Trial Outcomes & Findings for Family-Based Prevention Program for Childhood Anxiety (NCT NCT00078728)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

40 participants

Primary outcome timeframe

12 month

Results posted on

2018-02-07

Participant Flow

Participant milestones

Participant milestones
Measure	1 Family-based Prevention Program 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.	2 Evaluation Only Evaluation only : Participants will undergo evaluations without active treatment for 8 weeks.
Overall Study STARTED	20	20
Overall Study COMPLETED	16	17
Overall Study NOT COMPLETED	4	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Family-Based Prevention Program for Childhood Anxiety

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	1 Family-based Prevention Program n=20 Participants 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.	2 Evaluation Only n=20 Participants Evaluation only : Participants will undergo evaluations without active treatment for 8 weeks.	Total n=40 Participants Total of all reporting groups
Age, Categorical <=18 years	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	9.20 years STANDARD_DEVIATION 1.91 • n=5 Participants	8.68 years STANDARD_DEVIATION 1.81 • n=7 Participants	8.94 years STANDARD_DEVIATION 1.85 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	8 Participants n=7 Participants	18 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	12 Participants n=7 Participants	22 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants	20 participants n=7 Participants	40 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 month

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

Outcome measures

Outcome measures
Measure	1 Family-based Prevention Program n=20 Participants 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.	2 Evaluation Only n=20 Participants Evaluation only : Participants will undergo evaluations without active intervention for 8 weeks but received an informational packet on anxiety disorders.
Number of Children With Child Anxiety Diagnosis	20 participants	20 participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	1 Family-based Prevention Program n=20 Participants 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.	2 Evaluation Only n=20 Participants Evaluation only : Participants will undergo evaluations without active intervention for 8 weeks but received an informational packet on anxiety disorders.
Child Anxiety Diagnoses	0 participants	6 participants

Adverse Events

1 Family-based Prevention Program

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

2 Evaluation Only

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Golda Ginsburg, PhD,Professor

The Johns Hopkins University School of Medicine

Phone: 410-955-1544

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place