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Effectiveness of a Family-Based Treatment for Preventing Anxiety Disorders in At-Risk Children

Primary Purpose

Anxiety Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Family-based CBT
Information Monitoring
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anxiety Disorders focused on measuring Anxiety

Eligibility Criteria

6 Years - 13 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Parents of child participant have a current, primary anxiety disorder

Exclusion Criteria:

  • Child has an anxiety disorder or is currently in treatment for anxiety

Sites / Locations

  • The Johns Hopkins University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Family-based CBT

Information Monitoring

Arm Description

Family-based CBT. Participants will receive family-based cognitive behavioral therapy. Families in this group will learn about how to identify the signs and symptoms of anxiety, ways to cope with anxiety, relaxation techniques, and problem-solving skills. They will participate in 8, one-hour sessions, once/week with trained clinicians and 3 monthly booster sessions to reinforce what they learned.

Information Monitoring. Participants will receive a packet of information about anxiety. Participants in this group will be called monthly to monitor symptoms of anxiety.

Outcomes

Primary Outcome Measures

Anxiety Disorders Interview Schedule for Diagnostic and Statistical Manual for Psychological Disorders-IV, Child and Parent Versions (C/P-ADIS)
The C/P-ADIS is a semi-structured diagnostic interview used to assess symptoms of anxiety, depression, and behavioral issues. This interview will be administered by a trained staff member and will utilize information from both parents and children. This interview will be used to determine the presence or absence of an anxiety disorder for children in this study. .

Secondary Outcome Measures

Full Information

First Posted
February 18, 2009
Last Updated
March 23, 2017
Sponsor
Johns Hopkins University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00847561
Brief Title
Effectiveness of a Family-Based Treatment for Preventing Anxiety Disorders in At-Risk Children
Official Title
Family-Based Prevention for Childhood Anxiety
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johns Hopkins University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will test the effectiveness of a family-based, cognitive behavioral therapy (CBT)-based program for preventing anxiety disorders in at-risk children.
Detailed Description
Anxiety disorders are among the most common mental disorders in children and adolescents, and they are associated with short- and long-term impairment in social, academic, familial, and psychological functioning. The children of parents with anxiety disorders are more likely to develop anxiety disorders themselves, because of genetic factors and the atmosphere in which they are raised. Previous research indicates that the risk of anxiety disorders among children can be reduced through preventive therapeutic interventions. In children with anxiety disorders whose parents also have anxiety disorders, therapy that includes their family is more successful than therapy focused only on the child. This study will test the effectiveness of a preventive, family-based therapy for children whose parents have anxiety disorders. Participation in this study will last 1 year. First, interested participants will be asked to perform a screening assessment. This will include providing information about the symptoms, behaviors, and functioning of parent and child participants; filling out questionnaires; and videotaping the child and parent participants interacting. If, after the screening, participants are selected to continue with the study, they will be randomly assigned to receive either information monitoring or family-based cognitive behavioral therapy. Child and parent participants assigned to information monitoring will receive a booklet with information on coping with anxiety. Child and parent participants assigned to family-based cognitive behavioral therapy will meet with a study clinician for eight, weekly, 1-hour intervention visits, during which participants will learn skills to reduce anxiety. After completing the weekly visits, participants in this group will also receive three monthly booster sessions, in which coping skills will be reviewed. In addition to the screening visit, all participants will undergo identical assessments at three more time periods: 9 weeks, 6 months, and 12 months after entering the study. All participants will also receive monthly phone calls throughout the study to monitor the children's anxiety symptoms.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders
Keywords
Anxiety

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
136 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Family-based CBT
Arm Type
Experimental
Arm Description
Family-based CBT. Participants will receive family-based cognitive behavioral therapy. Families in this group will learn about how to identify the signs and symptoms of anxiety, ways to cope with anxiety, relaxation techniques, and problem-solving skills. They will participate in 8, one-hour sessions, once/week with trained clinicians and 3 monthly booster sessions to reinforce what they learned.
Arm Title
Information Monitoring
Arm Type
Placebo Comparator
Arm Description
Information Monitoring. Participants will receive a packet of information about anxiety. Participants in this group will be called monthly to monitor symptoms of anxiety.
Intervention Type
Behavioral
Intervention Name(s)
Family-based CBT
Intervention Description
Eight, 1-hour weekly sessions with a trained clinician.
Intervention Type
Behavioral
Intervention Name(s)
Information Monitoring
Intervention Description
Packet providing information on strategies for coping with anxiety
Primary Outcome Measure Information:
Title
Anxiety Disorders Interview Schedule for Diagnostic and Statistical Manual for Psychological Disorders-IV, Child and Parent Versions (C/P-ADIS)
Description
The C/P-ADIS is a semi-structured diagnostic interview used to assess symptoms of anxiety, depression, and behavioral issues. This interview will be administered by a trained staff member and will utilize information from both parents and children. This interview will be used to determine the presence or absence of an anxiety disorder for children in this study. .
Time Frame
12 months post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Parents of child participant have a current, primary anxiety disorder Exclusion Criteria: Child has an anxiety disorder or is currently in treatment for anxiety
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Golda S. Ginsburg, PhD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Johns Hopkins University School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34647197
Citation
Slade EP, Ginsburg GS, Riddle MA. Cost-benefit Analysis of the Coping and Promoting Strength Program. Prev Sci. 2021 Nov;22(8):1096-1107. doi: 10.1007/s11121-021-01309-5. Epub 2021 Oct 14.
Results Reference
derived
PubMed Identifier
33070244
Citation
Ginsburg GS, Tein JY, Riddle MA. Preventing the Onset of Anxiety Disorders in Offspring of Anxious Parents: A Six-Year Follow-up. Child Psychiatry Hum Dev. 2021 Aug;52(4):751-760. doi: 10.1007/s10578-020-01080-8. Epub 2020 Oct 18.
Results Reference
derived
PubMed Identifier
28145769
Citation
Schleider JL, Ginsburg GS, Drake K. Perceived Peer Victimization Predicts Anxiety Outcomes in a Prevention Program for Offspring of Anxious Parents. J Clin Child Adolesc Psychol. 2018;47(sup1):S255-S263. doi: 10.1080/15374416.2016.1270831. Epub 2017 Feb 1.
Results Reference
derived
PubMed Identifier
26404420
Citation
Ginsburg GS, Drake KL, Tein JY, Teetsel R, Riddle MA. Preventing Onset of Anxiety Disorders in Offspring of Anxious Parents: A Randomized Controlled Trial of a Family-Based Intervention. Am J Psychiatry. 2015 Dec;172(12):1207-14. doi: 10.1176/appi.ajp.2015.14091178. Epub 2015 Sep 25.
Results Reference
derived

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Effectiveness of a Family-Based Treatment for Preventing Anxiety Disorders in At-Risk Children

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