Trial Outcomes & Findings for Group Depression Treatment for Autistic Youth (NCT NCT05430022)

Last Updated: 2024-11-08

Results Overview

Self-reported severity of depressive symptoms by autistic adolescents on the Revised Children's Anxiety and Depression Scale (RCADS). The RCADS is a 47-item scale with each item scored from 0-3, with a total possible raw score of 0-141, with higher scores indicating higher internalizing symptoms. The depression subscale of the RCADS is comprised of 10 items. Raw scores are converted to grade-based standardized T-scores (mean of 50, standard deviation of 10), and T-scores greater than 59 indicate clinically-significant symptoms. The RCADS has been validated for use with autistic youth.

Recruitment status

COMPLETED

Study phase

Target enrollment

48 participants

Primary outcome timeframe

Baseline to 6 months

Results posted on

2024-11-08

Participant Flow

Participant milestones

Participant milestones
Measure	Autism-adapted Group Cognitive Behavioral Therapy (Child Ratings) Autistic adolescents (11-17 years old; middle and high school) with depression will participate in a 12-week group intervention, autism-adapted Cognitive Behavioral Therapy, to decrease the severity of depressive symptoms. Autism-adapted Group Cognitive Behavioral Therapy: The autism-adapted Group Cognitive Behavioral Therapy (CBT) was designed by the PI and research team in collaboration with autistic community members (i.e., adults, parents, researchers). It is a 12-week group intervention (90 min) delivered on a weekly basis in an outpatient psychiatry clinic by licensed clinical psychologists and psychology trainees. Each group is comprised of 8-9 autistic adolescents (11-17 years old; middle and high school) with depression. The intervention targets adolescents' perception and understanding of self, including autistic identity, through a series of cognitive-behavioral approaches including psychoeducation, emotion regulation, cognitive distortions, cognitive restructuring, behavioral rehearsals, and weekly homework assignments.	Autism-adapted Group Cognitive Behavioral Therapy (Parent Ratings) One parent of each autistic adolescent (11-17 years old; middle and high school) with depression will provide ratings of their child as their child participates in a 12-week group intervention, autism-adapted Cognitive Behavioral Therapy, to decrease the severity of depressive symptoms. Parents did not participate in therapy sessions. Autism-adapted Group Cognitive Behavioral Therapy: The autism-adapted Group Cognitive Behavioral Therapy (CBT) was designed by the PI and research team in collaboration with autistic community members (i.e., adults, parents, researchers). It is a 12-week group intervention (90 min) delivered on a weekly basis in an outpatient psychiatry clinic by licensed clinical psychologists and psychology trainees. Each group is comprised of 8-9 autistic adolescents (11-17 years old; middle and high school) with depression. The intervention targets adolescents' perception and understanding of self, including autistic identity, through a series of cognitive-behavioral approaches including psychoeducation, emotion regulation, cognitive distortions, cognitive restructuring, behavioral rehearsals, and weekly homework assignments.
Overall Study STARTED	24	24
Overall Study COMPLETED	20	20
Overall Study NOT COMPLETED	4	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Autism-adapted Group Cognitive Behavioral Therapy (Child Ratings) Autistic adolescents (11-17 years old; middle and high school) with depression will participate in a 12-week group intervention, autism-adapted Cognitive Behavioral Therapy, to decrease the severity of depressive symptoms. Autism-adapted Group Cognitive Behavioral Therapy: The autism-adapted Group Cognitive Behavioral Therapy (CBT) was designed by the PI and research team in collaboration with autistic community members (i.e., adults, parents, researchers). It is a 12-week group intervention (90 min) delivered on a weekly basis in an outpatient psychiatry clinic by licensed clinical psychologists and psychology trainees. Each group is comprised of 8-9 autistic adolescents (11-17 years old; middle and high school) with depression. The intervention targets adolescents' perception and understanding of self, including autistic identity, through a series of cognitive-behavioral approaches including psychoeducation, emotion regulation, cognitive distortions, cognitive restructuring, behavioral rehearsals, and weekly homework assignments.	Autism-adapted Group Cognitive Behavioral Therapy (Parent Ratings) One parent of each autistic adolescent (11-17 years old; middle and high school) with depression will provide ratings of their child as their child participates in a 12-week group intervention, autism-adapted Cognitive Behavioral Therapy, to decrease the severity of depressive symptoms. Parents did not participate in therapy sessions. Autism-adapted Group Cognitive Behavioral Therapy: The autism-adapted Group Cognitive Behavioral Therapy (CBT) was designed by the PI and research team in collaboration with autistic community members (i.e., adults, parents, researchers). It is a 12-week group intervention (90 min) delivered on a weekly basis in an outpatient psychiatry clinic by licensed clinical psychologists and psychology trainees. Each group is comprised of 8-9 autistic adolescents (11-17 years old; middle and high school) with depression. The intervention targets adolescents' perception and understanding of self, including autistic identity, through a series of cognitive-behavioral approaches including psychoeducation, emotion regulation, cognitive distortions, cognitive restructuring, behavioral rehearsals, and weekly homework assignments.
Overall Study Withdrawal by Subject	4	4

Baseline Characteristics

data were not collected for the parent population

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Baseline to 6 months

Outcome measures

Outcome measures
Measure	Autism-adapted Group Cognitive Behavioral Therapy n=20 Participants Autistic adolescents (11-17 years old; middle and high school) with depression will participate in a 12-week group intervention, autism-adapted Cognitive Behavioral Therapy, to decrease the severity of depressive symptoms. Autism-adapted Group Cognitive Behavioral Therapy: The autism-adapted Group Cognitive Behavioral Therapy (CBT) was designed by the PI and research team in collaboration with autistic community members (i.e., adults, parents, researchers). It is a 12-week group intervention (90 min) delivered on a weekly basis in an outpatient psychiatry clinic by licensed clinical psychologists and psychology trainees. Each group is comprised of 8-9 autistic adolescents (11-17 years old; middle and high school) with depression. The intervention targets adolescents' perception and understanding of self, including autistic identity, through a series of cognitive-behavioral approaches including psychoeducation, emotion regulation, cognitive distortions, cognitive restructuring, behavioral rehearsals, and weekly homework assignments.
Change in Severity of Adolescent Depressive Symptoms, Self-report	8.14 T-score Standard Deviation 2.1

PRIMARY outcome

Timeframe: Baseline to 6 months

Parent-reported severity of adolescent depressive symptoms on the Revised Children's Anxiety and Depression Scale (RCADS). The RCADS is a 47-item scale with each item scored from 0-3, with a total possible raw score of 0-141, with higher scores indicating higher internalizing symptoms in adolescents. The depression subscale of the RCADS is comprised of 10 items. Raw scores are converted to grade-based standardized T-scores (mean of 50, standard deviation of 10), and T-scores greater than 59 indicate clinically-significant symptoms. The RCADS has been validated for use with autistic youth.

Outcome measures

Outcome measures
Measure	Autism-adapted Group Cognitive Behavioral Therapy n=20 Participants Autistic adolescents (11-17 years old; middle and high school) with depression will participate in a 12-week group intervention, autism-adapted Cognitive Behavioral Therapy, to decrease the severity of depressive symptoms. Autism-adapted Group Cognitive Behavioral Therapy: The autism-adapted Group Cognitive Behavioral Therapy (CBT) was designed by the PI and research team in collaboration with autistic community members (i.e., adults, parents, researchers). It is a 12-week group intervention (90 min) delivered on a weekly basis in an outpatient psychiatry clinic by licensed clinical psychologists and psychology trainees. Each group is comprised of 8-9 autistic adolescents (11-17 years old; middle and high school) with depression. The intervention targets adolescents' perception and understanding of self, including autistic identity, through a series of cognitive-behavioral approaches including psychoeducation, emotion regulation, cognitive distortions, cognitive restructuring, behavioral rehearsals, and weekly homework assignments.
Change in Severity of Adolescent Depressive Symptoms, Parent-report	3.42 T-score Standard Deviation 2.2

Adverse Events

Autism-adapted Group Cognitive Behavioral Therapy (Child Ratings)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Autism-adapted Group Cognitive Behavioral Therapy (Parent Ratings)

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

Dr. Jessica Schwartzman, Assistant Professor

University of Southern California

Phone: 3232075910

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Autism-adapted Group Cognitive Behavioral Therapy (Child Ratings) n=24 Participants Autistic adolescents (11-17 years old; middle and high school) with depression will participate in a 12-week group intervention, autism-adapted Cognitive Behavioral Therapy, to decrease the severity of depressive symptoms. Autism-adapted Group Cognitive Behavioral Therapy: The autism-adapted Group Cognitive Behavioral Therapy (CBT) was designed by the PI and research team in collaboration with autistic community members (i.e., adults, parents, researchers). It is a 12-week group intervention (90 min) delivered on a weekly basis in an outpatient psychiatry clinic by licensed clinical psychologists and psychology trainees. Each group is comprised of 8-9 autistic adolescents (11-17 years old; middle and high school) with depression. The intervention targets adolescents' perception and understanding of self, including autistic identity, through a series of cognitive-behavioral approaches including psychoeducation, emotion regulation, cognitive distortions, cognitive restructuring, behavioral rehearsals, and weekly homework assignments.	Autism-adapted Group Cognitive Behavioral Therapy (Parent Ratings) n=24 Participants One parent of each autistic adolescent (11-17 years old; middle and high school) with depression will provide ratings of their child as their child participates in a 12-week group intervention, autism-adapted Cognitive Behavioral Therapy, to decrease the severity of depressive symptoms. Parents did not participate in therapy sessions. Autism-adapted Group Cognitive Behavioral Therapy: The autism-adapted Group Cognitive Behavioral Therapy (CBT) was designed by the PI and research team in collaboration with autistic community members (i.e., adults, parents, researchers). It is a 12-week group intervention (90 min) delivered on a weekly basis in an outpatient psychiatry clinic by licensed clinical psychologists and psychology trainees. Each group is comprised of 8-9 autistic adolescents (11-17 years old; middle and high school) with depression. The intervention targets adolescents' perception and understanding of self, including autistic identity, through a series of cognitive-behavioral approaches including psychoeducation, emotion regulation, cognitive distortions, cognitive restructuring, behavioral rehearsals, and weekly homework assignments.	Total n=48 Participants Total of all reporting groups
Age, Categorical <=18 years	24 Participants n=24 Participants	0 Participants n=24 Participants	24 Participants n=48 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=24 Participants	24 Participants n=24 Participants	24 Participants n=48 Participants
Age, Categorical >=65 years	0 Participants n=24 Participants	0 Participants n=24 Participants	0 Participants n=48 Participants
Age, Continuous	13.79 years STANDARD_DEVIATION 1.96 • n=24 Participants	48.32 years STANDARD_DEVIATION 5.78 • n=24 Participants	31.06 years STANDARD_DEVIATION 3.64 • n=48 Participants
Sex: Female, Male Female	9 Participants n=24 Participants	19 Participants n=24 Participants	28 Participants n=48 Participants
Sex: Female, Male Male	15 Participants n=24 Participants	5 Participants n=24 Participants	20 Participants n=48 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=24 Participants	3 Participants n=24 Participants	7 Participants n=48 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants n=24 Participants	21 Participants n=24 Participants	41 Participants n=48 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=24 Participants	0 Participants n=24 Participants	0 Participants n=48 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=24 Participants	0 Participants n=24 Participants	0 Participants n=48 Participants
Race (NIH/OMB) Asian	0 Participants n=24 Participants	0 Participants n=24 Participants	0 Participants n=48 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=24 Participants	0 Participants n=24 Participants	0 Participants n=48 Participants
Race (NIH/OMB) Black or African American	4 Participants n=24 Participants	5 Participants n=24 Participants	9 Participants n=48 Participants
Race (NIH/OMB) White	20 Participants n=24 Participants	19 Participants n=24 Participants	39 Participants n=48 Participants
Race (NIH/OMB) More than one race	0 Participants n=24 Participants	0 Participants n=24 Participants	0 Participants n=48 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=24 Participants	0 Participants n=24 Participants	0 Participants n=48 Participants
Region of Enrollment United States	24 Participants n=24 Participants	24 Participants n=24 Participants	48 Participants n=48 Participants
Social Responsiveness Scale, Second Edition	75.64 T-score STANDARD_DEVIATION 9.1 • n=24 Participants • data were not collected for the parent population	—	75.64 T-score STANDARD_DEVIATION 9.1 • n=24 Participants • data were not collected for the parent population