Anxiety DisordersNCT03412227
Transdiagnostic Individual Behavioral Activation and Exposure Therapy
A study testing Individual Behavioral Activation Therapy (IBAT), The PASCET Program for Youth Depressive Disorders and The Coping Cat Program for Youth Anxiety Disorders in people with Anxiety Disorders and Depression, run by Rutgers University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 17 years
- Conditions the study is for
- Anxiety Disorders, Depression
- What is being tested?
- Individual Behavioral Activation Therapy (IBAT), The PASCET Program for Youth Depressive Disorders and The Coping Cat Program for Youth Anxiety Disorders
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2018to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Show all 11Show fewer
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Youth Anxiety and Depression Clinic
Piscataway, New Jersey, 08854
Brian Chu, PhD, 848-445-3905, yadc@gsapp.rutgers.edu
About this study
Official title: Randomized Clinical Trial of Transdiagnostic Behavioral Activation and Exposure Therapy for Youth: A Comparison of Effects and Mediators
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.
Read the detailed description
Anxiety and unipolar depression are highly debilitating and commonly co-occurring in young adolescents with lifetime prevalence rates estimated at 8.4% for major depression or dysthymia and at 31.4% for any anxiety disorder in youth ages 13-14 (Merikangas et al., 2010). Cognitive and behavioral therapies (CBT) have received strong support for reducing distress in youth (Silverman, Pina, \& Viswesvaran, 2008; David-Ferdon \& Kaslow, 2008), but efficacy rates peak around 50-70% for anxiety and less for depression. Evidence is accumulating that "transdiagnostic" behavioral therapies that address multiple problems at the same time can enhance treatment outcomes by targeting the mechanisms that underlie commonly co-occurring problems, like anxiety and depression (Chu, Temkin, \& Toffey, 2016; Temkin, Yadegar, Laurine, \& Chu, in press). Furthermore, consolidated transdiagnostic treatment protocols can provide the same level of clinical benefit while delivering active components in a more efficient package, which can increase treatment efficiency and potentially make it easier to train novice clinicians in the future (Chu, 2012; Ehrenreich \& Chu, 2013). While the evidence-base is growing for adult conditions, transdiagnostic interventions have been examined less in child and adolescent populations. Our team has demonstrated the efficacy of a school-based group transdiagnostic intervention that made use of behavioral activation (BA) and exposure therapy to address anxiety and depression for middle-school youth (Chu, Crocco, Esseling, Areizaga, Lindner, \& Skriner, 2016). BA refers to a set of interventions that teach youth how to assess which stressors trigger avoidant coping responses in their lives (i.e., functional assessment) and learn how to address problems with pro-active problem solving strategies. Exposure therapy refers to a set of behavioral interventions that foster new learning tendencies by encouraging and reinforcing contact with the situations that scare individuals. Both sets of strategies have received substantial support in treating youth anxiety and depression. The Chu et al., (2016) trial demonstrated that these two treatment components could be combined and effectively treat a sample of youth reporting either anxiety or depression.
The Chu et al. (2016) study was novel because most forms of evidence-based treatment have been designed as "single disorder" protocols, such that the interventions were designed to target one clinical problem at a time. The current trial takes the following innovative steps. The study will: (a) adapt the Chu et al. group-based protocol to an individual format, (b) deliver the program in a clinical outpatient setting, and (c) utilize three comparison conditions, including a wait-list control and two active psychological interventions. The two active interventions will be single disorder cognitive behavioral therapies (CBT) that were designed to specifically address either youth depression (Primary and Secondary Control Enhancement Therapy; PASCET; Weisz, Thurber, Sweeney, Proffitt, \& LeGagnoux, 1997) or youth anxiety (Coping Cat; Kendall, 1994; Kendall et al., 1997). Both have received substantial support in the literature for supporting clinical improvements in brief individual formats (12 - 16 weeks). By comparing Individual Behavioral Activation Therapy (IBAT) to each of these active interventions, the study aims to demonstrate (a) superior treatment outcomes to wait-list control, (b) comparable treatment outcomes to PASCET and Coping Cat, and (c) differential mediator effects across the four conditions. Findings will provide support for the feasibility, acceptability, and efficacy of IBAT and provide conceptual support for its purported mediators of change.
The current study is a Randomized Controlled Trial (RCT), comparing a novel behavioral intervention (Individual Behavioral Activation Therapy, IBAT) against two established cognitive-behavioral interventions (Coping Cat, PASCET) and a 14-week waitlist (WL) control. Participants will be 160 youth (ages 9-16 years old) who receive a diagnosis of a Diagnostic and Statistical Manual - 5th edition (DSM-5; APA, 2013) anxiety or depression disorder and their caregivers. Participants will be randomly assigned evenly to each of four conditions. The study intends to recruit participants within a 2.5-year period and complete all active participant participation within 3 years.
Specific aims include the following:
Aim 1 - Treatment Efficacy: To evaluate differences in treatment outcomes across IBAT, PASCET, CC, and WL conditions across pre-, mid-, and post-treatment in treatment efficacy, focusing on key diagnostic and symptom outcomes (i.e., CGI, principal diagnosis presence to absence and clinical severity, RCADS anxiety and depression scores, MASC, CESD).
Hypothesis 1: IBAT will produce superior outcomes to 14-week WL control
Hypothesis 2: The three active treatment conditions (IBAT, PASCET, CC) will demonstrate superior treatment outcomes to 14-week WL control, but will not be different from each other.
Aim 2 - Mediator Analysis: To examine the strength of putative mediators in explaining the effects of active treatments (IBAT, CC, PASCET) in comparison to the 14-week WL and in comparison to each other. Putative mediators will include multiple domains: (a) youth socio-emotional functioning (cognitive, behavioral, and affective responses), (b) distress tolerance as assessed by computer tasks, (c) family environment and interactions, (d) caregiver distress and functioning, (e) client and therapist perception of psychotherapy process, (f) ecological momentary assessment and passive sensor data.
Hypothesis 3: Each domain will prove to provide significant mediators for each treatment in comparison to the WL control.
Hypothesis 4: Cognitive mediators will prove to provide significant mediation of CC and PASCET treatment effects, but not necessarily for IBAT.
Hypothesis 5: Distress tolerance will prove to provide significant mediator for IBAT treatment effects, but not necessarily for CC or PASCET.
Aim 3. Note patterns of additional youth mental health services and auxiliary services that families seek beyond treatment received at the Youth Anxiety and Depression Clinic.
- Conditions
- Anxiety Disorders, Depression
- Being tested
- 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
- Keywords
- Anxiety, Depression, Children, Adolescents, CBT
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individual Behavioral Activation Therapy (IBAT)Behavioural
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 DisordersBehavioural
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 DisordersBehavioural
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) conditionOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Principal Anxiety Disorder | Other | Youth with a principal anxiety disorder Receives: Behavioral: Individual Behavioral Activation Therapy (IBAT); Behavioral: The Coping Cat Program for Youth Anxiety Disorders; Other: 14-week waitlist (WL) condition |
| Principal Depressive Disorder | Other | Youth with a principal unipolar depressive disorder Receives: Behavioral: Individual Behavioral Activation Therapy (IBAT); Behavioral: The PASCET Program for Youth Depressive Disorders; Other: 14-week waitlist (WL) condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Clinical Global Impression Severity (CGIS) Scale: Independent Evaluator
The CGI-S score provides a global rating of baseline severity ranging from 1 (not at all ill) to 7 (extremely ill), while the CGI-I provides a global rating of clinical improvement ranging from 1 (Very Much Improved) to 7 (Very Much Worse). The IE will provide a baseline CGI ratings for each patient at pretreatment and posttreatment. Subjects receiving a CGI-I rating of 1 (Very Much Improved) or 2 (Much Improved) by the IE at the end of posttreatment will be considered responders of treatment.
Measured: Change from pre-treatment to post-treatment (baseline to 14-weeks)
Secondary outcomes (2)
Change in Behavioral Activation
The BADS-Y is a 26-item adaptation of the adult BADS (Kanter et al., 1997; Kanter et al., 1999), rated on a "0" (Not at All) to "6" (Completely) scale, designed to assess level of behavioral activation and avoidance. Factor analysis in the adult version detected four factors: Activation, Avoidance/Rumination, Work/School Impairment, and Social Impairment) with good factor structure, internal consistency and test-retest reliability. Normative data was also collected in an adult community sample. BADS-A was adapted for the current study to reflect developmentally appropriate reading level and concepts.
Measured: Change from pre-treatment to post-treatment (baseline to 14-weeks)
Child Automatic Thoughts Scale-Negative/Positive
The CATS is a 50-item child-report measure designed to assess negative and positive self-statements in children and adolescents. The CATS was developed and validated on a wide age range of youth (7 - 16 years old) and found to effectively discriminate between non-clinical youth and those with clinical anxiety, depression, and behavior disorders. Confirmatory factor analyses supported four distinct but strongly correlated factors relating to automatic thoughts on physical threat, social threat, personal failure and hostility. The internal consistency of the total score and subscales was high (α > .85) and test-retest reliability at 1 and 3 months was acceptable (r = .91).
Measured: Change from pre-treatment to post-treatment (baseline to 14-weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2018
- Study start1 Feb 2018
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (103)Papers the sponsor has linked to this study.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Clinical Trial, stratified by principal youth diagnosis (anxiety or depression).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian C. Chu, Rutgers University
- Investigators
- Brian C Chu, Ph.D., Principal investigator, Rutgers University (Youth Anxiety and Depression Clinic)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03412227
- Sponsor's protocol ID
- Pro20170001171
- Status last verified
- Nov 2023
- First submitted
- 15 Oct 2017
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
GenIUSS (2014). Best practices for asking questions to identify transgender and other gender minority respondents on population-based surveys. Retrieved from https://williamsinstitute.law.ucla.edu/wp-content/uploads/geniuss-report-sep-2014.pdf
Fenway Institute (n.d.). Asking patients questions about sexual orientation and gender identity in clinical settings: A study in four health centers. Retrieved from http://thefenwayinstitute.org/wp-content/uploads/COM228_SOGI_CHARN_WhitePaper.pdf
Official New York City Website (n.d.). Respectfully asking sexual orientation and gender identity (SOGI) questions. Retrieved from https://www1.nyc.gov/assets/acs/pdf/lgbtq/Respectfully_Asking_SOGI_Questions.pdf
Achenbach, T. M. (2001). Manual for the ASEBA Child Behavior Checklist for Ages 6-18. Burlington, VT: Achenbach System of Empirically Based Assessment.
American Psychiatric Association (2000). Diagnostic and Statistical Manual of Mental Disorders-IV-TR (4th Ed., Text Revision). Arlington, VA: American Psychiatric Association.
American Psychiatric Association (2013). Diagnostic and Statistical Manual of Mental Disorders-IV-TR (5th Ed.). Arlington, VA: American Psychiatric Association.
Ashrafioun L, Dambra CM, Blondell RD. Parental prescription opioid abuse and the impact on children. Am J Drug Alcohol Abuse. 2011 Nov;37(6):532-6. doi: 10.3109/00952990.2011.600387. Epub 2011 Aug 18.
PubMed 21851201Barlow, D. H. & Hersen, M. (1984). Single-case experimental designs: Strategies for studying behavior change (2nd Ed.). New York: Pergamon Press.
Barrett PM, Rapee RM, Dadds MM, Ryan SM. Family enhancement of cognitive style in anxious and aggressive children. J Abnorm Child Psychol. 1996 Apr;24(2):187-203. doi: 10.1007/BF01441484.
PubMed 8743244Bornovalova MA, Gratz KL, Daughters SB, Nick B, Delany-Brumsey A, Lynch TR, Kosson D, Lejuez CW. A multimodal assessment of the relationship between emotion dysregulation and borderline personality disorder among inner-city substance users in residential treatment. J Psychiatr Res. 2008 Jul;42(9):717-26. doi: 10.1016/j.jpsychires.2007.07.014. Epub 2007 Sep 14.
PubMed 17868698Brandon TH, Herzog TA, Juliano LM, Irvin JE, Lazev AB, Simmons VN. Pretreatment task persistence predicts smoking cessation outcome. J Abnorm Psychol. 2003 Aug;112(3):448-56. doi: 10.1037/0021-843x.112.3.448.
PubMed 12943023Carey MP, Faulstich ME, Carey TC. Assessment of anxiety in adolescents: concurrent and factorial validities of the Trait Anxiety scale of Spielberger's State-Trait Anxiety Inventory for Children. Psychol Rep. 1994 Aug;75(1 Pt 1):331-8.
PubMed 7984747Chorpita BF, Weisz JR, Daleiden EL, Schoenwald SK, Palinkas LA, Miranda J, Higa-McMillan CK, Nakamura BJ, Austin AA, Borntrager CF, Ward A, Wells KC, Gibbons RD; Research Network on Youth Mental Health. Long-term outcomes for the Child STEPs randomized effectiveness trial: a comparison of modular and standard treatment designs with usual care. J Consult Clin Psychol. 2013 Dec;81(6):999-1009. doi: 10.1037/a0034200. Epub 2013 Aug 26.
PubMed 23978169Chorpita BF, Yim L, Moffitt C, Umemoto LA, Francis SE. Assessment of symptoms of DSM-IV anxiety and depression in children: a revised child anxiety and depression scale. Behav Res Ther. 2000 Aug;38(8):835-55. doi: 10.1016/s0005-7967(99)00130-8.
PubMed 10937431Chu BC, Kendall PC. Therapist responsiveness to child engagement: flexibility within manual-based CBT for anxious youth. J Clin Psychol. 2009 Jul;65(7):736-54. doi: 10.1002/jclp.20582.
PubMed 19391153
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of Transdiagnostic Behavioral Activation and Exposure Therapy for Youth: A Comparison of Effects and Mediators
- ClinicalTrials.gov ID
- NCT03412227
- Acronym / sponsor ID
- Pro20170001171
- Conditions
- Anxiety Disorders, Depression
- Keywords
- Anxiety, Depression, Children, Adolescents, CBT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Rutgers UniversityUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 26 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Anxiety and unipolar depression are highly debilitating and commonly co-occurring in young adolescents with lifetime prevalence rates estimated at 8.4% for major depression or dysthymia and at 31.4% for any anxiety disorder in youth ages 13-14 (Merikangas et al., 2010). Cognitive and behavioral therapies (CBT) have received strong support for reducing distress in youth (Silverman, Pina, \& Viswesvaran, 2008; David-Ferdon \& Kaslow, 2008), but efficacy rates peak around 50-70% for anxiety and less for depression. Evidence is accumulating that "transdiagnostic" behavioral therapies that address multiple problems at the same time can enhance treatment outcomes by targeting the mechanisms that underlie commonly co-occurring problems, like anxiety and depression (Chu, Temkin, \& Toffey, 2016; Temkin, Yadegar, Laurine, \& Chu, in press). Furthermore, consolidated transdiagnostic treatment protocols can provide the same level of clinical benefit while delivering active components in a more efficient package, which can increase treatment efficiency and potentially make it easier to train novice clinicians in the future (Chu, 2012; Ehrenreich \& Chu, 2013). While the evidence-base is growing for adult conditions, transdiagnostic interventions have been examined less in child and adolescent populations. Our team has demonstrated the efficacy of a school-based group transdiagnostic intervention that made use of behavioral activation (BA) and exposure therapy to address anxiety and depression for middle-school youth (Chu, Crocco, Esseling, Areizaga, Lindner, \& Skriner, 2016). BA refers to a set of interventions that teach youth how to assess which stressors trigger avoidant coping responses in their lives (i.e., functional assessment) and learn how to address problems with pro-active problem solving strategies. Exposure therapy refers to a set of behavioral interventions that foster new learning tendencies by encouraging and reinforcing contact with the situations that scare individuals. Both sets of strategies have received substantial support in treating youth anxiety and depression. The Chu et al., (2016) trial demonstrated that these two treatment components could be combined and effectively treat a sample of youth reporting either anxiety or depression.
The Chu et al. (2016) study was novel because most forms of evidence-based treatment have been designed as "single disorder" protocols, such that the interventions were designed to target one clinical problem at a time. The current trial takes the following innovative steps. The study will: (a) adapt the Chu et al. group-based protocol to an individual format, (b) deliver the program in a clinical outpatient setting, and (c) utilize three comparison conditions, including a wait-list control and two active psychological interventions. The two active interventions will be single disorder cognitive behavioral therapies (CBT) that were designed to specifically address either youth depression (Primary and Secondary Control Enhancement Therapy; PASCET; Weisz, Thurber, Sweeney, Proffitt, \& LeGagnoux, 1997) or youth anxiety (Coping Cat; Kendall, 1994; Kendall et al., 1997). Both have received substantial support in the literature for supporting clinical improvements in brief individual formats (12 - 16 weeks). By comparing Individual Behavioral Activation Therapy (IBAT) to each of these active interventions, the study aims to demonstrate (a) superior treatment outcomes to wait-list control, (b) comparable treatment outcomes to PASCET and Coping Cat, and (c) differential mediator effects across the four conditions. Findings will provide support for the feasibility, acceptability, and efficacy of IBAT and provide conceptual support for its purported mediators of change.
The current study is a Randomized Controlled Trial (RCT), comparing a novel behavioral intervention (Individual Behavioral Activation Therapy, IBAT) against two established cognitive-behavioral interventions (Coping Cat, PASCET) and a 14-week waitlist (WL) control. Participants will be 160 youth (ages 9-16 years old) who receive a diagnosis of a Diagnostic and Statistical Manual - 5th edition (DSM-5; APA, 2013) anxiety or depression disorder and their caregivers. Participants will be randomly assigned evenly to each of four conditions. The study intends to recruit participants within a 2.5-year period and complete all active participant participation within 3 years.
Specific aims include the following:
Aim 1 - Treatment Efficacy: To evaluate differences in treatment outcomes across IBAT, PASCET, CC, and WL conditions across pre-, mid-, and post-treatment in treatment efficacy, focusing on key diagnostic and symptom outcomes (i.e., CGI, principal diagnosis presence to absence and clinical severity, RCADS anxiety and depression scores, MASC, CESD).
Hypothesis 1: IBAT will produce superior outcomes to 14-week WL control
Hypothesis 2: The three active treatment conditions (IBAT, PASCET, CC) will demonstrate superior treatment outcomes to 14-week WL control, but will not be different from each other.
Aim 2 - Mediator Analysis: To examine the strength of putative mediators in explaining the effects of active treatments (IBAT, CC, PASCET) in comparison to the 14-week WL and in comparison to each other. Putative mediators will include multiple domains: (a) youth socio-emotional functioning (cognitive, behavioral, and affective responses), (b) distress tolerance as assessed by computer tasks, (c) family environment and interactions, (d) caregiver distress and functioning, (e) client and therapist perception of psychotherapy process, (f) ecological momentary assessment and passive sensor data.
Hypothesis 3: Each domain will prove to provide significant mediators for each treatment in comparison to the WL control.
Hypothesis 4: Cognitive mediators will prove to provide significant mediation of CC and PASCET treatment effects, but not necessarily for IBAT.
Hypothesis 5: Distress tolerance will prove to provide significant mediator for IBAT treatment effects, but not necessarily for CC or PASCET.
Aim 3. Note patterns of additional youth mental health services and auxiliary services that families seek beyond treatment received at the Youth Anxiety and Depression Clinic.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Clinical Trial, stratified by principal youth diagnosis (anxiety or depression).
| Arm | Type | Receives |
|---|---|---|
| Principal Anxiety Disorder | Other | Behavioral: Individual Behavioral Activation Therapy (IBAT), Behavioral: The Coping Cat Program for Youth Anxiety Disorders, Other: 14-week waitlist (WL) conditionYouth with a principal anxiety disorder |
| Principal Depressive Disorder | Other | Behavioral: Individual Behavioral Activation Therapy (IBAT), Behavioral: The PASCET Program for Youth Depressive Disorders, Other: 14-week waitlist (WL) conditionYouth with a principal unipolar depressive disorder |
Who may qualify
- Ages
- 9 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- 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)
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Principal Anxiety Disorder, Principal Depressive Disorder |
| The PASCET Program for Youth Depressive DisordersThe 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). | Behavioural | Principal Depressive Disorder |
| The Coping Cat Program for Youth Anxiety DisordersThe "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. | Behavioural | Principal Anxiety Disorder |
| 14-week waitlist (WL) conditionYouth 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). | Other | Principal Anxiety Disorder, Principal Depressive Disorder |
Primary outcome
Change in Clinical Global Impression Severity (CGIS) Scale: Independent Evaluator
Time frame: Change from pre-treatment to post-treatment (baseline to 14-weeks)
The CGI-S score provides a global rating of baseline severity ranging from 1 (not at all ill) to 7 (extremely ill), while the CGI-I provides a global rating of clinical improvement ranging from 1 (Very Much Improved) to 7 (Very Much Worse). The IE will provide a baseline CGI ratings for each patient at pretreatment and posttreatment. Subjects receiving a CGI-I rating of 1 (Very Much Improved) or 2 (Much Improved) by the IE at the end of posttreatment will be considered responders of treatment.
2 secondary outcomes
Change in Behavioral Activation
Time frame: Change from pre-treatment to post-treatment (baseline to 14-weeks)
Child Automatic Thoughts Scale-Negative/Positive
Time frame: Change from pre-treatment to post-treatment (baseline to 14-weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- BackgroundGenIUSS (2014). Best practices for asking questions to identify transgender and other gender minority respondents on population-based surveys. Retrieved from https://williamsinstitute.law.ucla.edu/wp-content/uploads/geniuss-report-sep-2014.pdf
- BackgroundFenway Institute (n.d.). Asking patients questions about sexual orientation and gender identity in clinical settings: A study in four health centers. Retrieved from http://thefenwayinstitute.org/wp-content/uploads/COM228_SOGI_CHARN_WhitePaper.pdf
- BackgroundOfficial New York City Website (n.d.). Respectfully asking sexual orientation and gender identity (SOGI) questions. Retrieved from https://www1.nyc.gov/assets/acs/pdf/lgbtq/Respectfully_Asking_SOGI_Questions.pdf
- BackgroundAchenbach, T. M. (2001). Manual for the ASEBA Child Behavior Checklist for Ages 6-18. Burlington, VT: Achenbach System of Empirically Based Assessment.
- BackgroundAmerican Psychiatric Association (2000). Diagnostic and Statistical Manual of Mental Disorders-IV-TR (4th Ed., Text Revision). Arlington, VA: American Psychiatric Association.
- BackgroundAmerican Psychiatric Association (2013). Diagnostic and Statistical Manual of Mental Disorders-IV-TR (5th Ed.). Arlington, VA: American Psychiatric Association.
- Background: PubMed 21851201Ashrafioun L, Dambra CM, Blondell RD. Parental prescription opioid abuse and the impact on children. Am J Drug Alcohol Abuse. 2011 Nov;37(6):532-6. doi: 10.3109/00952990.2011.600387. Epub 2011 Aug 18.
- BackgroundBarlow, D. H. & Hersen, M. (1984). Single-case experimental designs: Strategies for studying behavior change (2nd Ed.). New York: Pergamon Press.
- Background: PubMed 8743244Barrett PM, Rapee RM, Dadds MM, Ryan SM. Family enhancement of cognitive style in anxious and aggressive children. J Abnorm Child Psychol. 1996 Apr;24(2):187-203. doi: 10.1007/BF01441484.
- Background: PubMed 17868698Bornovalova MA, Gratz KL, Daughters SB, Nick B, Delany-Brumsey A, Lynch TR, Kosson D, Lejuez CW. A multimodal assessment of the relationship between emotion dysregulation and borderline personality disorder among inner-city substance users in residential treatment. J Psychiatr Res. 2008 Jul;42(9):717-26. doi: 10.1016/j.jpsychires.2007.07.014. Epub 2007 Sep 14.
- Background: PubMed 12943023Brandon TH, Herzog TA, Juliano LM, Irvin JE, Lazev AB, Simmons VN. Pretreatment task persistence predicts smoking cessation outcome. J Abnorm Psychol. 2003 Aug;112(3):448-56. doi: 10.1037/0021-843x.112.3.448.
- Background: PubMed 7984747Carey MP, Faulstich ME, Carey TC. Assessment of anxiety in adolescents: concurrent and factorial validities of the Trait Anxiety scale of Spielberger's State-Trait Anxiety Inventory for Children. Psychol Rep. 1994 Aug;75(1 Pt 1):331-8.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian C Chu, Ph.D. principal investigator
Rutgers University (Youth Anxiety and Depression Clinic)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individual Behavioral Activation Therapy (IBAT), The PASCET Program for Youth Depressive Disorders and The Coping Cat Program for Youth Anxiety Disorders in people with Anxiety Disorders and Depression, run by Rutgers University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Brian C Chu, Ph.D. (848-445-3905, yadc@gsapp.rutgers.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03412227, which also lists 103 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.