Generalized Anxiety Disorder, Obsessive-Compulsive Disorder in Adolescence, Obsessive-Compulsive Disorder in Children, Panic Attacks, Panic Disorder, Panic With Agoraphobia, Separation Anxiety, Social Anxiety Disorder of Childhood
Conditions
Keywords
obsessive-compulsive disorder, children, cognitive behavioral therapy, anxiety
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.
Interventions
BEHAVIORALStandard 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.
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.
Sponsors
Baylor College of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcomes assessor is blinded
Intervention model description
Randomized assignment to one of two conditions
Eligibility
Sex/Gender
ALL
Age
7 Years to 17 Years
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pediatric Anxiety Rating Scale | Baseline (before treatment), post-treatment assessment (on average 12 weeks), one month follow up; Baseline scores reported. | 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 35. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety Disorders Interview Schedule (ADIS-IV) With Clinical Severity Ratings | 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 | Baseline (before treatment), post-treatment assessment (on average 12 weeks), one month follow up; Baseline scores reported. | Clinician-rated child psychopathology severity rating. A single item is scored 0-6 (0= no illness; 6= extremely severe symptoms). |
Countries
United States
Participant flow
Pre-assignment details
Enrollment numbers reflect both parent and child of the parent-child dyads.
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 33 |
| 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.
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. | 35 |
| Total | 68 |
Baseline characteristics
| Characteristic | Bibliotherapy, Low Therapist Contact SPACE | Standard SPACE | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 35 Participants | 33 Participants | 68 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 10.2 years STANDARD_DEVIATION 2.8 | 10.2 years STANDARD_DEVIATION 2.6 | 10.2 years STANDARD_DEVIATION 2.7 |
| Clinical Global Impressions Scale-Severity | 3.54 units on a scale STANDARD_DEVIATION 0.82 | 3.48 units on a scale STANDARD_DEVIATION 0.67 | 3.51 units on a scale STANDARD_DEVIATION 0.74 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 11 Participants | 10 Participants | 21 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants | 23 Participants | 47 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Pediatric Anxiety Rating Scale-Revised | 16.51 units on a scale STANDARD_DEVIATION 4.14 | 17.63 units on a scale STANDARD_DEVIATION 2.67 | 17.06 units on a scale STANDARD_DEVIATION 3.52 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 5 Participants | 9 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 6 Participants | 6 Participants | 12 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) White | 21 Participants | 21 Participants | 42 Participants |
| Region of Enrollment United States | 35 participants | 33 participants | 68 participants |
| Sex: Female, Male Female | 18 Participants | 15 Participants | 33 Participants |
| Sex: Female, Male Male | 17 Participants | 18 Participants | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 33 | 0 / 35 |
| other Total, other adverse events | 0 / 33 | 0 / 35 |
| serious Total, serious adverse events | 0 / 33 | 0 / 35 |
Outcome results
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 35.
Time frame: Baseline (before treatment), post-treatment assessment (on average 12 weeks), one month follow up; Baseline scores reported.
Population: Three participants did not complete the standard SPACE intervention, and 4 participants did not complete the low-therapist contact SPACE intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard SPACE | Pediatric Anxiety Rating Scale | 10.86 score on a scale | Standard Deviation 4.8 |
| Bibliotherapy, Low Therapist Contact SPACE | Pediatric Anxiety Rating Scale | 10.96 score on a scale | Standard Deviation 6.08 |
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.
Time frame: 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).
Time frame: Baseline (before treatment), post-treatment assessment (on average 12 weeks), one month follow up; Baseline scores reported.
Population: three participants did not complete the standard SPACE intervention and 4 participants did not complete the low-therapist contact SPACE intervention. Data for baseline scores reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard SPACE | Clinical Global Impression-Severity | 2.42 score on a scale | Standard Deviation 0.89 |
| Bibliotherapy, Low Therapist Contact SPACE | Clinical Global Impression-Severity | 2.52 score on a scale | Standard Deviation 0.93 |