Trial Outcomes & Findings for Parent-Led Cognitive-Behavioral Teletherapy for Anxiety in Youth With ASD (NCT NCT04111874)

Last Updated: 2025-01-15

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 30.

Recruitment status

COMPLETED

Study phase

Target enrollment

87 participants

Primary outcome timeframe

Baseline (before treatment), post-treatment (on average 12 weeks), 3 month follow up; Post-treatment scores reported.

Results posted on

2025-01-15

Participant Flow

Participant milestones

Participant milestones
Measure	Low-Intensity Therapist Assistance (LTA) Parents will receive four 30-minute supportive video calls with a therapist over the 12 weeks of treatment. Cognitive Behavioral Teletherapy LTA: Participating families will receive a copy of the book 'Helping Your Anxious Child, 2nd Edition', as well as the companion parent and child workbooks, to use at home and in session with the therapist. During each of the four videoconferencing sessions, therapists will serve to provide encouragement and support as the parent works through the program independently.	Standard Therapist Assistance (STA) Parents will receive ten 60-minute supportive video calls with a therapist over the 12 weeks of treatment. Cognitive Behavioral Teletherapy STA: Participating families will also receive a copy of the book 'Helping Your Anxious Child, 2nd Edition', as well as the companion parent and child workbooks, to use at home and in session with the therapist. During each of the ten videoconferencing sessions, therapists will guide the parent through the implementation of the program, including explaining materials, assisting to develop planned therapy activities with the child, and problem-solving as needed.
Overall Study STARTED	48	39
Overall Study COMPLETED	31	35
Overall Study NOT COMPLETED	17	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Individuals were randomly assigned to different conditions

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Baseline (before treatment), post-treatment (on average 12 weeks), 3 month follow up; Post-treatment scores reported.

Population: Results for the post-treatment assessment

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 30.

Outcome measures

Outcome measures
Measure	Low-Intensity Therapist Assistance (LTA) n=31 Participants Parents will receive four 30-minute supportive video calls with a therapist over the 12 weeks of treatment. Cognitive Behavioral Teletherapy LTA: Participating families will receive a copy of the book 'Helping Your Anxious Child, 2nd Edition', as well as the companion parent and child workbooks, to use at home and in session with the therapist. During each of the four videoconferencing sessions, therapists will serve to provide encouragement and support as the parent works through the program independently.	Standard Therapist Assistance (STA) n=33 Participants Parents will receive ten 60-minute supportive video calls with a therapist over the 12 weeks of treatment. Cognitive Behavioral Teletherapy STA: Participating families will also receive a copy of the book 'Helping Your Anxious Child, 2nd Edition', as well as the companion parent and child workbooks, to use at home and in session with the therapist. During each of the ten videoconferencing sessions, therapists will guide the parent through the implementation of the program, including explaining materials, assisting to develop planned therapy activities with the child, and problem-solving as needed.
6-item Pediatric Anxiety Rating Scale	11.35 Score on a scale Standard Deviation 5.36	10.26 Score on a scale Standard Deviation 4.17

PRIMARY outcome

Timeframe: Each treatment session, post-treatment (on average 12 weeks), 3 month follow up; Post-treatment scores reported.

Population: count of participants who were classified as "much" or "very much improved" on the CGI-I at the end of treatment

Clinician rated child psychopathology improvement since initial rating. A single item is scored 0-6 (0 = very much worse; 6= very much improved).

Outcome measures

Outcome measures
Measure	Low-Intensity Therapist Assistance (LTA) n=31 Participants Parents will receive four 30-minute supportive video calls with a therapist over the 12 weeks of treatment. Cognitive Behavioral Teletherapy LTA: Participating families will receive a copy of the book 'Helping Your Anxious Child, 2nd Edition', as well as the companion parent and child workbooks, to use at home and in session with the therapist. During each of the four videoconferencing sessions, therapists will serve to provide encouragement and support as the parent works through the program independently.	Standard Therapist Assistance (STA) n=33 Participants Parents will receive ten 60-minute supportive video calls with a therapist over the 12 weeks of treatment. Cognitive Behavioral Teletherapy STA: Participating families will also receive a copy of the book 'Helping Your Anxious Child, 2nd Edition', as well as the companion parent and child workbooks, to use at home and in session with the therapist. During each of the ten videoconferencing sessions, therapists will guide the parent through the implementation of the program, including explaining materials, assisting to develop planned therapy activities with the child, and problem-solving as needed.
Clinical Global Impression-Improvement	21 Participants	23 Participants

SECONDARY outcome

Timeframe: Baseline (before treatment), Each treatment session, post-treatment (on average 12 weeks), 3 month follow up; Post-treatment scores reported.

Population: These scores are reported for the post-treatment assessment

Clinician rated child psychopathology severity rating. A single item is scored 0-6 (0= no illness; 6= extremely severe symptoms).

Outcome measures

Outcome measures
Measure	Low-Intensity Therapist Assistance (LTA) n=31 Participants Parents will receive four 30-minute supportive video calls with a therapist over the 12 weeks of treatment. Cognitive Behavioral Teletherapy LTA: Participating families will receive a copy of the book 'Helping Your Anxious Child, 2nd Edition', as well as the companion parent and child workbooks, to use at home and in session with the therapist. During each of the four videoconferencing sessions, therapists will serve to provide encouragement and support as the parent works through the program independently.	Standard Therapist Assistance (STA) n=33 Participants Parents will receive ten 60-minute supportive video calls with a therapist over the 12 weeks of treatment. Cognitive Behavioral Teletherapy STA: Participating families will also receive a copy of the book 'Helping Your Anxious Child, 2nd Edition', as well as the companion parent and child workbooks, to use at home and in session with the therapist. During each of the ten videoconferencing sessions, therapists will guide the parent through the implementation of the program, including explaining materials, assisting to develop planned therapy activities with the child, and problem-solving as needed.
Clinical Global Impression-Severity	2.83 Score on a scale Standard Deviation 1.07	2.59 Score on a scale Standard Deviation 1.08

Adverse Events

Low-Intensity Therapist Assistance (LTA)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Therapist Assistance (STA)

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. Andrew Guzick

University of Pennsylvania

Phone: 215-573-3708

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Low-Intensity Therapist Assistance (LTA) n=48 Participants Parents will receive four 30-minute supportive video calls with a therapist over the 12 weeks of treatment. Cognitive Behavioral Teletherapy LTA: Participating families will receive a copy of the book 'Helping Your Anxious Child, 2nd Edition', as well as the companion parent and child workbooks, to use at home and in session with the therapist. During each of the four videoconferencing sessions, therapists will serve to provide encouragement and support as the parent works through the program independently.	Standard Therapist Assistance (STA) n=39 Participants Parents will receive ten 60-minute supportive video calls with a therapist over the 12 weeks of treatment. Cognitive Behavioral Teletherapy STA: Participating families will also receive a copy of the book 'Helping Your Anxious Child, 2nd Edition', as well as the companion parent and child workbooks, to use at home and in session with the therapist. During each of the ten videoconferencing sessions, therapists will guide the parent through the implementation of the program, including explaining materials, assisting to develop planned therapy activities with the child, and problem-solving as needed.	Total n=87 Participants Total of all reporting groups
Age, Categorical <=18 years	48 Participants n=48 Participants • Individuals were randomly assigned to different conditions	39 Participants n=39 Participants • Individuals were randomly assigned to different conditions	87 Participants n=87 Participants • Individuals were randomly assigned to different conditions
Age, Categorical Between 18 and 65 years	0 Participants n=48 Participants • Individuals were randomly assigned to different conditions	0 Participants n=39 Participants • Individuals were randomly assigned to different conditions	0 Participants n=87 Participants • Individuals were randomly assigned to different conditions
Age, Categorical >=65 years	0 Participants n=48 Participants • Individuals were randomly assigned to different conditions	0 Participants n=39 Participants • Individuals were randomly assigned to different conditions	0 Participants n=87 Participants • Individuals were randomly assigned to different conditions
Age, Continuous	10.1 years STANDARD_DEVIATION 1.8 • n=48 Participants • Participants were randomly assigned to different conditions	10.3 years STANDARD_DEVIATION 1.8 • n=39 Participants • Participants were randomly assigned to different conditions	10.2 years STANDARD_DEVIATION 1.8 • n=87 Participants • Participants were randomly assigned to different conditions
Sex: Female, Male Female	8 Participants n=46 Participants • Participants were randomly assigned to different conditions	8 Participants n=38 Participants • Participants were randomly assigned to different conditions	16 Participants n=84 Participants • Participants were randomly assigned to different conditions
Sex: Female, Male Male	38 Participants n=46 Participants • Participants were randomly assigned to different conditions	30 Participants n=38 Participants • Participants were randomly assigned to different conditions	68 Participants n=84 Participants • Participants were randomly assigned to different conditions
Ethnicity (NIH/OMB) Hispanic or Latino	17 Participants n=48 Participants • Participants were randomly assigned to different conditions	11 Participants n=39 Participants • Participants were randomly assigned to different conditions	28 Participants n=87 Participants • Participants were randomly assigned to different conditions
Ethnicity (NIH/OMB) Not Hispanic or Latino	29 Participants n=48 Participants • Participants were randomly assigned to different conditions	27 Participants n=39 Participants • Participants were randomly assigned to different conditions	56 Participants n=87 Participants • Participants were randomly assigned to different conditions
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=48 Participants • Participants were randomly assigned to different conditions	1 Participants n=39 Participants • Participants were randomly assigned to different conditions	3 Participants n=87 Participants • Participants were randomly assigned to different conditions
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=48 Participants • Participants were randomly assigned to different conditions	2 Participants n=39 Participants • Participants were randomly assigned to different conditions	3 Participants n=87 Participants • Participants were randomly assigned to different conditions
Race (NIH/OMB) Asian	3 Participants n=48 Participants • Participants were randomly assigned to different conditions	0 Participants n=39 Participants • Participants were randomly assigned to different conditions	3 Participants n=87 Participants • Participants were randomly assigned to different conditions
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=48 Participants • Participants were randomly assigned to different conditions	0 Participants n=39 Participants • Participants were randomly assigned to different conditions	0 Participants n=87 Participants • Participants were randomly assigned to different conditions
Race (NIH/OMB) Black or African American	2 Participants n=48 Participants • Participants were randomly assigned to different conditions	2 Participants n=39 Participants • Participants were randomly assigned to different conditions	4 Participants n=87 Participants • Participants were randomly assigned to different conditions
Race (NIH/OMB) White	33 Participants n=48 Participants • Participants were randomly assigned to different conditions	23 Participants n=39 Participants • Participants were randomly assigned to different conditions	56 Participants n=87 Participants • Participants were randomly assigned to different conditions
Race (NIH/OMB) More than one race	7 Participants n=48 Participants • Participants were randomly assigned to different conditions	11 Participants n=39 Participants • Participants were randomly assigned to different conditions	18 Participants n=87 Participants • Participants were randomly assigned to different conditions
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=48 Participants • Participants were randomly assigned to different conditions	1 Participants n=39 Participants • Participants were randomly assigned to different conditions	3 Participants n=87 Participants • Participants were randomly assigned to different conditions
Region of Enrollment United States	48 participants n=48 Participants • Participants were randomly assigned to different conditions	39 participants n=39 Participants • Participants were randomly assigned to different conditions	87 participants n=87 Participants • Participants were randomly assigned to different conditions