychometric integrity of the measure. The factor structure of the RSQ has been tested and replicated using confirmatory factor analysis across three stressor classes in two samples. And both internal consistency and retest reliability of the five factors are strong, across samples. Across samples, scores on the primary and secondary control coping factors have shown strong negative correlations with both internalizing and externalizing problems. The parent form consists of 68 items and can be administered to target anxiety (RSQP-Scared) or depressive feelings (RSQP-Bad). The child form (Responses to Stress) is a shorter 30-item scale. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 10
The papers the trial lists on ClinicalTrials.gov.
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 2
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Emotional Stroop Task | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)