Anxiety DisordersNCT00847561
Effectiveness of a Family-Based Treatment for Preventing Anxiety Disorders in At-Risk Children
A study testing Family-based CBT and Information Monitoring in people with Anxiety Disorders, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 13 years
- Conditions the study is for
- Anxiety Disorders
- What is being tested?
- Family-based CBT and Information Monitoring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 136 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to May 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Parents of child participant have a current, primary anxiety disorder
Who cannot join
- Child has an anxiety disorder or is currently in treatment for anxiety
Trial locations and contacts
1 site in 1 country.
United States1 site
The Johns Hopkins University School of Medicine
Baltimore, Maryland, 21205
About this study
Official title: Family-Based Prevention for Childhood Anxiety
This study will test the effectiveness of a family-based, cognitive behavioral therapy (CBT)-based program for preventing anxiety disorders in at-risk children.
Read the 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.
- Conditions
- Anxiety Disorders
- Being tested
- Family-based CBT, Information Monitoring
- Keywords
- Anxiety
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family-based CBTBehavioural
Eight, 1-hour weekly sessions with a trained clinician.
Information MonitoringBehavioural
Packet providing information on strategies for coping with anxiety
| Study group | Role | What they receive |
|---|---|---|
| Family-based CBT | Experimental | 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. Receives: Behavioral: Family-based CBT |
| Information Monitoring | Placebo comparator | Information Monitoring. Participants will receive a packet of information about anxiety. Participants in this group will be called monthly to monitor symptoms of anxiety. Receives: Behavioral: Information Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
.
Measured: 12 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2009 (estimated)
- Study startAug 2008
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Golda S. Ginsburg, Ph.D., Johns Hopkins University
- Investigators
- Golda S. Ginsburg, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00847561
- Sponsor's protocol ID
- R01MH077312
- Other IDs
- R01MH077312, R01MH077312-01, DDTR B4-TBI
- Status last verified
- Mar 2017
- First submitted
- 18 Feb 2009
- Last updated
- 24 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 34647197Ginsburg 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.
PubMed 33070244Schleider 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.
PubMed 28145769Ginsburg 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.
PubMed 26404420
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family-Based Prevention for Childhood Anxiety
- ClinicalTrials.gov ID
- NCT00847561
- Acronym / sponsor ID
- R01MH077312
- Conditions
- Anxiety Disorders
- Keywords
- Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Aug 2008
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 19 Feb 2009 (estimated)
- Results
- Posted 3 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Family-based CBT | Experimental | Behavioral: Family-based CBTFamily-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 | Placebo comparator | Behavioral: Information MonitoringInformation Monitoring. Participants will receive a packet of information about anxiety. Participants in this group will be called monthly to monitor symptoms of anxiety. |
Who may qualify
- Ages
- 6 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Parents of child participant have a current, primary anxiety disorder
Key exclusion criteria (1 listed)
- Child has an anxiety disorder or is currently in treatment for anxiety
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family-based CBTEight, 1-hour weekly sessions with a trained clinician. | Behavioural | Family-based CBT |
| Information MonitoringPacket providing information on strategies for coping with anxiety | Behavioural | Information Monitoring |
Primary outcome
Anxiety Disorders Interview Schedule for Diagnostic and Statistical Manual for Psychological Disorders-IV, Child and Parent Versions (C/P-ADIS)
Time frame: 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. .
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34647197Slade 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.
- Derived from this study: PubMed 33070244Ginsburg 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.
- Derived from this study: PubMed 28145769Schleider 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.
- Derived from this study: PubMed 26404420Ginsburg 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Golda S. Ginsburg, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family-based CBT and Information Monitoring in people with Anxiety Disorders, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety Disorders Interview Schedule for Diagnostic and Statistical Manual for Psychological Disorders-IV, Child and Parent Versions (C/P-ADIS) (time frame: 12 months post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00847561, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2017.