Trial Outcomes & Findings for Psychotherapy for Anxiety in Children With Autism Spectrum Disorder (NCT NCT02028247)
NCT ID: NCT02028247
Last Updated: 2021-11-15
Results Overview
This measure is administered by a clinician and assesses anxiety symptom severity on a scale from 0-25 with higher scores corresponding to worse anxiety.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
214 participants
Primary outcome timeframe
Baseline and After 16 Weeks of Treatment
Results posted on
2021-11-15
Participant Flow
Two-hundred and fourteen children between 7-13 years (M=9.96, SD=1.76) were recruited through referrals, advertisements, and the patient flow of three university-based mental health clinics. Recruitment began April 2014 and final data were collected around January 2017.
Of the 214 participants enrolled in the study, a total of 47 children were excluded before assignment to groups because they did not meet eligibility criteria (did not meet IQ criteria (n=6); did not meet anxiety criteria or anxiety was not primary (n=16); no autism spectrum disorder criteria (n=17); parent unwilling or unable to adhere to study procedures (n=7); child needed a higher level of care (n=1)). Thus, only 167 children were assigned across the three groups.
Participant milestones
| Measure |
Personalized Cognitive-behavioral Therapy
Personalized Cognitive-behavioral therapy involves 16 weekly individual therapy sessions, up to 90 minutes each, based on a treatment protocol that has been designed specifically for youth with high-functioning autism spectrum disorders.
Personalized Cognitive-behavioral therapy
|
Standard Practice Cognitive-behavioral Therapy
Standard Practice Cognitive-behavioral therapy involves 16 weekly individual therapy sessions, up to 60 minutes each, based on a treatment protocol that represent the standard practice psychotherapy for anxiety that has been found to be effective in multiple trials in youngsters without autism spectrum disorders.
Standard Practice Cognitive-behavioral therapy
|
Treatment as Usual
Participants randomized to the TAU condition will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions) for a 16-week period. Treatment changes (e.g., medication increase, starting psychotherapy in community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice; and will be monitored through periodic study assessment.
Treatment as Usual
|
|---|---|---|---|
|
Overall Study
STARTED
|
77
|
71
|
19
|
|
Overall Study
COMPLETED
|
67
|
59
|
15
|
|
Overall Study
NOT COMPLETED
|
10
|
12
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Psychotherapy for Anxiety in Children With Autism Spectrum Disorder
Baseline characteristics by cohort
| Measure |
Personalized Cognitive-behavioral Therapy
n=77 Participants
Personalized Cognitive-behavioral therapy involves 16 weekly individual therapy sessions, up to 90 minutes each, based on a treatment protocol that has been designed specifically for youth with high-functioning autism spectrum disorders.
Personalized Cognitive-behavioral therapy
|
Standard Practice Cognitive-behavioral Therapy
n=71 Participants
Standard Practice Cognitive-behavioral therapy involves 16 weekly individual therapy sessions, up to 60 minutes each, based on a treatment protocol that represent the standard practice psychotherapy for anxiety that has been found to be effective in multiple trials in youngsters without autism spectrum disorders.
Standard Practice Cognitive-behavioral therapy
|
Treatment as Usual
n=19 Participants
Participants randomized to the TAU condition will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions) for a 16-week period. Treatment changes (e.g., medication increase, starting psychotherapy in community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice; and will be monitored through periodic study assessment.
Treatment as Usual
|
Total
n=167 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
77 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
167 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
9.71 years
STANDARD_DEVIATION 1.86 • n=5 Participants
|
10.03 years
STANDARD_DEVIATION 1.66 • n=7 Participants
|
10.05 years
STANDARD_DEVIATION 1.75 • n=5 Participants
|
9.90 years
STANDARD_DEVIATION 1.78 • n=4 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
56 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
134 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
58 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
128 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
77 participants
n=5 Participants
|
71 participants
n=7 Participants
|
19 participants
n=5 Participants
|
167 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and After 16 Weeks of TreatmentPopulation: Not all participants who were randomized to each of the intervention arms completed the Pediatric Anxiety Rating Scale (at baseline and/or post-treatment).
This measure is administered by a clinician and assesses anxiety symptom severity on a scale from 0-25 with higher scores corresponding to worse anxiety.
Outcome measures
| Measure |
Personalized Cognitive-behavioral Therapy
n=77 Participants
Personalized Cognitive-behavioral therapy involves 16 weekly individual therapy sessions, up to 90 minutes each, based on a treatment protocol that has been designed specifically for youth with high-functioning autism spectrum disorders.
Personalized Cognitive-behavioral therapy
|
Standard Practice Cognitive-behavioral Therapy
n=69 Participants
Standard Practice Cognitive-behavioral therapy involves 16 weekly individual therapy sessions, up to 60 minutes each, based on a treatment protocol that represent the standard practice psychotherapy for anxiety that has been found to be effective in multiple trials in youngsters without autism spectrum disorders.
Standard Practice Cognitive-behavioral therapy
|
Treatment as Usual
n=19 Participants
Participants randomized to the TAU condition will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions) for a 16-week period. Treatment changes (e.g., medication increase, starting psychotherapy in community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice; and will be monitored through periodic study assessment.
Treatment as Usual
|
|---|---|---|---|
|
Change From Baseline in Anxiety Severity on the Pediatric Anxiety Rating Scale After 16 Weeks of Treatment.
Baseline
|
3.43 units on a scale
Standard Deviation 0.48
|
3.47 units on a scale
Standard Deviation 0.47
|
3.28 units on a scale
Standard Deviation 0.39
|
|
Change From Baseline in Anxiety Severity on the Pediatric Anxiety Rating Scale After 16 Weeks of Treatment.
Post-treatment
|
2.13 units on a scale
Standard Deviation 0.91
|
2.43 units on a scale
Standard Deviation 0.70
|
2.93 units on a scale
Standard Deviation 0.59
|
SECONDARY outcome
Timeframe: After 16 weeks of treatmentPopulation: Of the 167 participants assigned to groups, only 145 completed treatment (67 in personalized CBT, 60 in standard CBT, and 18 in treatment as usual). For 3 participants (1 in personalized CBT and 2 in standard CBT), the Clinical Global Impressions-Improvement Scale was not completed at the end of treatment.
The Clinical Global Impressions-Improvement scale (CGI-I) was completed by a clinician after 16 weeks of treatment. The CGI-I assesses the severity of anxiety on a 7 point scale, ranging from 1 (very much improved) to 7 (very much worse). A rating of 1 or 2 on the CGI-I designated a positive treatment response.
Outcome measures
| Measure |
Personalized Cognitive-behavioral Therapy
n=66 Participants
Personalized Cognitive-behavioral therapy involves 16 weekly individual therapy sessions, up to 90 minutes each, based on a treatment protocol that has been designed specifically for youth with high-functioning autism spectrum disorders.
Personalized Cognitive-behavioral therapy
|
Standard Practice Cognitive-behavioral Therapy
n=58 Participants
Standard Practice Cognitive-behavioral therapy involves 16 weekly individual therapy sessions, up to 60 minutes each, based on a treatment protocol that represent the standard practice psychotherapy for anxiety that has been found to be effective in multiple trials in youngsters without autism spectrum disorders.
Standard Practice Cognitive-behavioral therapy
|
Treatment as Usual
n=18 Participants
Participants randomized to the TAU condition will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions) for a 16-week period. Treatment changes (e.g., medication increase, starting psychotherapy in community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice; and will be monitored through periodic study assessment.
Treatment as Usual
|
|---|---|---|---|
|
Percentage of Participants With Positive Treatment Response as Assessed by the Clinical Global Impressions-Improvement Scale
|
92.42 percentage of participants
|
81.03 percentage of participants
|
11.11 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and After 16 weeks of treatmentPopulation: Not all participants who were randomized to each of the intervention arms completed the Child Behavior Checklist (at baseline and/or post-treatment).
The Child Behavior Checklist (CBCL) is completed by parents and the anxiety/depression subscale of the CBCL was used to assess anxiety/depression symptomatology. The CBCL anxiety/depression subscale is rated on a 3-point scale, ranging from 0 (Not true) to 2 (Very True), with higher scores indicating more symptoms.
Outcome measures
| Measure |
Personalized Cognitive-behavioral Therapy
n=76 Participants
Personalized Cognitive-behavioral therapy involves 16 weekly individual therapy sessions, up to 90 minutes each, based on a treatment protocol that has been designed specifically for youth with high-functioning autism spectrum disorders.
Personalized Cognitive-behavioral therapy
|
Standard Practice Cognitive-behavioral Therapy
n=69 Participants
Standard Practice Cognitive-behavioral therapy involves 16 weekly individual therapy sessions, up to 60 minutes each, based on a treatment protocol that represent the standard practice psychotherapy for anxiety that has been found to be effective in multiple trials in youngsters without autism spectrum disorders.
Standard Practice Cognitive-behavioral therapy
|
Treatment as Usual
n=17 Participants
Participants randomized to the TAU condition will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions) for a 16-week period. Treatment changes (e.g., medication increase, starting psychotherapy in community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice; and will be monitored through periodic study assessment.
Treatment as Usual
|
|---|---|---|---|
|
Change From Baseline in Anxiety/Depression Severity on the Child Behavior Checklist After 16 Weeks of Treatment.
Post-treatment
|
0.51 units on a scale
Standard Deviation 0.29
|
0.69 units on a scale
Standard Deviation 0.34
|
0.77 units on a scale
Standard Deviation 0.27
|
|
Change From Baseline in Anxiety/Depression Severity on the Child Behavior Checklist After 16 Weeks of Treatment.
Baseline
|
0.83 units on a scale
Standard Deviation 0.39
|
0.88 units on a scale
Standard Deviation 0.39
|
0.73 units on a scale
Standard Deviation 0.28
|
SECONDARY outcome
Timeframe: Baseline and After 16 weeks of treatmentPopulation: Not all participants who were randomized to each of the intervention arms completed the Childhood Anxiety Impact Scale (at baseline and/or post-treatment).
The Childhood Anxiety Impact Scale (CAIS) is a questionnaire completed by parents about the impact of the child's anxiety on functioning in three situational categories (i.e., school, social, and family functioning). The CAIS is rated on a 4-point scale, ranging from 0 (not at all) to 3 (very much). The CAIS items are summed and sorted into 3 subscales, corresponding to each situational category: school, social, and family. For all 3 subscales, higher scores correspond to more associated impact in that area.
Outcome measures
| Measure |
Personalized Cognitive-behavioral Therapy
n=76 Participants
Personalized Cognitive-behavioral therapy involves 16 weekly individual therapy sessions, up to 90 minutes each, based on a treatment protocol that has been designed specifically for youth with high-functioning autism spectrum disorders.
Personalized Cognitive-behavioral therapy
|
Standard Practice Cognitive-behavioral Therapy
n=70 Participants
Standard Practice Cognitive-behavioral therapy involves 16 weekly individual therapy sessions, up to 60 minutes each, based on a treatment protocol that represent the standard practice psychotherapy for anxiety that has been found to be effective in multiple trials in youngsters without autism spectrum disorders.
Standard Practice Cognitive-behavioral therapy
|
Treatment as Usual
n=18 Participants
Participants randomized to the TAU condition will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions) for a 16-week period. Treatment changes (e.g., medication increase, starting psychotherapy in community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice; and will be monitored through periodic study assessment.
Treatment as Usual
|
|---|---|---|---|
|
Change From Baseline in Anxiety Related Impairment as Measured by the Childhood Anxiety Impact Scale After 16 Weeks of Treatment.
Baseline - CAIS School
|
1.38 units on a scale
Standard Deviation 0.61
|
1.48 units on a scale
Standard Deviation 0.60
|
1.19 units on a scale
Standard Deviation 0.70
|
|
Change From Baseline in Anxiety Related Impairment as Measured by the Childhood Anxiety Impact Scale After 16 Weeks of Treatment.
Post - CAIS School
|
0.77 units on a scale
Standard Deviation 0.57
|
0.88 units on a scale
Standard Deviation 0.54
|
1.24 units on a scale
Standard Deviation 0.51
|
|
Change From Baseline in Anxiety Related Impairment as Measured by the Childhood Anxiety Impact Scale After 16 Weeks of Treatment.
Baseline - CAIS Social
|
0.97 units on a scale
Standard Deviation 0.56
|
0.96 units on a scale
Standard Deviation 0.62
|
0.70 units on a scale
Standard Deviation 0.54
|
|
Change From Baseline in Anxiety Related Impairment as Measured by the Childhood Anxiety Impact Scale After 16 Weeks of Treatment.
Post - CAIS Social
|
0.49 units on a scale
Standard Deviation 0.42
|
0.65 units on a scale
Standard Deviation 0.54
|
0.80 units on a scale
Standard Deviation 0.50
|
|
Change From Baseline in Anxiety Related Impairment as Measured by the Childhood Anxiety Impact Scale After 16 Weeks of Treatment.
Baseline - CAIS Family
|
1.16 units on a scale
Standard Deviation 0.63
|
1.12 units on a scale
Standard Deviation 0.62
|
0.98 units on a scale
Standard Deviation 0.44
|
|
Change From Baseline in Anxiety Related Impairment as Measured by the Childhood Anxiety Impact Scale After 16 Weeks of Treatment.
Post - CAIS Family
|
0.65 units on a scale
Standard Deviation 0.49
|
0.73 units on a scale
Standard Deviation 0.51
|
0.88 units on a scale
Standard Deviation 0.60
|
Adverse Events
Personalized Cognitive-behavioral Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Practice Cognitive-behavioral Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Treatment as Usual
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