Recruiting

IBAT vs. Coping Cat, PASCET

Sponsor:

Rutgers University

Code:

NCT03412227

Conditions

Anxiety Disorders

Depression

Eligibility Criteria

Sex: All

Age: 9 - 17

Healthy Volunteers: Not accepted

Interventions

Individual Behavioral Activation Therapy (IBAT)

The PASCET Program for Youth Depressive Disorders

The Coping Cat Program for Youth Anxiety Disorders

14-week waitlist (WL) condition

Study Details

Brief summary:

The Overall Aim of the this project is to compare treatment outcomes and change in putative treatment mediators in Individual Behavioral Activation Therapy (IBAT) against two active psychological interventions (Coping Cat, PASCET) and a wait-list control. Participants will be 200 youth (ages 9-17) diagnosed with a principal anxiety or depression disorder and their caregivers.

Conditions

Anxiety Disorders

Depression

Study ID

NCT03412227

Start date

Feb 1, 2018

Status verified date

Nov, 2023

Completion date

Aug 31, 2025

Anticipated

Primary completion date

Aug 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 9 - 17

Healthy Volunteers: Not accepted

We expect 200 youth (ages 9-17 years) with either a principle anxiety (n=100) or a unipolar depression disorder (n=100) and their parents/caregivers to serve as participants.

Inclusion Criteria:

To participate, a youth must meet criteria for a primary DSM-5 (American Psychiatric Association, 2003) diagnosis of any of the following:

  • Generalized Anxiety Disorder (GAD)
  • Separation Anxiety Disorder (SEP)
  • Social Anxiety Disorder (SAD)
  • Specific Phobia (SP)
  • Panic Disorder (PD)
  • Agoraphobia
  • Major Depression Disorder (MDD)
  • Depression Disorder - Insufficient Symptoms (DD-Insufficient)
  • Persistent Depressive Disorder (PDD)

Comorbid (non-principal) disorders are acceptable, including the presence of disorders not listed above. Diagnosis will be based on both youth and parent report during an Independent Evaluator (IE) semi-structured interview. Youth may also participate with a subclinical diagnosis for any of these disorders if: (a) the youth demonstrates sufficient symptoms but does not yet reach clinical levels of impairment OR (b) the youth demonstrates only several symptoms related to the above disorders but demonstrates clinical impairment, AND (c) the consenting parent agrees that anxiety or mood problems would be appropriate as a clinical focus for treatment. Allowing youth with subclinical diagnoses will allow the study to investigate the effectiveness of the therapies across a range of clinical severity. This design models usual community care where a larger range of severity is witnessed and many youth may not meet all criteria for formal diagnosis. After receiving an initial diagnostic assessment at T1, the parent must consent and the youth must assent to continued participation in the study, including randomization to treatment condition, and must be willing to receive psychological therapy at the Youth Anxiety and Depression Clinic (YAD-C), a specialty program within the outpatient clinic of the Rutgers University Graduate School of Applied and Professional Psychology (GSAPP).

Exclusion Criteria:

Youth who have a principal DSM-5 disorder other than one of the above listed anxiety or depression disorders (e.g., anorexia nervosa, Post-traumatic Stress Disorder, Attention Deficit-Hyperactivity Disorder), or who have received any diagnosis of:

  • Intellectual Disability
  • Autism Spectrum Disorder
  • schizophrenia
  • bipolar disorder.

Youth who demonstrate suicidal ideation or intent (by child or parent report) severe enough to require current hospitalization, or youth who have attempted suicide in the past 3 months, will also be excluded. These clinical problems require specialized treatment that YAD-C is not prepared to offer. Youth will not be excluded on the basis of gender or racial/ethnic origin. However, youth and at least one parent will be required to speak English sufficiently enough to complete study procedures and surveys in English. Participants will be asked not to engage in any other outpatient psychological treatment during their time in the study; this is important to enhance internal validity of the study and conforms with best clinical practices to avoid conflicting treatment recommendations. However, current use of antidepressant or anxiolytic medications will NOT be an exclusion. Participants will be asked to arrive at a stable dosage and schedule for their medication, in consultation with their presiding physician or psychiatrist, prior to study initiation. Use of medications and any other treatment modalities will be assessed during study participation and compared across treatment and WL conditions.

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Principal Anxiety Disorder

Youth with a principal anxiety disorder

other: Principal Depressive Disorder

Youth with a principal unipolar depressive disorder

Interventions

Individual Behavioral Activation Therapy (IBAT)

IBAT is a manual-based, individual behavioral activation plus exposure therapy aimed at treating youth with anxiety, depression, and anger. The program consists of 10-14 weekly 60 minute sessions. It uses behavioral activation (BA) strategies to target avoidance by helping youth identify stuck points in their lives through functional assessment of numerous life domains, including family and peer interactions, school, extracurricular activities, and health and self-care.

The PASCET Program for Youth Depressive Disorders

The Primary and Secondary Control Enhancement Therapy (PASCET; Weisz, Southam-Gerow, Gordis, \& Connor-Smith, 2003; Weisz, Southam-Gerow et al., 2009; Weisz, Thurber, Sweeney, Proffitt, \& LeGagnoux, 1997) is a brief (usually 11-15 sessions) CBT program for depressed youths typically aged 8-15. Sessions and practice assignments are built on findings concerning cognitive and behavioral features of, and beneficial treatments for, youth depression (e.g., Lewinsohn et al., 1990; Stark et al., 1987), and on the two-process model of perceived control and coping (Rothbaum, Weisz, \& Snyder, 1982; Weisz et al., 1984a,b).

The Coping Cat Program for Youth Anxiety Disorders

The "Coping Cat" program (Kendall \& Hedtke, 2006; Kendall, Choudhury, Hudson, \& Webb, 2002) has received substantial empirical support for its efficacy in both children (9-13 years old) and teens (12 - 17 years old) (Kendall, 1994; Kendall et al., 1997; Kendall et al., 2008) and involves (1) teaching children to identify their own anxious feelings and physiological signs of anxiety, (2) teaching children to identify their own anxiety-provoking cognitions, (3) developing a plan to guide coping - a plan that involves changing the child's thoughts (into positive self-talk) and actions (into self-initiated exposures), and (4) self-evaluation and self-reward.

14-week waitlist (WL) condition

Youth assigned to the 14-week WL will receive no specific therapeutic services from study therapists during the 14-week WL period. However, participants will be assigned a WL Liaison whom families can contact in the event of clinical deterioration. The Liaison will also be responsible for sending links to, and monitor completion of, weekly and mid-WL online surveys (Qualtrics). Independent Evaluators will conduct post-WL diagnostic interviews at the completion of the 14-week WL. WL participants will receive compensation for completion of assessments. After completion of the WL, participants will be invited to continue in the study and be randomly assigned to one of the three behavioral treatments (IBAT, PASCET, or Coping Cat).

Primary outcome measure

  • Change in Clinical Global Impression Severity (CGIS) Scale: Independent Evaluator [ Time Frame: Change from pre-treatment to post-treatment (baseline to 14-weeks) ]

Central Contacts and Locations

Central contacts

Locations

Youth Anxiety and Depression Clinic

Recruiting

Piscataway, New Jersey, United States, 08854

Contacts

More Information

Sponsor

Rutgers University

Last update posted

Nov 18, 2023

Last verified

Nov, 2023

Keywords

  • Anxiety
  • Depression
  • Children
  • Adolescents
  • CBT

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rutgers University on 2023-11-18.