NCT00774150

Brief Summary

The purpose of this study is to investigate neurobehavioral, affective, and social processes that may influence and predict treatment response in pediatric anxiety disorders.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
194

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

October 16, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 17, 2008

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

July 18, 2014

Status Verified

July 1, 2014

Enrollment Period

5.8 years

First QC Date

October 16, 2008

Last Update Submit

July 17, 2014

Conditions

Generalized Anxiety DisorderSeparation Anxiety DisorderSocial Phobia

Keywords

Neural correlates of pediatric anxiety disorderSocial correlates of pediatric anxiety disorderGeneralized Anxiety Disorder in pediatric populationsSeparation Anxiety Disorder in pediatric populationsSocial Phobia in pediatric populations

Outcome Measures

Primary Outcomes (1)

  • Evidence of therapy effects on anxiety symptoms are established by assessments of clinical status, symptoms, affective style, sleep,parent-child interactions using rating scales, self-report measures, and behavioral observations.

    16 weeks

Secondary Outcomes (1)

  • Cognitive and affective information processing will be measured using fMRI, pupil dilation/eye tracking, and event-related potential (ERP) assessment.

    16 weeks

Study Arms (2)

1. Cognitive Behavioral Therapy

EXPERIMENTAL
Behavioral: Cognitive Behavioral Therapy

2. Client Centered Therapy

ACTIVE COMPARATOR
Behavioral: Client Centered Therapy

Interventions

Cognitive Behavioral TherapyBEHAVIORAL

16 sessions of CBT

1. Cognitive Behavioral Therapy
Client Centered TherapyBEHAVIORAL

16 sessions of CCT

2. Client Centered Therapy

Eligibility Criteria

Age9 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Clinical diagnosis of DSM-IV diagnosis of Generalized Anxiety Disorder (GAD), Separation Anxiety Disorder (SAD), and Social Phobia (SP)

You may not qualify if:

  • \. IQ below 70 as assessed by the Wechsler Abbreviated Scale of Intelligence (WASI).
  • \. Requires current ongoing treatment with psychoactive medications including anxiolytics and antidepressants.
  • \. History of head injury. 7. Neuromuscular or neurological disorder 8. Vision that is 20/40 and below that cannot be corrected by glasses or contacts.
  • Current comorbid diagnosis of: primary major depressive disorder (MDD) (subjects who have primary GAD with co-morbid MDD that is secondary in terms of course and functional impact are not excluded), obsessive-compulsive disorder (OCD), post-traumatic stress disorder (PTSD), conduct disorder, substance abuse or dependence
  • Lifetime diagnosis of autism or Asperger syndrome, bipolar disorder, psychotic depression, schizophrenia, or schizoaffective disorder.
  • Any current or lifetime DSM-IV diagnosis.
  • Having a parent with current or lifetime DSM-IV diagnosis of anxiety or mood disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (5)

  • Westbrook CA, Schlund M, Silk JS, Forbes EE, Ryan ND, Dahl RE, McMakin DL, Kendall PC, Mannarino A, Ladouceur CD. The role of reward-related brain activity in response to treatment and later depression severity: data from a randomized controlled trial in early adolescents with anxiety disorders. Transl Psychiatry. 2025 Aug 16;15(1):286. doi: 10.1038/s41398-025-03388-2.

    PMID: 40818984DERIVED

  • Tan PZ, Bylsma LM, Silk JS, Siegle GJ, Forbes EE, McMakin DL, Dahl RE, Ryan ND, Ladouceur CD. Neural indices of performance monitoring are associated with daily emotional functioning in youth with anxiety disorders: An ERP and EMA study. Int J Psychophysiol. 2022 Aug;178:34-42. doi: 10.1016/j.ijpsycho.2022.06.004. Epub 2022 Jun 6.

    PMID: 35679962DERIVED

  • Sequeira SL, Silk JS, Ladouceur CD, Hanson JL, Ryan ND, Morgan JK, McMakin DL, Kendall PC, Dahl RE, Forbes EE. Association of Neural Reward Circuitry Function With Response to Psychotherapy in Youths With Anxiety Disorders. Am J Psychiatry. 2021 Apr 1;178(4):343-351. doi: 10.1176/appi.ajp.2020.20010094. Epub 2021 Jan 21.

    PMID: 33472390DERIVED

  • Ladouceur CD, Tan PZ, Sharma V, Bylsma LM, Silk JS, Siegle GJ, Forbes EE, McMakin DL, Dahl RE, Kendall PC, Mannarino A, Ryan ND. Error-related brain activity in pediatric anxiety disorders remains elevated following individual therapy: a randomized clinical trial. J Child Psychol Psychiatry. 2018 Nov;59(11):1152-1161. doi: 10.1111/jcpp.12900. Epub 2018 Mar 30.

    PMID: 29603219DERIVED

  • Silk JS, Tan PZ, Ladouceur CD, Meller S, Siegle GJ, McMakin DL, Forbes EE, Dahl RE, Kendall PC, Mannarino A, Ryan ND. A Randomized Clinical Trial Comparing Individual Cognitive Behavioral Therapy and Child-Centered Therapy for Child Anxiety Disorders. J Clin Child Adolesc Psychol. 2018 Jul-Aug;47(4):542-554. doi: 10.1080/15374416.2016.1138408. Epub 2016 Mar 16.

    PMID: 26983904DERIVED

MeSH Terms

Conditions

Generalized Anxiety DisorderAnxiety, SeparationPhobia, Social

Interventions

Cognitive Behavioral TherapyPerson-Centered Psychotherapy

Condition Hierarchy (Ancestors)

Anxiety DisordersMental DisordersNeurodevelopmental DisordersPhobic Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Neal D Ryan, MD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Joaquim Puig-Antich Professor of Psychiatry

Study Record Dates

First Submitted

October 16, 2008

First Posted

October 17, 2008

Study Start

October 1, 2008

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

July 18, 2014

Record last verified: 2014-07

Locations

US(1)