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Anxiety Disorder of ChildhoodNCT03585010

Brain Response Associated With Parent-based Treatment for Childhood Anxiety Disorders

A study testing Supportive Parenting for Anxious Childhood Emotions, Parent Educational Support and Cognitive-Behavioral Therapy in people with Anxiety Disorder of Childhood and Separation Anxiety Disorder of Childhood, run by Yale University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study aims to investigate whether a parent-based treatment for childhood anxiety disorders engages child brain circuitry implicated in children's reliance on parents to reduce anxiety (R61), and whether change in child brain circuitry is associated with reduction in child anxiety (R33). Read more about this study

Who is it for?
Ages 6 to 12 yearsHealthy volunteers can take part
What is being tested?
Supportive Parenting for Anxious Childhood Emotions, Parent Educational Support and Cognitive-Behavioral Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
214 participants
Where
1 siteUnited States
Study dates
24 Aug 2018to 31 Mar 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 6 to 12 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Prepubertal
  • Clinical diagnosis of primary anxiety disorder
  • Must not have another mental illness more impairing than the most impairing anxiety disorder
  • IQ of at least 80.

Who cannot join

  • Neurological disorders (including seizures)
  • Organic mental disorders, psychotic disorders, or pervasive developmental disorders
  • High likelihood of hurting themselves or others
  • Current psychosocial or psychopharmacological treatment
  • History of neurological illness or head injury with loss of consciousness > 5 minutes
  • Vision or physical disability that interferes with seeing stimuli presented briefly on computer screen and/or clicking a mouse button rapidly and repeatedly
  • Contraindications for MRI scanning (e.g., metal implants, pacemakers, braces, claustrophobia, pregnancy, weight > 250 pounds).

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Yale University Child Study Center

    New Haven, Connecticut, 06519

Other trials in United States

About this study

This study aims to investigate whether a parent-based treatment for childhood anxiety disorders engages child brain circuitry implicated in children's reliance on parents to reduce anxiety (R61), and whether change in child brain circuitry is associated with reduction in child anxiety (R33).

Read the detailed description

Specific Aims: Anxiety disorders impact up to one-third of children, cause tremendous suffering, increase risk for psychiatric and medical morbidity, impair school and social functioning, and cost billions of dollars each year. Data consistently show that child anxiety is characterized by amygdala hyperactivity and deficits in prefrontal control of the amygdala. Emerging data link these disruptions to anxious children's over-reliance on parents for amygdala-medial prefrontal cortex (mPFC) engagement and anxiety reduction.

In the first phase of this study we aim to demonstrate that an entirely parent-based psychosocial treatment with no child involvement, Supportive Parenting for Anxious Childhood Emotions (SPACE), engages an amygdala-mPFC target in anxious children, lessening child reliance on parents to reduce amygdala reactivity.

Cross-species neurobiological evidence indicates that parental presence reduces amygdala reactivity and activates the mPFC to reduce offspring anxiety. In humans we recently demonstrated parental presence increases functional connectivity between their child's mPFC and amygdala, reducing the child's amygdala reactivity and anxiety. In a healthy sample, parental engagement of child amygdala-mPFC connectivity was linked to the child's reliance on parents for help with anxiety. Data from clinically anxious children likewise show parental presence engages child mPFC, and data we collected since our previous submission demonstrate that parental presence reduces amygdala reactivity in clinically anxious children.

Offspring's natural reliance on parents for anxiety reduction is magnified in clinically anxious children. Parents become deeply enmeshed in their child's symptoms through the process of family accommodation, defined as change in parents' behavior to help the child avoid or alleviate anxiety. In clinically anxious children, 90% report depending on parents to reduce their anxiety, and 97% of parents report accommodating their anxious child's symptoms. These cross-generational patterns of parental entanglement in their child's anxiety symptoms contribute to the immense burden, distress, and costs of pediatric anxiety (e.g., parents missing work to be with their anxious child). Anxious children's reliance on parents for anxiety reduction may disrupt the child's ability to independently reduce amygdala reactivity and anxiety.

We developed SPACE to translate these neurobiological and clinical research findings into a manualized parent-based treatment focused on reducing family accommodation in parents of anxious children. Preliminary data from a randomized clinical trial show that after 12 weeks of parents receiving SPACE (N=29), with no therapist-child contact, family accommodation and child anxiety were significantly reduced. We propose that SPACE engages anxious children's amygdala-mPFC circuitry, lessening their reliance on parents to reduce amygdala reactivity.

The first phase of the study will examine clinically anxious children's amygdala-mPFC response to fear faces when (A) the child's parent is beside them holding their hand during the fMRI scan (Parent-Present), and (B) the child is alone during the scan (Parent-Absent) (within-subjects design). Children with primary separation, social, or generalized anxiety disorder diagnoses, the most common childhood anxiety disorders, will serve as participants. Children will complete Parent-Present and Parent-Absent scans PRE- and POST-SPACE, or PRE- and POST-Parent Educational Support (PES), the comparator treatment that controls for treatment duration and therapist-parent contact. We expect SPACE will lessen child reliance on parental presence to engage amygdala-mPFC circuitry and reduce child amygdala reactivity. Aim 1: Demonstrate SPACE lessens children's reliance on parents to reduce amygdala reactivity (target engagement). Hyp 1: Child reliance on parental presence to reduce amygdala reactivity, (i.e., the difference between child amygdala reactivity in the Parent-Present and Parent-Absent scan), will decrease significantly from PRE- to POST-SPACE, as compared with PRE- to POST-PES. If Hyp 1 is confirmed we will proceed to the the second phase of the study.

The second phase of the study will be performed to re-demonstrate target engagement in SPACE, compared to cognitive-behavioral therapy (CBT); demonstrate target engagement is associated with symptom reduction in SPACE; and demonstrate SPACE's acceptability/feasibility. The second phase will enroll clinically anxious children (7-10 yrs), randomly assigned to SPACE or CBT. Aim 1: Re-demonstrate target engagement in SPACE. Hyp 1: Child reliance on parental presence to reduce amygdala reactivity will decrease significantly from PRE- to POST-SPACE, as compared with PRE- to POST-CBT. Aim 2: Demonstrate target engagement is associated with symptom reduction in SPACE. Hyp 2: Reduction in child anxiety from PRE- to POST-SPACE will be significantly associated with reduction in child reliance on parental presence to reduce amygdala reactivity. Aim 3: Establish acceptability and feasibility of SPACE. Hyp 3: SPACE will be acceptable and feasible to administer, and comparable to CBT. The second phase will also provide insight into the relative efficacy of SPACE, to inform future research and development of SPACE.

This study has the potential to provide groundbreaking results, with major public health impact, on how parent-based treatments can target disrupted neurobiological processes in children with psychopathology. These novel data will inform decision-making about a large-scale study (R01) to confirm the efficacy of SPACE and examine personalized treatment strategies.

Being tested
Supportive Parenting for Anxious Childhood Emotions, Parent Educational Support, Cognitive-Behavioral Therapy
Keywords
anxiety disorders
Medical subject headings
Generalized Anxiety Disorder, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Supportive Parenting for Anxious Childhood EmotionsBehavioural

    12 sessions with parents

  • Parent Educational SupportBehavioural

    12 sessions with parents

  • Cognitive-Behavioral TherapyBehavioural

    12 sessions with child

Study groups in NCT03585010
Study groupRoleWhat they receive
Supportive Parenting for Anxious Childhood Emotions (SPACE)ExperimentalParent-based treatment for childhood anxiety disorders, 12 sessions with parents.
Receives: Behavioral: Supportive Parenting for Anxious Childhood Emotions
Parent Educational Support (PES)Active comparatorParent Educational Support: 12 sessions with parents
Receives: Behavioral: Parent Educational Support
Cognitive Behavioral Therapy (CBT)Active comparatorCognitive-Behavioral Therapy: 12 sessions with child
Receives: Behavioral: Cognitive-Behavioral Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline Anxiety Severity on the Pediatric Anxiety Rating Scale (PARS) at Week 12.

    The PARS is a clinician-administered measure of anxiety severity in children and adolescents.

    Total scores on PARS are used as indicator of anxiety severity. Total scores range from 0-35, with higher scores indicating more severe anxiety.

    Measured: Baseline and 12 weeks

Secondary outcomes (1)
  1. Change From Baseline Anxiety Severity on the Multimodal Anxiety Scale for Children (MASC) at Week 12.

    The MASC is a self-report measure of anxiety severity, completed by children and parents separately.

    MASC generates a total anxiety score and several sub scales:

    Total scores: range from 0-150 Separation/Phobias scores: range from 0-27 Generalized anxiety scores: range from 0-30 Social anxiety scores: range from 0-27 Obsessive-compulsive symptom scores: 0-50 Physical symptoms scores: 0-60 For Total score and all sub-scales, higher scores indicate more severe anxiety. Data presented below are for the parent and child versions.

    Measured: Baseline and 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2018
  2. Study start24 Aug 2018
  3. Primary completion31 Mar 2024
  4. Study completion31 Mar 2024

Resources

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
214 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03585010
Sponsor's protocol ID
2000023649
Other IDs
4R33MH115113-03, 1R61MH115113-01A1
Status last verified
Apr 2026
First submitted
29 Jun 2018
Last updated
22 Apr 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Deidentified individual participant data for primary and secondary measures will be made available

Questions about this trial

What is this clinical trial studying?

A study testing Supportive Parenting for Anxious Childhood Emotions, Parent Educational Support and Cognitive-Behavioral Therapy in people with Anxiety Disorder of Childhood and Separation Anxiety Disorder of Childhood, 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 4 inclusion and 7 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 22 Apr 2026. 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?

Yes. Results are posted in the registry (first posted 22 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change From Baseline Anxiety Severity on the Pediatric Anxiety Rating Scale (PARS) at Week 12. (time frame: Baseline and 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 22 Apr 2026.

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