N/A
N=136
Parent-based Treatment for Youth With Anxiety and Obsessive-compulsive Disorder
Obsessive-Compulsive Disorder in Children · Social Anxiety Disorder of Childhood · Obsessive-Compulsive Disorder in Adolescence · Separation Anxiety · Generalized Anxiety Disorder
Bottom Line
View on ClinicalTrials.gov: NCT04922502 ↗Enrolled (actual)
136
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: Pediatric Anxiety Rating Scale — 10.86; 10.96 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Standard SPACE (Behavioral); Bibliotherapy, low therapist contact SPACE (Behavioral)
- Age
- Pediatric · 7+ yrs
- Sex
- All
- Sponsor
- Baylor College of Medicine
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pediatric Anxiety Rating Scale |
10.86; 10.96 | — |
| SECONDARY Anxiety Disorders Interview Schedule (ADIS-IV) With Clinical Severity Ratings |
— | — |
| SECONDARY Clinical Global Impression-Severity |
2.42; 2.52 | — |
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.
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).
Data sourced from ClinicalTrials.gov (NCT04922502). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.