Parent-based Treatment for Youth With Anxiety and Obsessive-compulsive Disorder
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ClinicalTrials.gov Identifier: NCT04922502 |
Recruitment Status :
Completed
First Posted : June 10, 2021
Last Update Posted : February 14, 2024
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Condition or disease | Intervention/treatment | Phase |
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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 | Behavioral: Standard SPACE Behavioral: Bibliotherapy, low therapist contact SPACE | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 68 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Randomized assignment to one of two conditions |
Masking: | Single (Outcomes Assessor) |
Masking Description: | Outcomes assessor is blinded |
Primary Purpose: | Treatment |
Official Title: | Parent-based Treatment for Youth With Anxiety and Obsessive-compulsive Disorder: Comparison of Therapist-Led and Therapist Assisted Approaches |
Actual Study Start Date : | July 1, 2021 |
Actual Primary Completion Date : | December 22, 2023 |
Actual Study Completion Date : | December 22, 2023 |
Arm | Intervention/treatment |
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Active Comparator: Standard SPACE
12 one hour parent sessions over 12 weeks in which the therapist guides the parent to target anxious behaviors and support adaptive child behaviors.
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Behavioral: Standard SPACE
12 one hour parent sessions over 12 weeks in which the therapist guides the parent to target anxious behaviors and support adaptive child behaviors. |
Active Comparator: Bibliotherapy, low therapist contact SPACE
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".
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Behavioral: Bibliotherapy, low therapist contact SPACE
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". |
- Pediatric Anxiety Rating Scale [ Time Frame: 7 days ]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.
- Anxiety Disorders Interview Schedule (ADIS-IV) with Clinical Severity Ratings [ Time Frame: Up to 24 weeks ]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 [ Time Frame: 7 days ]Clinician-rated child psychopathology severity rating. A single item is scored 0-6 (0= no illness; 6= extremely severe symptoms).
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Ages Eligible for Study: | 7 Years to 17 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04922502
United States, Texas | |
Baylor College of Medicine | |
Houston, Texas, United States, 77030 |
Responsible Party: | Eric A Storch, Professor, Baylor College of Medicine |
ClinicalTrials.gov Identifier: | NCT04922502 |
Other Study ID Numbers: |
H-49809 |
First Posted: | June 10, 2021 Key Record Dates |
Last Update Posted: | February 14, 2024 |
Last Verified: | February 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
obsessive-compulsive disorder children cognitive behavioral therapy anxiety |
Anxiety Disorders Compulsive Personality Disorder Obsessive-Compulsive Disorder Panic Disorder Phobia, Social Agoraphobia |
Anxiety, Separation Mental Disorders Personality Disorders Phobic Disorders Neurodevelopmental Disorders |