Family-Based Prevention Program for Childhood Anxiety

• Sponsor: Johns Hopkins University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00078728
• Collaborator: National Institute of Mental Health (NIMH) (NIH)
• Enrollment: 40
• Location: 1
• Arms: 2
• Duration (Months): 46
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

This study will evaluate the effectiveness of a short-term family-based program for preventing anxiety disorders in at-risk children.

Condition or Disease	Intervention/Treatment	Phase
Anxiety Disorders	Behavioral: Family-Based Anxiety Prevention Program; Behavioral: Evaluation only	N/A

Detailed Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Family-Based Prevention for Childhood Anxiety
• Study Start Date: Sep 1, 2003
• Actual Primary Completion Date: Jul 1, 2007
• Actual Study Completion Date: Jul 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Family-based anxiety prevention program 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.	Behavioral: Family-Based Anxiety Prevention Program; Participants in the prevention program will have weekly sessions with a therapist and will learn skills to help reduce anxiety for 8 weeks. The intervention will begin immediately after randomization to the study.
Active Comparator: Evaluation only 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.	Behavioral: Evaluation only; Participants will undergo evaluations without active treatment for 8 weeks.

Outcome Measures

Primary Outcome Measures

1. Number of Children With Child Anxiety Diagnosis [12 month]

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

2. Child Anxiety Diagnoses [12 months]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 7 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Mothers with a current, primary anxiety disorder

• 7-12 year old children without an anxiety disorder

Exclusion Criteria:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Publications

None provided.

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT00078728
• Other Study ID Numbers: K23MH063427; K23MH063427
• First Posted: Mar 8, 2004
• Last Update Posted: Feb 7, 2018
• Last Verified: Jan 1, 2018

• Keywords provided by Johns Hopkins University: Anxiety
• Additional relevant MeSH terms: Anxiety Disorders

Study Results

Participant Flow

Arm/Group Title	1 Family-based Prevention Program	2 Evaluation Only
Arm/Group Description	Family-Based Anxiety Prevention Program : Participants in the prevention program will have weekly sessions with a therapist and will learn skills to help reduce anxiety for 8 weeks.	Evaluation only : Participants will undergo evaluations without active treatment for 8 weeks.
Period Title: Overall Study
STARTED	20	20
COMPLETED	16	17
NOT COMPLETED	4	3

Baseline Characteristics

Arm/Group Title	1 Family-based Prevention Program	2 Evaluation Only	Total
Arm/Group Description	Family-Based Anxiety Prevention Program : Participants in the prevention program will have weekly sessions with a therapist and will learn skills to help reduce anxiety for 8 weeks.	Evaluation only : Participants will undergo evaluations without active treatment for 8 weeks.	Total of all reporting groups
Overall Participants	20	20	40
Age (Count of Participants)
<=18 years	20 100%	20 100%	40 100%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	9.20 (1.91)	8.68 (1.81)	8.94 (1.85)
Sex: Female, Male (Count of Participants)
Female	10 50%	8 40%	18 45%
Male	10 50%	12 60%	22 55%
Region of Enrollment (participants) [Number]
United States	20 100%	20 100%	40 100%

Outcome Measures

1. Primary Outcome

Title	Number of Children With Child Anxiety Diagnosis
Description	Measured by the Anxiety Disorder Interview Schedule for the Diagnostic and Statistical Manual of Mental Disorders 4th edition, child and parent versions.
Time Frame	12 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	1 Family-based Prevention Program	2 Evaluation Only
Arm/Group Description	Family-Based Anxiety Prevention Program : Participants in the prevention program will have weekly sessions with a therapist and will learn skills to help reduce anxiety for 8 weeks.	Evaluation only : Participants will undergo evaluations without active intervention for 8 weeks but received an informational packet on anxiety disorders.
Measure Participants	20	20
Number [participants]	20 100%	20 100%

2. Primary Outcome

Title	Child Anxiety Diagnoses
Description	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.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	1 Family-based Prevention Program	2 Evaluation Only
Arm/Group Description	Family-Based Anxiety Prevention Program : Participants in the prevention program will have weekly sessions with a therapist and will learn skills to help reduce anxiety for 8 weeks.	Evaluation only : Participants will undergo evaluations without active treatment for 8 weeks.
Measure Participants	20	20
Number [participants]	0 0%	6 30%

Adverse Events

Arm/Group Title	1 Family-based Prevention Program		2 Evaluation Only
Arm/Group Description	Family-Based Anxiety Prevention Program : Participants in the prevention program will have weekly sessions with a therapist and will learn skills to help reduce anxiety for 8 weeks.		Evaluation only : Participants will undergo evaluations without active treatment for 8 weeks.
All Cause Mortality
	1 Family-based Prevention Program		2 Evaluation Only
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	1 Family-based Prevention Program		2 Evaluation Only
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)
Other (Not Including Serious) Adverse Events
	1 Family-based Prevention Program		2 Evaluation Only
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)

Limitations/Caveats

Of the 40 participants in the study, no adverse events occured or were reported.

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.