Anxiety DisordersNCT00620958
Cognitive Behavioral Therapy With Parental Involvement for Treating Children With Anxiety Disorders
A study testing Individual cognitive behavioral therapy (ICBT), Parent relationship training (PRT2) With Individual Cognitive Behavioral Therapy (ICBT) and Parent reinforcement training (PRT1) With Individual Cognitive Behavioral Therapy (ICBT) in people with Anxiety Disorders, run by Florida International University at 1 site in United States.
Trial summary
This study will compare the effectiveness of individual cognitive behavioral therapy with two distinct types of parent involvement versus individual cognitive behavioral therapy without parent involvement in treating children with anxiety disorders. Read more about this study
- Who is it for?
- Ages 8 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety Disorders
- What is being tested?
- Individual cognitive behavioral therapy (ICBT), Parent relationship training (PRT2) With Individual Cognitive Behavioral Therapy (ICBT) and Parent reinforcement training (PRT1) With Individual Cognitive Behavioral Therapy (ICBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 341 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 8 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Meets DSM-IV criteria for a primary diagnosis of an anxiety disorder, including generalized anxiety disorder (GAD), social phobia (SOP), and social anxiety disorder (SAD), as confirmed by ADIS C/P
- Receives a mean score of 4 or greater on the Clinician's Rating Scale of Severity (CSR)
- Willing to stop all other child psychosocial treatment upon study entry
- Comorbid attention deficit hyperactivity disorder (ADHD) and depressive disorders with CSR scores less than 4 are acceptable if treated and stable
- Tics or aggression/impulse control problems with minimal or no impairment are acceptable if treated and stable
- If taking medication, on stable medication treatment for comorbid ADHD, major depressive disorder, tics, or aggression/impulse control
- Agreement of parents or guardians to participate in the child participant's treatment
- Child living with a primary caregiver who has known the child well for at least 6 months and who is legally able to give consent for the child's participation
Who cannot join
- Meets as a primary diagnosis any Axis I DSM-IV disorder other than GAD, SOP, and SAD
- Child and/or parent meets diagnoses (e.g., primary, secondary, tertiary) for any one of the following: pervasive developmental disorders, mental retardation, selective mutism, organic mental disorders, schizophrenia, and other psychotic disorders
- Child and/or parent shows high likelihood and/or serious intent of hurting self or others
- Full-scale IQ score less than 80
- Victim of previously undisclosed abuse requiring investigation or ongoing supervision by the Department of Social Services
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida International University
Miami, Florida, 33139
About this study
Official title: Parent Mediation of Child Anxiety CBT Outcome
This study will compare the effectiveness of individual cognitive behavioral therapy with two distinct types of parent involvement versus individual cognitive behavioral therapy without parent involvement in treating children with anxiety disorders. Hypothesized mediator of change for eac of the two parent treatment conditions also will be evaluated
Read the detailed description
Anxiety disorders are among the most common emotional, behavioral, and mental disorders in children, affecting an estimated 1 out of every 10 children and adolescents. Symptoms of anxiety disorders include an excessive sense of worry, stress, and fear; headache; nausea; and impaired learning and concentration. If left untreated, anxiety disorders can lead to difficulties with school and relationships, substance abuse, and the persistence of anxiety problems into adulthood. Individual cognitive behavioral therapy (ICBT), in which children learn to cope with fears through behavior and thought modification, has been an effective form of treatment for children with anxiety disorders. Studies have indicated that ICBT involving children and parents may be more effective than ICBT involving only children for improving anxiety levels and long-term recovery rates. This study will compare the effectiveness of ICBT with either parent reinforcement training or parent relationship training versus ICBT without parent involvement in treating children with anxiety disorders.
Participation in this study will last 15 months, with 3 months of treatment and 12 months of follow-up. Both parent and child participants will first undergo initial assessments that will include psychological questionnaires; a video-taped child-parent interaction session; and interviews about behaviors, psychological functioning, and problem situations. Participants will then be assigned randomly to one of three treatment groups: ICBT, ICBT with parent reinforcement training (PRT1), or ICBT with parent relationship training (PRT2). All participants will attend between 12 and 14 weekly treatment sessions, lasting 60 minutes each. During all sessions, child participants will learn how to change anxious and fearful thoughts and to deal with feared objects and events. ICBT PRT1 and ICBT PRT2 sessions will also involve the parent and child working together. ICBT PRT1 will specifically teach the parent strategies for managing the child's behavior through the use of positive rewards and positive parental behaviors to help discourage child avoidant behaviors. ICBT PRT2 will specifically teach the parent ways to communicate with the child and to solve problems to help discourage child avoidant behaviors.
All participants will be asked to complete questionnaires throughout treatment, upon completion of treatment, and 6 months after the end of treatment. Three and 9 months after the end of treatment, participants will undergo a 15-minute telephone assessment to evaluate how the child participant has been doing. The final assessment will occur 12 months after the end of treatment and will include repeat interviews and questionnaires.
- Conditions
- Anxiety Disorders
- Being tested
- Individual cognitive behavioral therapy (ICBT), Parent relationship training (PRT2) With Individual Cognitive Behavioral Therapy (ICBT), Parent reinforcement training (PRT1) With Individual Cognitive Behavioral Therapy (ICBT)
- Keywords
- Mediation, Outcome, CBT, Child Anxiety Intervention
- Medical subject headings
- Anxiety Disorders, Negotiating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individual cognitive behavioral therapy (ICBT)Behavioural
Also called CBT
ICBT will include 12 to 14 sessions during which child participants will learn how to change anxious and fearful thoughts and to deal with feared objects and events.
Parent relationship training (PRT2) With Individual Cognitive Behavioral Therapy (ICBT)Behavioural
Parent relationship training will teach the parent ways to communicate with the child and to solve problems to help discourage child avoidant behaviors. ICBT will include 12 to 14 sessions during which child participants will learn how to change anxious and fearful thoughts and to deal with feared objects and events.
Parent reinforcement training (PRT1) With Individual Cognitive Behavioral Therapy (ICBT)Behavioural
Parent reinforcement training will teach the parent strategies for managing the child's behavior through the use of positive rewards and positive parental behaviors to help discourage child avoidant behaviors. ICBT will include 12 to 14 sessions during which child participants will learn how to change anxious and fearful thoughts and to deal with feared objects and events.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants will receive individual cognitive behavioral therapy with parent reinforcement training. Receives: Behavioral: Parent reinforcement training (PRT1) With Individual Cognitive Behavioral Therapy (ICBT) |
| 2 | Experimental | Participants will receive individual cognitive behavioral therapy with parent relationship training. Receives: Behavioral: Parent relationship training (PRT2) With Individual Cognitive Behavioral Therapy (ICBT) |
| 3 | Active comparator | Participants will receive individual cognitive behavioral therapy alone. Receives: Behavioral: Individual cognitive behavioral therapy (ICBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician Severity Rating on the Anxiety Disorders Interview Schedule for Children (ADIS C/P)
Measured: Measured at pretreatment, midtreatment, post-treatment, and Year 1 follow up
Secondary outcomes (1)
Child Manifest Anxiety Scale for Children, Revised
Measured: Measured at pretreatment, midtreatment, post-treatment, and Year 1 follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2008 (estimated)
- Study startAug 2008
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 341 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida International University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Wendy Silverman, Florida International University
- Investigators
- Wendy K. Silverman, PhD, Principal investigator, Florida International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00620958
- Sponsor's protocol ID
- R01MH079943
- Other IDs
- R01MH079943, DSIR 84-CTS, 1R01MH079943-01A1
- Status last verified
- Jul 2017
- First submitted
- 20 Feb 2008
- Last updated
- 2 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Patriarca GC, Rey Y, Marin CE, Yeguez CE, Pettit JW, Silverman WK. Parent involvement enhances CBTs for anxiety disorders in Hispanic/Latino youth: Acculturation as a moderator. J Consult Clin Psychol. 2022 Oct;90(10):827-836. doi: 10.1037/ccp0000770.
PubMed 36355650
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parent Mediation of Child Anxiety CBT Outcome
- ClinicalTrials.gov ID
- NCT00620958
- Acronym / sponsor ID
- R01MH079943
- Conditions
- Anxiety Disorders
- Keywords
- Mediation, Outcome, CBT, Child Anxiety Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 341 participants (actual)
- Lead sponsor
- Florida International UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Aug 2008
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 22 Feb 2008 (estimated)
- Results
- Not posted in the source record
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 compare the effectiveness of individual cognitive behavioral therapy with two distinct types of parent involvement versus individual cognitive behavioral therapy without parent involvement in treating children with anxiety disorders. Hypothesized mediator of change for eac of the two parent treatment conditions also will be evaluated
Detailed description
Anxiety disorders are among the most common emotional, behavioral, and mental disorders in children, affecting an estimated 1 out of every 10 children and adolescents. Symptoms of anxiety disorders include an excessive sense of worry, stress, and fear; headache; nausea; and impaired learning and concentration. If left untreated, anxiety disorders can lead to difficulties with school and relationships, substance abuse, and the persistence of anxiety problems into adulthood. Individual cognitive behavioral therapy (ICBT), in which children learn to cope with fears through behavior and thought modification, has been an effective form of treatment for children with anxiety disorders. Studies have indicated that ICBT involving children and parents may be more effective than ICBT involving only children for improving anxiety levels and long-term recovery rates. This study will compare the effectiveness of ICBT with either parent reinforcement training or parent relationship training versus ICBT without parent involvement in treating children with anxiety disorders.
Participation in this study will last 15 months, with 3 months of treatment and 12 months of follow-up. Both parent and child participants will first undergo initial assessments that will include psychological questionnaires; a video-taped child-parent interaction session; and interviews about behaviors, psychological functioning, and problem situations. Participants will then be assigned randomly to one of three treatment groups: ICBT, ICBT with parent reinforcement training (PRT1), or ICBT with parent relationship training (PRT2). All participants will attend between 12 and 14 weekly treatment sessions, lasting 60 minutes each. During all sessions, child participants will learn how to change anxious and fearful thoughts and to deal with feared objects and events. ICBT PRT1 and ICBT PRT2 sessions will also involve the parent and child working together. ICBT PRT1 will specifically teach the parent strategies for managing the child's behavior through the use of positive rewards and positive parental behaviors to help discourage child avoidant behaviors. ICBT PRT2 will specifically teach the parent ways to communicate with the child and to solve problems to help discourage child avoidant behaviors.
All participants will be asked to complete questionnaires throughout treatment, upon completion of treatment, and 6 months after the end of treatment. Three and 9 months after the end of treatment, participants will undergo a 15-minute telephone assessment to evaluate how the child participant has been doing. The final assessment will occur 12 months after the end of treatment and will include repeat interviews and questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Parent reinforcement training (PRT1) With Individual Cognitive Behavioral Therapy (ICBT)Participants will receive individual cognitive behavioral therapy with parent reinforcement training. |
| 2 | Experimental | Behavioral: Parent relationship training (PRT2) With Individual Cognitive Behavioral Therapy (ICBT)Participants will receive individual cognitive behavioral therapy with parent relationship training. |
| 3 | Active comparator | Behavioral: Individual cognitive behavioral therapy (ICBT)Participants will receive individual cognitive behavioral therapy alone. |
Who may qualify
- Ages
- 8 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Meets DSM-IV criteria for a primary diagnosis of an anxiety disorder, including generalized anxiety disorder (GAD), social phobia (SOP), and social anxiety disorder (SAD), as confirmed by ADIS C/P
- Receives a mean score of 4 or greater on the Clinician's Rating Scale of Severity (CSR)
- Willing to stop all other child psychosocial treatment upon study entry
- Comorbid attention deficit hyperactivity disorder (ADHD) and depressive disorders with CSR scores less than 4 are acceptable if treated and stable
- Tics or aggression/impulse control problems with minimal or no impairment are acceptable if treated and stable
Key exclusion criteria (5 listed)
- Meets as a primary diagnosis any Axis I DSM-IV disorder other than GAD, SOP, and SAD
- Child and/or parent meets diagnoses (e.g., primary, secondary, tertiary) for any one of the following: pervasive developmental disorders, mental retardation, selective mutism, organic mental disorders, schizophrenia, and other psychotic disorders
- Child and/or parent shows high likelihood and/or serious intent of hurting self or others
- Full-scale IQ score less than 80
- Victim of previously undisclosed abuse requiring investigation or ongoing supervision by the Department of Social Services
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 |
|---|---|---|
| Individual cognitive behavioral therapy (ICBT)Also: CBTICBT will include 12 to 14 sessions during which child participants will learn how to change anxious and fearful thoughts and to deal with feared objects and events. | Behavioural | 3 |
| Parent relationship training (PRT2) With Individual Cognitive Behavioral Therapy (ICBT)Parent relationship training will teach the parent ways to communicate with the child and to solve problems to help discourage child avoidant behaviors. ICBT will include 12 to 14 sessions during which child participants will learn how to change anxious and fearful thoughts and to deal with feared objects and events. | Behavioural | 2 |
| Parent reinforcement training (PRT1) With Individual Cognitive Behavioral Therapy (ICBT)Parent reinforcement training will teach the parent strategies for managing the child's behavior through the use of positive rewards and positive parental behaviors to help discourage child avoidant behaviors. ICBT will include 12 to 14 sessions during which child participants will learn how to change anxious and fearful thoughts and to deal with feared objects and events. | Behavioural | 1 |
Primary outcome
Clinician Severity Rating on the Anxiety Disorders Interview Schedule for Children (ADIS C/P)
Time frame: Measured at pretreatment, midtreatment, post-treatment, and Year 1 follow up
1 secondary outcome
Child Manifest Anxiety Scale for Children, Revised
Time frame: Measured at pretreatment, midtreatment, post-treatment, and Year 1 follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2017.
- Derived from this study: PubMed 36355650Patriarca GC, Rey Y, Marin CE, Yeguez CE, Pettit JW, Silverman WK. Parent involvement enhances CBTs for anxiety disorders in Hispanic/Latino youth: Acculturation as a moderator. J Consult Clin Psychol. 2022 Oct;90(10):827-836. doi: 10.1037/ccp0000770.
Related trials for Anxiety Disorders
Recruiting
Electroacupuncture for Generalized Anxiety Disorder: Clinical Efficacy and Neuroimaging Mechanisms
Generalized Anxiety Disorder
Recruiting
Effects of Connective Tissue Massage Plus Biofeedback for Dyssynergic Defecation
Dyssynergic Defecation
RecruitingObservational study
Development of Magnetic Resonance Imaging Techniques for Studying Mood and Anxiety Disorders
Mood Disorders, Anxiety Disorders
RecruitingPhase 2
Study of Neuro-Cognitive Correlates of Pediatric Anxiety Disorders
Anxiety Disorders, Major Depressive Disorder
Recruiting
Virtual Reality Intervention to Improve Psychological Symptom Burden for Cancer Patients Undergoing Treatment
Adjustment Disorder, Anxiety Disorder
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.
Wendy K. Silverman, PhD principal investigator
Florida International 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 Individual cognitive behavioral therapy (ICBT), Parent relationship training (PRT2) With Individual Cognitive Behavioral Therapy (ICBT) and Parent reinforcement training (PRT1) With Individual Cognitive Behavioral Therapy (ICBT) in people with Anxiety Disorders, run by Florida International 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 8 inclusion and 5 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 2 Aug 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Clinician Severity Rating on the Anxiety Disorders Interview Schedule for Children (ADIS C/P) (time frame: Measured at pretreatment, midtreatment, post-treatment, and Year 1 follow up). 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 NCT00620958, which also lists 1 linked publication.
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 2 Aug 2017.