Anxiety DisordersSPACENCT02310152
Explanatory Clinical Trial of a Novel Parent Intervention for Childhood Anxiety (SPACE)
A study testing Parent-Based Treatment of Child and Adolescent Anxiety Disorders and CBT in people with Anxiety Disorders and Anxiety, Separation, run by Yale University at 1 site in United States.
Trial summary
Childhood anxiety disorders are very common, carry tremendous personal and societal costs, frequently do not respond adequately to treatment, and involving parents in treatment has so far not enhanced outcomes. Read more about this study
- Who is it for?
- Ages 7 to 14 years
- Conditions the study is for
- Anxiety Disorders, Anxiety, Separation, Phobic Disorders
- What is being tested?
- Parent-Based Treatment of Child and Adolescent Anxiety Disorders and CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children:
- meet criteria for a primary DSM5 anxiety disorder of generalized anxiety disorder (GAD), social phobia (SOP), and separation anxiety disorder (SAD) using the DSM-5 version of the Anxiety Disorders Interview Schedule -Child and Parent Versions (ADIS-C/P)
- mean score of 4 or greater on the ADIS-C/P Clinician Rating Scale of Severity (CSR)
- ceasing all other psychosocial treatment upon consultation with the clinic staff and the service provider
- not using any psychotropic medication other than a stable dose of stimulant medication treatment for comorbid ADHD or a stable dose of Selective Serotonin Reuptake Inhibitor (SSRI)
- children who are on a stable dose of stimulant medication or SSRI (i.e., a minimum of six weeks at the same dose) will be included so as not to limit generalizability.
Who cannot join
- Children:
- primary diagnosis of any Axis I DSM-IV disorder other than GAD, SOP, Phobias and SAD
- any of the following disorders (e.g., primary, secondary, tertiary) - Pervasive Developmental Disorders, Mental Retardation, Organic Mental Disorders, Bipolar Disorder, Schizophrenia and Other Psychotic Disorders
- drug or alcohol abuse/dependence will also be exclusionary
- tic disorders will not be exclusionary unless they require psychotropic medication to stabilize
- Significant active suicidal ideation or a past suicide attempt in the last 6 months. Adolescents with a history of non-lethal self-harm behaviors (e.g., cutting) will be allowed to enroll if they meet other criteria
Show all 12Show fewer
- have an intellectual disability as reported by guardian
- be a victim of past or present undisclosed abuse requiring investigation or ongoing supervision by the Department of Social Services
- not have been cohabiting with mother for at least one year prior to admittance. Parent:
- any of the following disorders (e.g., primary, secondary, tertiary) - Pervasive Developmental Disorders, Mental Retardation, Selective Mutism, Organic Mental Disorders, Bipolar Disorder, Schizophrenia and Other Psychotic Disorders. Drug or alcohol abuse/dependence will also be exclusionary
- not have been cohabiting with child for at least one year prior to admittance
- report the presence of any active suicidal ideation or a past suicide attempt in the last 6 months.
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale University Child Study Center
New Haven, Connecticut, 06519
About this study
Childhood anxiety disorders are very common, carry tremendous personal and societal costs, frequently do not respond adequately to treatment, and involving parents in treatment has so far not enhanced outcomes. Explanatory clinical trials are needed to identify parent specific mechanisms of change that are not targeted in direct child treatment, and to identify markers of who is most likely to benefit from parent intervention. This study is an explanatory clinical trial of a parent based intervention and of cognitive behavioral therapy, and an investigation of biological and behavioral moderators of treatment response.
Read the detailed description
Despite strong evidence for the efficacy of individual cognitive-behavior therapy (ICBT) for childhood anxiety disorders, up to 50% of children remain symptomatic after treatment and many still meet diagnostic criteria. Evidence for parental influences in the etiology and maintenance of anxiety in children has often led to the reasonable assumption that adding parent work to ICBT would enhance treatment effects. This idea has now been repeatedly tested in randomized controlled trials (RCTs) that compared ICBT to ICBT with added parent work. The specific content of the parent work has varied but has mainly included teaching parents skills for contingency management, modeling appropriate behavior, and reducing family conflict. Working with parents in these ways has so far not led to enhanced treatment effects compared to ICBT alone, as a number of meta-analytic and comprehensive reviews have shown.
One plausible conclusion from these data is that parent work cannot enhance effects beyond what is achieved through ICBT alone. This study focuses on an alternative plausible conclusion: That parent interventions need to be informed by theoretical working models of parent-specific mechanisms of change that are not targeted in ICBT; and that parent interventions need to be evaluated in explanatory RCTs that ask not only 'does treatment work?' but also 'how and for whom does treatment work?' Underlying systems that shape how parents respond to child anxiety or distress can provide clues to parent-specific targets for intervention and can point to potential moderators of treatment response. Identifying mechanisms by which parent interventions can enhance child anxiety outcomes, and identifying markers of parents most in need of such interventions advances the goal of personalized psychotherapy, and is the overall goal of this study.
Family accommodation (FA) describes parents' attempts to help a child avoid feeling anxious by participating in symptom-driven behaviors and modifying family routines. FA is highly prevalent among parents of anxious children and has been linked to greater symptom severity in the child and to poorer response to ICBT. Research has linked a number of biological and behavioral parent markers to protective parental behavior and to child anxiety. The nonapeptide oxytocin (OT) is implicated in parental attachment and protective behavior in humans and animals. Coded behavioral observations link aspects of parental behavior (i.e., autonomy granting, over involvement, and sensitivity) to child anxiety. A number of studies also have shown that these biological and behavioral markers interact to predict anxiety outcomes in at-risk children. Yet so far this research has been siloed from intervention research and has not informed parent-based treatments, highlighting the need for clinical investigators equipped with the necessary skills to integrate multiple units of analysis into explanatory RCTs of novel interventions.
This study represents a fusion of clinical, biological and behavioral research through an explanatory RCT of a parent-based treatment focused on modifying parental responses to child anxiety and distress as a mediator of treatment outcome, and on biological and behavioral markers as possible moderators of treatment outcome. The intervention evaluated in this study (Supportive Parenting for Anxious Childhood Emotions; SPACE) aims to systematically reduce FA through a series of concrete manualized steps. This study is an integrated explanatory RCT of SPACE with the following 3 specific aims:
Aim 1 - Specificity: Does SPACE lead to significantly lower levels of FA compared to ICBT? Hypothesis: Levels of FA for parents in SPACE will be significantly lower after treatment than before treatment, as compared to parents of children in ICBT.
Aim 2 - Mediation: Does reducing FA lead to positive child outcomes? Hypothesis: Parents' reduced FA will be a significant mediator of positive child outcomes (i.e., reduced child anxiety).
Aim 3 - Moderation: Do key biological and behavioral markers (i.e., parental OT, autonomy granting, over involvement, sensitivity) moderate child outcomes? Hypothesis: Baseline levels of maternal OT, autonomy granting, over involvement, and sensitivity will be significant moderators of child outcomes (i.e., reducing child anxiety).
- Conditions
- Anxiety Disorders, Anxiety, Separation, Phobic Disorders
- Being tested
- Parent-Based Treatment of Child and Adolescent Anxiety Disorders, CBT
- Keywords
- Child, Adolescent, Parents, Cognitive Therapy, Cognitive Behavior Therapy, Anxiety
- Medical subject headings
- Anxiety Disorders, Anxiety, Separation, Phobic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent-Based Treatment of Child and Adolescent Anxiety DisordersBehavioural
Also called SPACE
Supportive Parenting for Anxious Childhood Emotions
CBTBehavioural
Cognitive Behavioral Therapy
| Study group | Role | What they receive |
|---|---|---|
| Active Treatment: CBT | Active comparator | Cognitive Behavioral Therapy Receives: Behavioral: CBT |
| Experimental Treatment: SPACE | Experimental | Parent-Based Treatment of Childhood and Adolescent Anxiety Disorders Receives: Behavioral: Parent-Based Treatment of Child and Adolescent Anxiety Disorders |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Global Impression Scale Improvement and Severity
Clinician determined rating of illness
Measured: After 12 weeks of treatment
Pediatric Anxiety Rating Scale
Clinician administered rating of child anxiety
Measured: After 12 weeks of treatment
Secondary outcomes (1)
Screen for Childhood Anxiety Related Disorders
A self and parent report of child anxiety
Measured: After 12 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2014 (estimated)
- Study startNov 2014
- Primary completionNov 2018
- Study completionNov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02310152
- Sponsor's protocol ID
- 1311013020
- Other IDs
- 5K23MH103555-03
- Acronym
- SPACE
- Status last verified
- Mar 2020
- First submitted
- 3 Dec 2014
- Last updated
- 9 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Lebowitz, E. R., Omer, H., Hermes, H., & Scahill, L. (2013). Parent Training for Childhood Anxiety Disorders: The SPACE Program. Cognitive and Behavioral Practice.
Lebowitz ER, Woolston J, Bar-Haim Y, Calvocoressi L, Dauser C, Warnick E, Scahill L, Chakir AR, Shechner T, Hermes H, Vitulano LA, King RA, Leckman JF. Family accommodation in pediatric anxiety disorders. Depress Anxiety. 2013 Jan;30(1):47-54. doi: 10.1002/da.21998. Epub 2012 Sep 10.
PubMed 22965863Lebowitz 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 Child Adolesc Psychiatry. 2020 Mar;59(3):362-372. doi: 10.1016/j.jaac.2019.02.014. Epub 2019 Mar 7.
PubMed 30851397
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Explanatory Clinical Trial of a Novel Parent Intervention for Childhood Anxiety (SPACE)
- ClinicalTrials.gov ID
- NCT02310152
- Acronym / sponsor ID
- SPACE / 1311013020
- Conditions
- Anxiety Disorders, Anxiety, Separation, Phobic Disorders
- Keywords
- Child, Adolescent, Parents, Cognitive Therapy, Cognitive Behavior Therapy, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Nov 2014
- Primary completion
- Nov 2018 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 5 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Childhood anxiety disorders are very common, carry tremendous personal and societal costs, frequently do not respond adequately to treatment, and involving parents in treatment has so far not enhanced outcomes. Explanatory clinical trials are needed to identify parent specific mechanisms of change that are not targeted in direct child treatment, and to identify markers of who is most likely to benefit from parent intervention. This study is an explanatory clinical trial of a parent based intervention and of cognitive behavioral therapy, and an investigation of biological and behavioral moderators of treatment response.
Detailed description
Despite strong evidence for the efficacy of individual cognitive-behavior therapy (ICBT) for childhood anxiety disorders, up to 50% of children remain symptomatic after treatment and many still meet diagnostic criteria. Evidence for parental influences in the etiology and maintenance of anxiety in children has often led to the reasonable assumption that adding parent work to ICBT would enhance treatment effects. This idea has now been repeatedly tested in randomized controlled trials (RCTs) that compared ICBT to ICBT with added parent work. The specific content of the parent work has varied but has mainly included teaching parents skills for contingency management, modeling appropriate behavior, and reducing family conflict. Working with parents in these ways has so far not led to enhanced treatment effects compared to ICBT alone, as a number of meta-analytic and comprehensive reviews have shown.
One plausible conclusion from these data is that parent work cannot enhance effects beyond what is achieved through ICBT alone. This study focuses on an alternative plausible conclusion: That parent interventions need to be informed by theoretical working models of parent-specific mechanisms of change that are not targeted in ICBT; and that parent interventions need to be evaluated in explanatory RCTs that ask not only 'does treatment work?' but also 'how and for whom does treatment work?' Underlying systems that shape how parents respond to child anxiety or distress can provide clues to parent-specific targets for intervention and can point to potential moderators of treatment response. Identifying mechanisms by which parent interventions can enhance child anxiety outcomes, and identifying markers of parents most in need of such interventions advances the goal of personalized psychotherapy, and is the overall goal of this study.
Family accommodation (FA) describes parents' attempts to help a child avoid feeling anxious by participating in symptom-driven behaviors and modifying family routines. FA is highly prevalent among parents of anxious children and has been linked to greater symptom severity in the child and to poorer response to ICBT. Research has linked a number of biological and behavioral parent markers to protective parental behavior and to child anxiety. The nonapeptide oxytocin (OT) is implicated in parental attachment and protective behavior in humans and animals. Coded behavioral observations link aspects of parental behavior (i.e., autonomy granting, over involvement, and sensitivity) to child anxiety. A number of studies also have shown that these biological and behavioral markers interact to predict anxiety outcomes in at-risk children. Yet so far this research has been siloed from intervention research and has not informed parent-based treatments, highlighting the need for clinical investigators equipped with the necessary skills to integrate multiple units of analysis into explanatory RCTs of novel interventions.
This study represents a fusion of clinical, biological and behavioral research through an explanatory RCT of a parent-based treatment focused on modifying parental responses to child anxiety and distress as a mediator of treatment outcome, and on biological and behavioral markers as possible moderators of treatment outcome. The intervention evaluated in this study (Supportive Parenting for Anxious Childhood Emotions; SPACE) aims to systematically reduce FA through a series of concrete manualized steps. This study is an integrated explanatory RCT of SPACE with the following 3 specific aims:
Aim 1 - Specificity: Does SPACE lead to significantly lower levels of FA compared to ICBT? Hypothesis: Levels of FA for parents in SPACE will be significantly lower after treatment than before treatment, as compared to parents of children in ICBT.
Aim 2 - Mediation: Does reducing FA lead to positive child outcomes? Hypothesis: Parents' reduced FA will be a significant mediator of positive child outcomes (i.e., reduced child anxiety).
Aim 3 - Moderation: Do key biological and behavioral markers (i.e., parental OT, autonomy granting, over involvement, sensitivity) moderate child outcomes? Hypothesis: Baseline levels of maternal OT, autonomy granting, over involvement, and sensitivity will be significant moderators of child outcomes (i.e., reducing child anxiety).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Treatment: CBT | Active comparator | Behavioral: CBTCognitive Behavioral Therapy |
| Experimental Treatment: SPACE | Experimental | Behavioral: Parent-Based Treatment of Child and Adolescent Anxiety DisordersParent-Based Treatment of Childhood and Adolescent Anxiety Disorders |
Who may qualify
- Ages
- 7 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- meet criteria for a primary DSM5 anxiety disorder of generalized anxiety disorder (GAD), social phobia (SOP), and separation anxiety disorder (SAD) using the DSM-5 version of the Anxiety Disorders Interview Schedule -Child and Parent Versions (ADIS-C/P)
- mean score of 4 or greater on the ADIS-C/P Clinician Rating Scale of Severity (CSR)
- ceasing all other psychosocial treatment upon consultation with the clinic staff and the service provider
- not using any psychotropic medication other than a stable dose of stimulant medication treatment for comorbid ADHD or a stable dose of Selective Serotonin Reuptake Inhibitor (SSRI)
- children who are on a stable dose of stimulant medication or SSRI (i.e., a minimum of six weeks at the same dose) will be included so as not to limit generalizability.
Key exclusion criteria (12 listed)
- primary diagnosis of any Axis I DSM-IV disorder other than GAD, SOP, Phobias and SAD
- any of the following disorders (e.g., primary, secondary, tertiary) - Pervasive Developmental Disorders, Mental Retardation, Organic Mental Disorders, Bipolar Disorder, Schizophrenia and Other Psychotic Disorders
- drug or alcohol abuse/dependence will also be exclusionary
- tic disorders will not be exclusionary unless they require psychotropic medication to stabilize
- Significant active suicidal ideation or a past suicide attempt in the last 6 months. Adolescents with a history of non-lethal self-harm behaviors (e.g., cutting) will be allowed to enroll if they meet other criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parent-Based Treatment of Child and Adolescent Anxiety DisordersAlso: SPACESupportive Parenting for Anxious Childhood Emotions | Behavioural | Experimental Treatment: SPACE |
| CBTCognitive Behavioral Therapy | Behavioural | Active Treatment: CBT |
Primary outcome
Clinical Global Impression Scale Improvement and Severity
Time frame: After 12 weeks of treatment
Clinician determined rating of illness
Pediatric Anxiety Rating Scale
Time frame: After 12 weeks of treatment
Clinician administered rating of child anxiety
1 secondary outcome
Screen for Childhood Anxiety Related Disorders
Time frame: After 12 weeks of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2020.
- BackgroundLebowitz, E. R., Omer, H., Hermes, H., & Scahill, L. (2013). Parent Training for Childhood Anxiety Disorders: The SPACE Program. Cognitive and Behavioral Practice.
- Background: PubMed 22965863Lebowitz ER, Woolston J, Bar-Haim Y, Calvocoressi L, Dauser C, Warnick E, Scahill L, Chakir AR, Shechner T, Hermes H, Vitulano LA, King RA, Leckman JF. Family accommodation in pediatric anxiety disorders. Depress Anxiety. 2013 Jan;30(1):47-54. doi: 10.1002/da.21998. Epub 2012 Sep 10.
- Derived from this study: PubMed 30851397Lebowitz 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 Child Adolesc Psychiatry. 2020 Mar;59(3):362-372. doi: 10.1016/j.jaac.2019.02.014. Epub 2019 Mar 7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parent-Based Treatment of Child and Adolescent Anxiety Disorders and CBT in people with Anxiety Disorders and Anxiety, Separation, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Global Impression Scale Improvement and Severity (time frame: After 12 weeks of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02310152, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2020.