Trial Outcomes & Findings for Cognitive-Behavioral Treatment for Anxiety Disorders in Children With Autism Spectrum Disorders (NCT NCT01178385)
NCT ID: NCT01178385
Last Updated: 2013-04-02
Results Overview
This scale assesses the severity of anxiety symptoms. The scale ranges from 0 (minimum score) to 25 (maximum score). Higher scores reflect more severe anxiety symptoms; lower scores reflect lower anxiety severity. There are no subscales to this measure.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
45 participants
Primary outcome timeframe
After an average of 16 weeks (Post-treatment)
Results posted on
2013-04-02
Participant Flow
Forty-five children between 7-11 years (M=8.89, SD=1.34) were recruited through referrals, advertisements, and the patient flow at a university-based mental health clinic. Recruitment took place between March, 2010 and ended around January, 2012.
Seventy-one youth were assessed for eligibility. Twenty-six were excluded because they did not meet eligibility criteria (Did not meet IQ criteria (n=6); Did not meet anxiety criteria (n=9); Parent unwilling or unable to accompany child to all sessions (n=4); No autism spectrum disorder diagnosis (n=7)).
Participant milestones
| Measure |
Cognitive-behavioral Therapy
Therapists will work with families for 16 weekly sessions implementing the Behavioral Interventions for Anxiety in Children with Autism (BIACA) CBT program, which is a modified version of a family CBT treatment manual for typically developing children with anxiety disorders. The BIACA intervention program is flexible in nature and employs a modular format. Despite the added flexibility of the modular format, a minimum of three sessions are spent on basic coping skills and eight are spent on in vivo exposure to ensure an adequate and comparable dose of the core elements of CBT for anxiety across cases.
|
Treatment as Usual
Participants randomized to this arm 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). Treatment changes (e.g., medication increase, starting psychotherapy in the 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.
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
21
|
|
Overall Study
COMPLETED
|
22
|
21
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Cognitive-behavioral Therapy
Therapists will work with families for 16 weekly sessions implementing the Behavioral Interventions for Anxiety in Children with Autism (BIACA) CBT program, which is a modified version of a family CBT treatment manual for typically developing children with anxiety disorders. The BIACA intervention program is flexible in nature and employs a modular format. Despite the added flexibility of the modular format, a minimum of three sessions are spent on basic coping skills and eight are spent on in vivo exposure to ensure an adequate and comparable dose of the core elements of CBT for anxiety across cases.
|
Treatment as Usual
Participants randomized to this arm 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). Treatment changes (e.g., medication increase, starting psychotherapy in the 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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
Baseline Characteristics
Cognitive-Behavioral Treatment for Anxiety Disorders in Children With Autism Spectrum Disorders
Baseline characteristics by cohort
| Measure |
Cognitive-behavioral Therapy
n=24 Participants
Therapists will work with families for 16 weekly sessions implementing the Behavioral Interventions for Anxiety in Children with Autism (BIACA) CBT program, which is a modified version of a family CBT treatment manual for typically developing children with anxiety disorders. The BIACA intervention program is flexible in nature and employs a modular format. Despite the added flexibility of the modular format, a minimum of three sessions are spent on basic coping skills and eight are spent on in vivo exposure to ensure an adequate and comparable dose of the core elements of CBT for anxiety across cases.
|
Treatment as Usual
n=21 Participants
Participants randomized to this arm 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). Treatment changes (e.g., medication increase, starting psychotherapy in the 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.
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
24 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
8.83 years
STANDARD_DEVIATION 1.31 • n=5 Participants
|
8.95 years
STANDARD_DEVIATION 1.40 • n=7 Participants
|
8.89 years
STANDARD_DEVIATION 1.34 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=5 Participants
|
21 participants
n=7 Participants
|
45 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: After an average of 16 weeks (Post-treatment)This scale assesses the severity of anxiety symptoms. The scale ranges from 0 (minimum score) to 25 (maximum score). Higher scores reflect more severe anxiety symptoms; lower scores reflect lower anxiety severity. There are no subscales to this measure.
Outcome measures
| Measure |
Cognitive-behavioral Therapy
n=24 Participants
Therapists will work with families for 16 weekly sessions implementing the Behavioral Interventions for Anxiety in Children with Autism (BIACA) CBT program, which is a modified version of a family CBT treatment manual for typically developing children with anxiety disorders. The BIACA intervention program is flexible in nature and employs a modular format. Despite the added flexibility of the modular format, a minimum of three sessions are spent on basic coping skills and eight are spent on in vivo exposure to ensure an adequate and comparable dose of the core elements of CBT for anxiety across cases.
|
Treatment as Usual
n=21 Participants
Participants randomized to this arm 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). Treatment changes (e.g., medication increase, starting psychotherapy in the 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.
|
|---|---|---|
|
Pediatric Anxiety Rating Scale (Measures the Severity of Anxiety Symptoms)
Baseline
|
16.33 units on a scale
Standard Deviation 1.93
|
17.62 units on a scale
Standard Deviation 2.04
|
|
Pediatric Anxiety Rating Scale (Measures the Severity of Anxiety Symptoms)
Post-treatment
|
11.58 units on a scale
Standard Deviation 3.15
|
16.05 units on a scale
Standard Deviation 3.22
|
SECONDARY outcome
Timeframe: After an average of 16 weeks (Post-treatment)This is a measure of severity of the child's primary anxiety disorder. The maximum rating is 8, the minimum rating is 0. Higher scores correspond to more severe anxiety.
Outcome measures
| Measure |
Cognitive-behavioral Therapy
n=24 Participants
Therapists will work with families for 16 weekly sessions implementing the Behavioral Interventions for Anxiety in Children with Autism (BIACA) CBT program, which is a modified version of a family CBT treatment manual for typically developing children with anxiety disorders. The BIACA intervention program is flexible in nature and employs a modular format. Despite the added flexibility of the modular format, a minimum of three sessions are spent on basic coping skills and eight are spent on in vivo exposure to ensure an adequate and comparable dose of the core elements of CBT for anxiety across cases.
|
Treatment as Usual
n=21 Participants
Participants randomized to this arm 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). Treatment changes (e.g., medication increase, starting psychotherapy in the 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.
|
|---|---|---|
|
Anxiety Disorders Interview Schedule Highest Anxiety Clincian Severity Rating (Measures the Severity of the Child's Anxiety Symptoms)
Baseline
|
5.42 units on a scale
Standard Deviation .72
|
5.62 units on a scale
Standard Deviation .92
|
|
Anxiety Disorders Interview Schedule Highest Anxiety Clincian Severity Rating (Measures the Severity of the Child's Anxiety Symptoms)
Post-treatment
|
3.38 units on a scale
Standard Deviation 1.81
|
4.9 units on a scale
Standard Deviation 1.51
|
SECONDARY outcome
Timeframe: After an average of 16 weeks (Post-treatment)This scale measures severity of the child's overall anxiety presentation. The minimum rating is 0, the maximum is 6. Higher scores correspond to greater anxiety; lower scores correspond to less severe anxiety. There are no subscales for this measure.
Outcome measures
| Measure |
Cognitive-behavioral Therapy
n=24 Participants
Therapists will work with families for 16 weekly sessions implementing the Behavioral Interventions for Anxiety in Children with Autism (BIACA) CBT program, which is a modified version of a family CBT treatment manual for typically developing children with anxiety disorders. The BIACA intervention program is flexible in nature and employs a modular format. Despite the added flexibility of the modular format, a minimum of three sessions are spent on basic coping skills and eight are spent on in vivo exposure to ensure an adequate and comparable dose of the core elements of CBT for anxiety across cases.
|
Treatment as Usual
n=21 Participants
Participants randomized to this arm 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). Treatment changes (e.g., medication increase, starting psychotherapy in the 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.
|
|---|---|---|
|
Clinical Global Impression - Severity Scale (This Scale Measures the Severity of the Child's Anxiety Symptoms).
Baseline
|
3.5 units on a scale
Standard Deviation .72
|
4 units on a scale
Standard Deviation .63
|
|
Clinical Global Impression - Severity Scale (This Scale Measures the Severity of the Child's Anxiety Symptoms).
Post-treatment
|
2.67 units on a scale
Standard Deviation .48
|
3.57 units on a scale
Standard Deviation .87
|
Adverse Events
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