Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04922502
Other study ID # H-49809
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
Start date July 1, 2021
Est. completion date December 22, 2023

Study information

Verified date February 2024
Source Baylor College of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 68
Est. completion date December 22, 2023
Est. primary completion date December 22, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 7 Years to 17 Years
Eligibility 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).

Study Design


Related Conditions & MeSH terms


Intervention

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.
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".

Locations

Country Name City State
United States Baylor College of Medicine Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
Baylor College of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 Ch — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 7 days
Secondary 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. Up to 24 weeks
Secondary Clinical Global Impression-Severity Clinician-rated child psychopathology severity rating. A single item is scored 0-6 (0= no illness; 6= extremely severe symptoms). 7 days
See also
  Status Clinical Trial Phase
Terminated NCT03420456 - Transcranial Pulse Near-Infrared Light in Generalized Anxiety Disorder: a Placebo-Controlled Study N/A
Active, not recruiting NCT05530642 - An Augmented Training Program for Preventing Post-Traumatic Stress Injuries Among Diverse Public Safety Personnel N/A
Withdrawn NCT02382224 - Worry Exposure for Generalized Anxiety Disorder N/A
Completed NCT02256566 - Cognitive Training for Mood and Anxiety Disorders N/A
Completed NCT02306356 - Internet-delivered Treatment for Children With Anxiety Disorders in a Rural Area; an Open Trial in a Clinical Setting N/A
Completed NCT01958788 - Testing Beliefs About Uncertainty in the Treatment of Generalized Anxiety Disorder N/A
Completed NCT01681329 - Cognitive-Behavioral Treatment and Interpretation Modification Training for Adults With Generalized Anxiety Disorder N/A
Completed NCT01337713 - Efficacy of Massage Therapy in the Treatment of Generalized Anxiety Disorder (GAD) N/A
Completed NCT01342120 - PHARMO Institute Seroquel Safety Study N/A
Completed NCT01201967 - A Collaborative Care Program to Improve Treatment of Depression and Anxiety Disorders in Cardiac Patients Phase 4
Completed NCT01203293 - Cognitive Behavioral Therapy (CBT) for Latinos With Generalized Anxiety Disorder in the General Medical Sector Phase 1
Completed NCT01971203 - Efficacy of Extended-release Quetiapine (Seroquel XR) as Adjunctive Therapy to Cognitive Behavioral Therapy in the Treat N/A
Completed NCT00961298 - An Open Label Trial of Duloxetine in the Treatment of Irritable Bowel Syndrome and Comorbid Generalized Anxiety Disorder Phase 4
Completed NCT00711737 - Study of the Changes in Metabolic Parameters in Patients Treated With Escitalopram for Six Months N/A
Terminated NCT01244711 - Open-Label Pilot Study to Examine the Value of Substituting Quetiapine for Benzodiazepines Phase 4
Completed NCT00744627 - Efficacy and Safety of Vortioxetine (Lu AA21004) for Treatment of Generalized Anxiety Disorder in Adults. Phase 3
Completed NCT00525226 - Evaluating the Effects of Stress in Pregnancy N/A
Completed NCT00515242 - Therapeutic Massage for Generalized Anxiety Disorder Phase 1/Phase 2
Completed NCT00537615 - An Open-label Study to Investigate the Absorption, Metabolism and Excretion of Radiolabeled PD 0332334 in Six Healthy Male Volunteers Phase 1
Completed NCT00368745 - Efficacy and Safety of Pregabalin vs Placebo for Generalized Anxiety Disorder (GAD) Symptoms in Subjects Discontinuing Benzodiazepine Treatment and Remaining 6 Weeks on Study Medication, Free From Benzodiazepine Use. Phase 3