Transdiagnostic Individual Behavioral Activation and Exposure Therapy

NCT03412227 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2023-11-18

No results posted yet for this study

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

Interventions

BEHAVIORAL

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.

BEHAVIORAL

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).

BEHAVIORAL

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.

OTHER

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).

Sponsors & Collaborators

  • Rutgers University

    lead OTHER

Principal Investigators

  • Brian C Chu, Ph.D. · Rutgers University (Youth Anxiety and Depression Clinic)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
9 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-01
Primary Completion
2024-08-31
Completion
2025-08-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03412227 on ClinicalTrials.gov