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

• Sponsor: Johns Hopkins University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00847561
• Collaborator: National Institute of Mental Health (NIMH) (NIH)
• Enrollment: 136
• Location: 1
• Arms: 2
• Duration (Months): 69
• Patients Per Site Per Month: 2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Anxiety Disorders	Behavioral: Family-based CBT; Behavioral: Information Monitoring	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 136 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Family-Based Prevention for Childhood Anxiety
• Study Start Date: Aug 1, 2008
• Actual Primary Completion Date: May 1, 2014
• Actual Study Completion Date: May 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Family-based CBT 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.	Behavioral: Family-based CBT; Eight, 1-hour weekly sessions with a trained clinician.
Placebo Comparator: Information Monitoring Information Monitoring. Participants will receive a packet of information about anxiety. Participants in this group will be called monthly to monitor symptoms of anxiety.	Behavioral: Information Monitoring; Packet providing information on strategies for coping with anxiety

Outcome Measures

Primary Outcome Measures

1. Anxiety Disorders Interview Schedule for Diagnostic and Statistical Manual for Psychological Disorders-IV, Child and Parent Versions (C/P-ADIS) [12 months post-treatment]

   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. .

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 13 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Johns Hopkins University School of Medicine	Baltimore	Maryland	United States	21205

Sponsors and Collaborators

• Johns Hopkins University
• National Institute of Mental Health (NIMH)

Investigators

• Principal Investigator: Golda S. Ginsburg, PhD, Johns Hopkins University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• CAPS Website

Publications

None provided.

• Responsible Party: Golda S. Ginsburg, Ph.D., Professor, Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT00847561
• Other Study ID Numbers: R01MH077312; R01MH077312; R01MH077312-01; DDTR B4-TBI
• First Posted: Feb 19, 2009
• Last Update Posted: Mar 24, 2017
• Last Verified: Mar 1, 2017

• Keywords provided by Golda S. Ginsburg, Ph.D., Professor, Johns Hopkins University: Anxiety
• Additional relevant MeSH terms: Anxiety Disorders

Study Results

Participant Flow

Arm/Group Title	Family-based CBT	Information Monitoring
Arm/Group Description	Family-based Cognitive Behavioral Therapy (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. Family-based CBT: Eight, 1-hour weekly sessions with a trained clinician.	Information Monitoring. Participants will receive a packet of information about anxiety. Participants in this group will be called monthly to monitor symptoms of anxiety. Information Monitoring: Packet providing information on strategies for coping with anxiety
Period Title: Overall Study
STARTED	70	66
COMPLETED	57	62
NOT COMPLETED	13	4

Baseline Characteristics

Arm/Group Title	Family-based CBT	Information Monitoring	Total
Arm/Group 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. Family-based CBT: Eight, 1-hour weekly sessions with a trained clinician.	Information Monitoring. Participants will receive a packet of information about anxiety. Participants in this group will be called monthly to monitor symptoms of anxiety. Information Monitoring: Packet providing information on strategies for coping with anxiety	Total of all reporting groups
Overall Participants	70	66	136
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	8.53 (7.76)	8.86 (1.85)	8.69 (1.80)
Sex: Female, Male (Count of Participants)
Female	44 62.9%	32 48.5%	76 55.9%
Male	26 37.1%	34 51.5%	60 44.1%
Race/Ethnicity, Customized (participants) [Number]
Caucasian	58 82.9%	57 86.4%	115 84.6%
other ethnicity/race	12 17.1%	9 13.6%	21 15.4%
Region of Enrollment (participants) [Number]
United States	70 100%	66 100%	136 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Information Monitoring	Family-based CBT
Arm/Group 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. Information Monitoring: Packet providing information on strategies for coping with anxiety	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. Family-based CBT: Eight, 1-hour weekly sessions with a trained clinician.
Measure Participants	66	70
Number [participants with anxiety diagnosis]	19 27.1%	3 4.5%

Adverse Events

Arm/Group Title	Family-based CBT		Information Monitoring
Arm/Group 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. Family-based CBT: Eight, 1-hour weekly sessions with a trained clinician.		Information Monitoring. Participants will receive a packet of information about anxiety. Participants in this group will be called monthly to monitor symptoms of anxiety. Information Monitoring: Packet providing information on strategies for coping with anxiety
All Cause Mortality
	Family-based CBT		Information Monitoring
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Family-based CBT		Information Monitoring
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/70 (0%)		0/66 (0%)
Other (Not Including Serious) Adverse Events
	Family-based CBT		Information Monitoring
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/70 (0%)		0/66 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.