Back to resultsParent-based Treatment for Youth With Anxiety and Obsessive-compulsive Disorder
Primary Purpose
Obsessive-Compulsive Disorder in Children, Social Anxiety Disorder of Childhood, Obsessive-Compulsive Disorder in Adolescence
Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Standard SPACE
Bibliotherapy, low therapist contact SPACE
Sponsored by
About this trial
This is an interventional treatment trial for Obsessive-Compulsive Disorder in Children focused on measuring obsessive-compulsive disorder, children, cognitive behavioral therapy, anxiety
Eligibility Criteria
Inclusion Criteria:
- The child is between the ages of 7 to 17 at enrollment
- The child has clinically significant symptoms of anxiety and/or OCD, as indicated by a score of 12 or higher on the Pediatric Anxiety Rating Scale (PARS).
- The child is appropriate for anxiety-focused treatment (e.g., anxiety is the primary problem as diagnosed using the Anxiety Disorders Interview Schedule (ADIS), and if secondary psychopathology is present it will not interfere with treatment).
- One parent/guardian is able and willing to participate in assessment and treatment (e.g., has sufficient English fluency, the decisional capacity to participate, and can commit to treatment duration).
- The participating parent/guardian lives with their child at least 50% of the time.
- Both parent and child are able to read and understand English.
- The child is able to communicate verbally.
- Participants must reside in Texas and parents must be in the state of Texas when taking calls.
Exclusion Criteria:
- the child has a diagnosis of child lifetime bipolar disorder, drug of alcohol abuse, intellectual or developmental disability, psychotic disorder, or conduct disorder.
- the child has severe, current suicidal/homicidal ideation and/or self-injury requiring medical intervention (referrals will be made for appropriate clinical intervention).
- the child is receiving concurrent evidence-based psychotherapy for anxiety, involving exposure therapy in at least 50% of sessions.
- the child has initiated or changed dosage of psychotropic medications within 4 weeks before study enrollment OR stimulant or benzodiazepine medications within 2 weeks before study enrollment. If appropriate, the child may be enrolled in the study once medication dosage has stabilized (i.e., 4 weeks for psychotropic medication or 2 weeks for stimulant/benzodiazepine medication).
Sites / Locations
- Baylor College of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Standard SPACE
Bibliotherapy, low therapist contact SPACE
Arm Description
12 one hour parent sessions over 12 weeks in which the therapist guides the parent to target anxious behaviors and support adaptive child behaviors.
4 one hour parent sessions over 12 weeks in which the therapist supports the parent in understanding and implementing content reviewed in the book "Breaking Free of Child Anxiety and OCD".
Outcomes
Primary Outcome Measures
Pediatric Anxiety Rating Scale
Clinician-rated child anxiety severity throughout the past week. Each item is scored on a 0 to 5 scale (higher scores correspond to greater severity), yielding a total between 0 and 30.
Secondary Outcome Measures
Anxiety Disorders Interview Schedule (ADIS-IV) with Clinical Severity Ratings
Clinician-rated diagnostic interview that includes current anxiety disorders, depression, obsessive-compulsive disorder, and related disorders. Each diagnostic category is coded as present or absent based on symptom criteria and clinical severity ratings (CSRs), which indicate the level of clinical interference. CSRs are scored on a 0-8 scale (0 = not at all; 8 = very, very much). CSRs of 4 or above indicate the clinical levels.
Clinical Global Impression-Severity
Clinician-rated child psychopathology severity rating. A single item is scored 0-6 (0= no illness; 6= extremely severe symptoms).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04922502
Brief Title
Parent-based Treatment for Youth With Anxiety and Obsessive-compulsive Disorder
Official Title
Parent-based Treatment for Youth With Anxiety and Obsessive-compulsive Disorder: Comparison of Therapist-Led and Therapist Assisted Approaches
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Anxiety and obsessive-compulsive disorders are the most common mental health disorders in childhood and adolescence. A parenting intervention for youth with anxiety, called Supportive Parenting of Anxious Childhood Emotions ("SPACE"), has been recently developed to help target anxiety in children. In this intervention, therapists meet individually with parents to help them reduce anxiety behaviors in their children and support adaptive behaviors in their children. The purpose for the proposed study is to demonstrate the treatment efficacy of SPACE compared to a low-contact, therapist-supported bibliotherapy version of this intervention.
Detailed Description
Anxiety and obsessive-compulsive disorders are the most common mental health disorders in childhood and adolescence. Parental accommodation of their children's avoidance, escape, safety behaviors are a set of parenting behaviors that have been most strongly associated with child anxiety and obsessive-compulsive disorder. Developing and testing parent-led interventions that target accommodation and parenting styles associated with anxiety has the potential to improve treatment outcomes and reach families who may not otherwise access care (for example, for youth who refuse to attend therapy). A parenting intervention for youth with anxiety has been recently developed to address these goals called Supportive Parenting of Anxious Childhood Emotions ("SPACE"). In this intervention, therapists meet individually with parents to help them reduce accommodation and support adaptive behaviors in their children. SPACE was recently shown to be non-inferior to individual cognitive-behavioral therapy with 88% of youth being classified as responders to SPACE. The purpose for the proposed study is to demonstrate the treatment efficacy of SPACE compared to a low-contact, therapist-supported bibliotherapy version of this intervention, providing efficacy evidence for SPACE as delivered by an independent investigatory group.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-Compulsive Disorder in Children, Social Anxiety Disorder of Childhood, Obsessive-Compulsive Disorder in Adolescence, Separation Anxiety, Generalized Anxiety Disorder, Panic Disorder, Panic Attacks, Panic With Agoraphobia
Keywords
obsessive-compulsive disorder, children, cognitive behavioral therapy, anxiety
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Randomized assignment to one of two conditions
Masking
Outcomes Assessor
Masking Description
Outcomes assessor is blinded
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard SPACE
Arm Type
Active Comparator
Arm Description
12 one hour parent sessions over 12 weeks in which the therapist guides the parent to target anxious behaviors and support adaptive child behaviors.
Arm Title
Bibliotherapy, low therapist contact SPACE
Arm Type
Active Comparator
Arm Description
4 one hour parent sessions over 12 weeks in which the therapist supports the parent in understanding and implementing content reviewed in the book "Breaking Free of Child Anxiety and OCD".
Intervention Type
Behavioral
Intervention Name(s)
Standard SPACE
Intervention Description
12 one hour parent sessions over 12 weeks in which the therapist guides the parent to target anxious behaviors and support adaptive child behaviors.
Intervention Type
Behavioral
Intervention Name(s)
Bibliotherapy, low therapist contact SPACE
Intervention Description
4 one hour parent sessions over 12 weeks in which the therapist supports the parent in understanding and implementing content reviewed in the book "Breaking Free of Child Anxiety and OCD".
Primary Outcome Measure Information:
Title
Pediatric Anxiety Rating Scale
Description
Clinician-rated child anxiety severity throughout the past week. Each item is scored on a 0 to 5 scale (higher scores correspond to greater severity), yielding a total between 0 and 30.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Anxiety Disorders Interview Schedule (ADIS-IV) with Clinical Severity Ratings
Description
Clinician-rated diagnostic interview that includes current anxiety disorders, depression, obsessive-compulsive disorder, and related disorders. Each diagnostic category is coded as present or absent based on symptom criteria and clinical severity ratings (CSRs), which indicate the level of clinical interference. CSRs are scored on a 0-8 scale (0 = not at all; 8 = very, very much). CSRs of 4 or above indicate the clinical levels.
Time Frame
Up to 24 weeks
Title
Clinical Global Impression-Severity
Description
Clinician-rated child psychopathology severity rating. A single item is scored 0-6 (0= no illness; 6= extremely severe symptoms).
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
The child is between the ages of 7 to 17 at enrollment
The child has clinically significant symptoms of anxiety and/or OCD, as indicated by a score of 12 or higher on the Pediatric Anxiety Rating Scale (PARS).
The child is appropriate for anxiety-focused treatment (e.g., anxiety is the primary problem as diagnosed using the Anxiety Disorders Interview Schedule (ADIS), and if secondary psychopathology is present it will not interfere with treatment).
One parent/guardian is able and willing to participate in assessment and treatment (e.g., has sufficient English fluency, the decisional capacity to participate, and can commit to treatment duration).
The participating parent/guardian lives with their child at least 50% of the time.
Both parent and child are able to read and understand English.
The child is able to communicate verbally.
Participants must reside in Texas and parents must be in the state of Texas when taking calls.
Exclusion Criteria:
the child has a diagnosis of child lifetime bipolar disorder, drug of alcohol abuse, intellectual or developmental disability, psychotic disorder, or conduct disorder.
the child has severe, current suicidal/homicidal ideation and/or self-injury requiring medical intervention (referrals will be made for appropriate clinical intervention).
the child is receiving concurrent evidence-based psychotherapy for anxiety, involving exposure therapy in at least 50% of sessions.
the child has initiated or changed dosage of psychotropic medications within 4 weeks before study enrollment OR stimulant or benzodiazepine medications within 2 weeks before study enrollment. If appropriate, the child may be enrolled in the study once medication dosage has stabilized (i.e., 4 weeks for psychotropic medication or 2 weeks for stimulant/benzodiazepine medication).
Facility Information:
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30851397
Citation
Lebowitz ER, Marin C, Martino A, Shimshoni Y, Silverman WK. Parent-Based Treatment as Efficacious as Cognitive-Behavioral Therapy for Childhood Anxiety: A Randomized Noninferiority Study of Supportive Parenting for Anxious Childhood Emotions. J Am Acad Child Adolesc Psychiatry. 2020 Mar;59(3):362-372. doi: 10.1016/j.jaac.2019.02.014. Epub 2019 Mar 7.
Results Reference
result
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Parent-based Treatment for Youth With Anxiety and Obsessive-compulsive Disorder
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