Completed

Individual and Family Therapy for Children With Anxiety Disorders

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Individual Child CBT

+ Family CBT
+ Education/Support/Attention
Behavioral
Who is being recruted

Anxiety

From 9 to 13 Years

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: July 2000

See protocol details

Summary

Principal SponsorTemple University
Last updated: March 6, 2014
Sourced from a government-validated database.Claim as a partner
Study start date: July 1, 2000Actual date on which the first participant was enrolled.

The purpose of this study is to compare three treatments to determine which is most effective in reducing anxiety in children. Children and their parents will complete a comprehensive diagnostic assessment to determine eligibility. The assessment will include an individual diagnostic interview with the child, interviews with the parents, and written observations of the child from family members and teachers. Participants will then be randomly assigned to receive individual cognitive behavioral therapy (ICBT), family CBT (FCBT), or education/support/attention (ESA) for 5 months. Children in the ICBT group will meet individually with a therapist. In the FCBT and ESA treatment groups, children and their parents will meet weekly with a therapist. At the end of treatment and 1 year following treatment completion, families will complete another assessment to determine the effectiveness of each treatment at reducing short- and long-term anxiety symptoms in their children.

Official TitleChild and Family Therapy for Anxiety-Disordered Youth 
Principal SponsorTemple University
Last updated: March 6, 2014
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
150 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 placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
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
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same 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 9 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
Criteria

Inclusion Criteria: * Child with DSM-IV criteria for separation anxiety disorder, social phobia, or generalized anxiety disorder Exclusion Criteria for Child Participants: * IQ less than 80 * Current use of anti-anxiety or antidepressant medications * Psychotic symptoms * Child and/or parent is non-English speaking

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 1 location
Suspended
Temple University Child and Adolescent Anxiety Disorders ClinicPhiladelphia, United StatesSee the location
CompletedOne Study Center