Trial Outcomes & Findings for Brain Response Associated With Parent-based Treatment for Childhood Anxiety Disorders (NCT NCT03585010)
NCT ID: NCT03585010
Last Updated: 2026-04-22
Results Overview
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.
COMPLETED
NA
214 participants
Baseline and 12 weeks
2026-04-22
Participant Flow
Participants were recruited based on physician or self-referral at Yale Child Study Center between August 2018 and October 2023. In Phase 1, the first participant was enrolled August 2018, and the last participant was enrolled in February 2020. In Phase 2, the first participant was enrolled on September 2020, and the last participant was enrolled in October 2023.
Of 104 participants enrolled in Phase 1, 78 met inclusion criteria and were randomized to treatment; 26 were excluded (11 did not meet criteria, 6 could not complete scan, and 9 dropped before randomization). Of 205 participants enrolled in Phase 2, 136 met inclusion criteria and were randomized to treatment; 69 were excluded (27 did not meet criteria, 26 did not complete scan, 14 dropped out before randomization, and 2 did not complete assessment.)
Participant milestones
| Measure |
Phase 1: Supportive Parenting for Anxious Childhood Emotions (SPACE)
Parent-based treatment for childhood anxiety disorders, 12 sessions with parents.
|
Phase 1: Parent Educational Support (PES)
Parent Educational Support: 12 sessions with parents
|
Phase 2: Supportive Parenting for Anxious Childhood Emotions (SPACE)
Parent-based treatment for childhood anxiety disorders, 12 sessions with parents.
|
Phase 2: Cognitive Behavioral Therapy (CBT)
Cognitive-Behavioral Therapy: 12 sessions with child
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
41
|
37
|
72
|
64
|
|
Overall Study
COMPLETED
|
39
|
33
|
62
|
57
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
10
|
7
|
Reasons for withdrawal
| Measure |
Phase 1: Supportive Parenting for Anxious Childhood Emotions (SPACE)
Parent-based treatment for childhood anxiety disorders, 12 sessions with parents.
|
Phase 1: Parent Educational Support (PES)
Parent Educational Support: 12 sessions with parents
|
Phase 2: Supportive Parenting for Anxious Childhood Emotions (SPACE)
Parent-based treatment for childhood anxiety disorders, 12 sessions with parents.
|
Phase 2: Cognitive Behavioral Therapy (CBT)
Cognitive-Behavioral Therapy: 12 sessions with child
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
4
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
6
|
5
|
Baseline Characteristics
Brain Response Associated With Parent-based Treatment for Childhood Anxiety Disorders
Baseline characteristics by cohort
| Measure |
Phase 1: Supportive Parenting for Anxious Childhood Emotions (SPACE)
n=39 Participants
Parent-based treatment for childhood anxiety disorders, 12 sessions with parents.
|
Phase 1: Parent Educational Support (PES)
n=33 Participants
Parent Educational Support: 12 sessions with parents
|
Phase 2: Supportive Parenting for Anxious Childhood Emotions (SPACE)
n=62 Participants
Parent-based treatment for childhood anxiety disorders, 12 sessions with parents.
|
Phase 2: Cognitive Behavioral Therapy (CBT)
n=57 Participants
Cognitive-Behavioral Therapy: 12 sessions with child
|
Total
n=191 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
8.33 years
STANDARD_DEVIATION 2.09 • n=60 Participants
|
8.36 years
STANDARD_DEVIATION 1.54 • n=56 Participants
|
8.27 years
STANDARD_DEVIATION 1.57 • n=116 Participants
|
8.44 years
STANDARD_DEVIATION 1.75 • n=7 Participants
|
8.35 years
STANDARD_DEVIATION 1.73 • n=3 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=60 Participants
|
12 Participants
n=56 Participants
|
29 Participants
n=116 Participants
|
33 Participants
n=7 Participants
|
89 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=60 Participants
|
21 Participants
n=56 Participants
|
33 Participants
n=116 Participants
|
24 Participants
n=7 Participants
|
102 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=60 Participants
|
4 Participants
n=56 Participants
|
11 Participants
n=116 Participants
|
8 Participants
n=7 Participants
|
27 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
33 Participants
n=60 Participants
|
29 Participants
n=56 Participants
|
51 Participants
n=116 Participants
|
49 Participants
n=7 Participants
|
162 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=60 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=3 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=60 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=60 Participants
|
1 Participants
n=56 Participants
|
3 Participants
n=116 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=60 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=60 Participants
|
2 Participants
n=56 Participants
|
1 Participants
n=116 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=3 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=60 Participants
|
26 Participants
n=56 Participants
|
48 Participants
n=116 Participants
|
49 Participants
n=7 Participants
|
153 Participants
n=3 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=60 Participants
|
4 Participants
n=56 Participants
|
9 Participants
n=116 Participants
|
4 Participants
n=7 Participants
|
21 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=60 Participants
|
0 Participants
n=56 Participants
|
1 Participants
n=116 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=3 Participants
|
|
Region of Enrollment
United States
|
39 participants
n=60 Participants
|
33 participants
n=56 Participants
|
62 participants
n=116 Participants
|
57 participants
n=7 Participants
|
191 participants
n=3 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12 weeksPopulation: All participants for whom anxiety severity was recorded at Baseline and 12 weeks.
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.
Outcome measures
| Measure |
Phase 1: Supportive Parenting for Anxious Childhood Emotions (SPACE)
n=39 Participants
Parent-based treatment for childhood anxiety disorders, 12 sessions with parents.
|
Phase 1: Parent Educational Support (PES)
n=33 Participants
Parent Educational Support: 12 sessions with parents
|
Phase 2: Supportive Parenting for Anxious Childhood Emotions (SPACE)
n=62 Participants
Parent-based treatment for childhood anxiety disorders, 12 sessions with parents.
|
Phase 2: Cognitive Behavioral Therapy (CBT)
n=57 Participants
Cognitive-Behavioral Therapy: 12 sessions with child
|
|---|---|---|---|---|
|
Change From Baseline Anxiety Severity on the Pediatric Anxiety Rating Scale (PARS) at Week 12.
|
-11.82 score on a scale
Standard Deviation 7.45
|
-6.29 score on a scale
Standard Deviation 6.51
|
-8.47 score on a scale
Standard Deviation 6.52
|
-6.54 score on a scale
Standard Deviation 5.68
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: All participants for whom anxiety severity was recorded at Baseline and 12 weeks.
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.
Outcome measures
| Measure |
Phase 1: Supportive Parenting for Anxious Childhood Emotions (SPACE)
n=39 Participants
Parent-based treatment for childhood anxiety disorders, 12 sessions with parents.
|
Phase 1: Parent Educational Support (PES)
n=33 Participants
Parent Educational Support: 12 sessions with parents
|
Phase 2: Supportive Parenting for Anxious Childhood Emotions (SPACE)
n=62 Participants
Parent-based treatment for childhood anxiety disorders, 12 sessions with parents.
|
Phase 2: Cognitive Behavioral Therapy (CBT)
n=57 Participants
Cognitive-Behavioral Therapy: 12 sessions with child
|
|---|---|---|---|---|
|
Change From Baseline Anxiety Severity on the Multimodal Anxiety Scale for Children (MASC) at Week 12.
MASC-Child
|
-21.79 score on a scale
Standard Deviation 20.41
|
-24.61 score on a scale
Standard Deviation 27.31
|
-22.55 score on a scale
Standard Deviation 27.86
|
-26.09 score on a scale
Standard Deviation 26.06
|
|
Change From Baseline Anxiety Severity on the Multimodal Anxiety Scale for Children (MASC) at Week 12.
MASC-Parent
|
-17.17 score on a scale
Standard Deviation 18.48
|
-9.52 score on a scale
Standard Deviation 21.38
|
-14.69 score on a scale
Standard Deviation 15.83
|
-9.83 score on a scale
Standard Deviation 16.09
|
Adverse Events
Supportive Parenting for Anxious Childhood Emotions (SPACE)
Parent Educational Support (PES)
Cognitive Behavioral Therapy (CBT)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place