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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard SPACE | Active Comparator | 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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| Bibliotherapy, low therapist contact SPACE | Active Comparator | 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard SPACE | Behavioral | 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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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (before treatment), post-treatment assessment (on average 12 weeks), one month follow up; Baseline scores reported. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38154287 | Result | Storch EA, Guzick AG, Ayton DM, Palo AD, Kook M, Candelari AE, Maye CE, McNeel M, Trent ES, Garcia JL, Onyeka OC, Rast CE, Shimshoni Y, Lebowitz ER, Goodman WK. Randomized trial comparing standard versus light intensity parent training for anxious youth. Behav Res Ther. 2024 Feb;173:104451. doi: 10.1016/j.brat.2023.104451. Epub 2023 Dec 17. |
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Enrollment numbers reflect both parent and child of the parent-child dyads.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Dec 20, 2023 |
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Randomized assignment to one of two conditions
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Outcomes assessor is blinded
| Bibliotherapy, low therapist contact SPACE | Behavioral | 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". |
|
| Up to 24 weeks |
| Clinical Global Impression-Severity | Clinician-rated child psychopathology severity rating. A single item is scored 0-6 (0= no illness; 6= extremely severe symptoms). | Baseline (before treatment), post-treatment assessment (on average 12 weeks), one month follow up; Baseline scores reported. |
| 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". |
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| COMPLETED |
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| NOT COMPLETED |
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Baseline Characteristics were not collected for Parents and only reflect the Child.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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". |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Clinical Global Impressions Scale-Severity | 7 point scale ranging from 0 (no illness) to 6 (most severe patient seen) | Mean | Standard Deviation | units on a scale |
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| Pediatric Anxiety Rating Scale-Revised | The Pediatric Anxiety Rating Scale-Revised (PARS) includes a 59-item symptom checklist and 7-item severity scale with parent and clinician-rated scores with range from 0 to 35. Higher scores indicate higher symptom severity. | Mean | Standard Deviation | units on a scale |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Three participants did not complete the standard SPACE intervention, and 4 participants did not complete the low-therapist contact SPACE intervention | Posted | Mean | Standard Deviation | score on a scale | Baseline (before treatment), post-treatment assessment (on average 12 weeks), one month follow up; Baseline scores reported. |
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| 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. | Not Posted | Up to 24 weeks | Participants | ||||||||||||||||||||||||||||||||||
| 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). | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline (before treatment), post-treatment assessment (on average 12 weeks), one month follow up; Baseline scores reported. |
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Participants were assessed up to 16 weeks. Non-responders to bibliotherapy had the option to participate in standard SPACE, and were possibly followed for an additional 8 weeks (for a total of 24 weeks). Adverse event data were collected for child participants only and were collected for the duration of a participant's involvement in the study.
The definition of an adverse event does not differ from that used on clinicaltrials.gov
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 33 | 0 | 33 | 0 | 33 |
| EG001 | 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". | 0 | 35 | 0 | 35 | 0 | 35 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Eric Storch | Baylor College of Medicine | (713) 798-3579 | eric.storch@bcm.edu |
| Aug 27, 2024 |
| Prot_SAP_ICF_000.pdf |
| ID | Term |
|---|---|
| D001010 | Anxiety, Separation |
| D000098647 | Generalized Anxiety Disorder |
| D016584 | Panic Disorder |
| D009771 | Obsessive-Compulsive Disorder |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D065886 | Neurodevelopmental Disorders |
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| ID | Term |
|---|---|
| D001638 | Bibliotherapy |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Units | Counts |
|---|---|
| Participants |
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