Completed

Therapeutic Processes and Treatment Outcome in Adolescents With Anxiety Disorders

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What is being tested

Cognitive Behavioral Therapy

Behavioral
Who is being recruted

Anxiety Disorders

From 8 to 13 Years

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: September 2002

See protocol details

Summary

Principal SponsorTemple University
Last updated: November 7, 2013
Sourced from a government-validated database.Claim as a partner
Study start date: September 1, 2002Actual date on which the first participant was enrolled.

The purpose of this study is to examine the relationship between different aspects of cognitive behavior therapy (CBT) and treatment outcome. Anxiety disorders are common among children; if untreated, they can negatively affect children's lives. Evidence suggests that CBT can benefit children with anxiety disorders, but the causal mechanisms between therapy and beneficial outcomes have not been thoroughly investigated. Audio and videotaped sessions of children currently receiving CBT and those who received CBT in previous trials will be examined. Various rating scales will be used to rate therapeutic alliance, child involvement, and therapist flexibility for each session of CBT. To evaluate potential process variables that contribute to participant drop-out, this study will compare the early process variables for children who complete treatment and for those who discontinue treatment.

Official TitleProcess as a Predictor of Outcomes in CBT for Youth 
Principal SponsorTemple University
Last updated: November 7, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
130 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are assigned to groups based on specific criteria, such as their medical history or a doctor's recommendation. This approach ensures that treatments are given to those who may benefit the most, based on known factors.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 8 to 13 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Anxiety Disorders
Criteria

Inclusion criteria: * Diagnosis of separation anxiety disorder, generalized anxiety disorder, or social phobia * At least one English-speaking parent Exclusion criteria: * IQ \< 80 * Psychotic symptoms

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 2 locations
Suspended
Temple UniversityPhiladelphia, United StatesSee the location
Suspended
Macquarie UniversitySydney, Australia
Completed2 Study Centers