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

NCT ID: NCT00847561

Last Updated: 2017-03-24

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2014-05-31

Brief Summary

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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

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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.

Conditions

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Anxiety Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Family-based CBT

Intervention Type BEHAVIORAL

Eight, 1-hour weekly sessions with a trained clinician.

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.

Group Type PLACEBO_COMPARATOR

Information Monitoring

Intervention Type BEHAVIORAL

Packet providing information on strategies for coping with anxiety

Interventions

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Family-based CBT

Eight, 1-hour weekly sessions with a trained clinician.

Intervention Type BEHAVIORAL

Information Monitoring

Packet providing information on strategies for coping with anxiety

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Golda S. Ginsburg, Ph.D.

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Golda S. Ginsburg, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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The Johns Hopkins University School of Medicine

Baltimore, Maryland, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 34647197 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33070244 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28145769 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26404420 (View on PubMed)

Other Identifiers

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R01MH077312

Identifier Type: NIH

Identifier Source: secondary_id

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R01MH077312-01

Identifier Type: NIH

Identifier Source: secondary_id

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DDTR B4-TBI

Identifier Type: OTHER

Identifier Source: secondary_id

R01MH077312

Identifier Type: NIH

Identifier Source: org_study_id

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