Completed

Family-Based Prevention Program for Childhood Anxiety

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What is being tested

Family-Based Anxiety Prevention Program

+ Evaluation only
Behavioral
Who is being recruted

Anxiety Disorders

Over 7 Years
+5 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Prevention Study

Interventional
Study Start: September 2003

See protocol details

Summary

Principal SponsorJohns Hopkins University
Last updated: February 7, 2018
Sourced from a government-validated database.Claim as a partner
Study start date: September 1, 2003Actual date on which the first participant was enrolled.

This study will evaluate the effectiveness of a short-term family-based program for preventing anxiety disorders in at-risk children. Anxiety disorders are serious conditions that can negatively impact a person's overall functioning. This study will enroll mothers with anxiety disorders and their children to determine whether a brief family-based intervention will reduce childhood anxiety better than standard care. Participants will be randomly assigned to either the family-based prevention program or to evaluation only for 8 weeks. Participants in the prevention program will have weekly sessions with a therapist and will learn skills to help reduce anxiety. Self- and parent-reports, diagnostic interviews, a computerized memory task, and a videotaped parent-child interaction task will be used to assess participants. Assessments will be conducted at study start and one week after intervention completion (Week 9). Follow-up visits will be conducted at 6 and 12 months after intervention completion.

Official TitleFamily-Based Prevention for Childhood Anxiety 
Principal SponsorJohns Hopkins University
Last updated: February 7, 2018
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
40 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Prevention Study
Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

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 effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

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.
Over 7 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
2 inclusion criteria required to participate
Mothers with a current, primary anxiety disorder
7-12 year old children without an anxiety disorder
3 exclusion criteria prevent from participating
Mothers that do not have a current, primary anxiety disorder
7-12 year old children with an anxiety disorder
7-12 year old children that are currently receiving treatment for anxiety that could interfere with the study

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
2 intervention groups 

are designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
Participants will complete an 8 session (1 session/week), cognitive behavioral therapy-based, family prevention program to be administered by a trained clinician, after randomization to the study. The prevention program will include 3 booster sessions that take place after the first 8 sessions.
Group II
Active Comparator
Waitlist control group. Participants in this group will receive general information (in the form of a printed packet) about anxiety after randomization to the study. Families in this group will complete all study evaluations and will then be offered the option of participating in the prevention program. Families who accept will begin the prevention sessions and will receive the same CBT-based, family-based prevention program as the other treatment arm.
Study Objectives
Primary Objectives

Measured by the Anxiety Disorder Interview Schedule for the Diagnostic and Statistical Manual of Mental Disorders 4th edition, child and parent versions.

The cumulative number of children who developed an anxiety disorder at each assessment point during the study. Using the intent to treat sample, a total of 6 children in the non-intervention group developed an anxiety disorder by the 12-month assessment. No children in the CAPS group developed an anxiety disorder.

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
Johns Hopkins University School of MedicineBaltimore, United StatesSee the location
CompletedOne Study Center