Trial Outcomes & Findings for Parent-based Treatment for Youth With Anxiety and Obsessive-compulsive Disorder (NCT NCT04922502)
NCT ID: NCT04922502
Last Updated: 2025-03-04
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
68 participants
Primary outcome timeframe
Baseline (before treatment), post-treatment assessment (on average 12 weeks), one month follow up; Baseline scores reported.
Results posted on
2025-03-04
Participant Flow
Enrollment numbers reflect both parent and child of the parent-child dyads.
Participant milestones
| Measure |
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.
|
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".
|
|---|---|---|
|
Overall Study
STARTED
|
66
|
70
|
|
Overall Study
COMPLETED
|
60
|
62
|
|
Overall Study
NOT COMPLETED
|
6
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Parent-based Treatment for Youth With Anxiety and Obsessive-compulsive Disorder
Baseline characteristics by cohort
| Measure |
Standard SPACE
n=33 Participants
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.
|
Bibliotherapy, Low Therapist Contact SPACE
n=35 Participants
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".
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
33 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
68 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
10.2 years
STANDARD_DEVIATION 2.6 • n=99 Participants
|
10.2 years
STANDARD_DEVIATION 2.8 • n=107 Participants
|
10.2 years
STANDARD_DEVIATION 2.7 • n=206 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
33 participants
n=99 Participants
|
35 participants
n=107 Participants
|
68 participants
n=206 Participants
|
|
Clinical Global Impressions Scale-Severity
|
3.48 units on a scale
STANDARD_DEVIATION .67 • n=99 Participants
|
3.54 units on a scale
STANDARD_DEVIATION .82 • n=107 Participants
|
3.51 units on a scale
STANDARD_DEVIATION .74 • n=206 Participants
|
|
Pediatric Anxiety Rating Scale-Revised
|
17.63 units on a scale
STANDARD_DEVIATION 2.67 • n=99 Participants
|
16.51 units on a scale
STANDARD_DEVIATION 4.14 • n=107 Participants
|
17.06 units on a scale
STANDARD_DEVIATION 3.52 • n=206 Participants
|
PRIMARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Standard SPACE
n=30 Participants
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.
|
Bibliotherapy, Low Therapist Contact SPACE
n=31 Participants
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".
|
|---|---|---|
|
Pediatric Anxiety Rating Scale
|
10.86 score on a scale
Standard Deviation 4.80
|
10.96 score on a scale
Standard Deviation 6.08
|
SECONDARY outcome
Timeframe: Up to 24 weeksClinician-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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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.
Clinician-rated child psychopathology severity rating. A single item is scored 0-6 (0= no illness; 6= extremely severe symptoms).
Outcome measures
| Measure |
Standard SPACE
n=30 Participants
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.
|
Bibliotherapy, Low Therapist Contact SPACE
n=31 Participants
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".
|
|---|---|---|
|
Clinical Global Impression-Severity
|
2.42 score on a scale
Standard Deviation 0.89
|
2.52 score on a scale
Standard Deviation 0.93
|
Adverse Events
Standard SPACE
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Bibliotherapy, Low Therapist Contact SPACE
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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