Trial Outcomes & Findings for A Single-Session Intervention for Families on Waitlists for Child Anxiety Treatment (NCT NCT05841680)

NCT ID: NCT05841680

Last Updated: 2025-11-24

Results Overview

Posttreatment child rating of youth anxiety symptom severity over the past week. The name of the measure is the Screen for Child Anxiety Related Emotional Disorders - Child Version (SCARED-C). The SCARED-C is a child rated measure of the severity of youths' anxiety symptoms. Total scores on the SCARED-C range from 0 to 82, with higher scores representing more severe anxiety.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 59 participants
• Primary outcome timeframe: 1 week after first session
• Results posted on: 2025-11-24

Participant Flow

59 children were enrolled in this trial. Only children were enrolled. Parents provided parental consent for their child to participate, but were not considered enrolled. These 59 children were assigned to one of two arms: Waitlist Control or Single Session Intervention. Data were collected on these children and are reported in the Results. Data correspond to Aim 2 Test Phase Acceptability and Aim 3 Test Phase Anxiety Outcomes. Aim 1 Pilot Phase did not include quantitative data collection.

Participant milestones

Measure	Waitlist Control Participants complete pre, post, and follow-up questionnaires. They have the option to view the SSI module after completing follow-up questionnaires.	Single Session Intervention Receivers Participants complete pre then receive the SSI module. Then they complete post and follow-up questionnaires.
Overall Study STARTED	29	30
Overall Study COMPLETED	29	30
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Single-Session Intervention for Families on Waitlists for Child Anxiety Treatment

Baseline characteristics by cohort

Measure	Waitlist Control n=29 Participants Participants complete pre, post, and follow-up questionnaires. They have the option to view the SSI module after completing follow-up questionnaires.	Single Session Intervention Receivers n=30 Participants Participants complete pre then receive the SSI module. Then they complete post and follow-up questionnaires.	Total n=59 Participants Total of all reporting groups
Sex: Female, Male Female	17 Participants n=45 Participants	14 Participants n=12929 Participants	31 Participants n=6349 Participants
Sex: Female, Male Male	12 Participants n=45 Participants	16 Participants n=12929 Participants	28 Participants n=6349 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=45 Participants	1 Participants n=12929 Participants	1 Participants n=6349 Participants
Race (NIH/OMB) Asian	1 Participants n=45 Participants	0 Participants n=12929 Participants	1 Participants n=6349 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=45 Participants	0 Participants n=12929 Participants	0 Participants n=6349 Participants
Race (NIH/OMB) Black or African American	1 Participants n=45 Participants	2 Participants n=12929 Participants	3 Participants n=6349 Participants
Race (NIH/OMB) White	25 Participants n=45 Participants	26 Participants n=12929 Participants	51 Participants n=6349 Participants
Race (NIH/OMB) More than one race	2 Participants n=45 Participants	1 Participants n=12929 Participants	3 Participants n=6349 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=45 Participants	0 Participants n=12929 Participants	0 Participants n=6349 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	24 Participants n=45 Participants	25 Participants n=12929 Participants	49 Participants n=6349 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=45 Participants	5 Participants n=12929 Participants	10 Participants n=6349 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=45 Participants	0 Participants n=12929 Participants	0 Participants n=6349 Participants
Age, Categorical <=18 years	29 Participants n=45 Participants	30 Participants n=12929 Participants	59 Participants n=6349 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=45 Participants	0 Participants n=12929 Participants	0 Participants n=6349 Participants
Age, Categorical >=65 years	0 Participants n=45 Participants	0 Participants n=12929 Participants	0 Participants n=6349 Participants

PRIMARY outcome

Timeframe: 1 week after first session

Posttreatment parent rating of youth anxiety symptom severity over the past week. The name of the measure is the Screen for Child Anxiety Related Emotional Disorders - Parent Version (SCARED-P). The SCARED-P is a parent rated measure of the severity of youths' anxiety symptoms. Total scores on the SCARED-P range from 0 to 82, with higher scores representing more severe anxiety.

Outcome measures

Measure	Waitlist Control n=29 Participants Participants complete pre, post, and follow-up questionnaires. They have the option to view the SSI module after completing follow-up questionnaires.	Single Session Intervention Receivers n=30 Participants Participants complete pre then receive the SSI module. Then they complete post and follow-up questionnaires.
Screen for Child Anxiety Related Emotional Disorders - Parent Version at Posttreatment	35 units on a scale Standard Deviation 14	30 units on a scale Standard Deviation 12

PRIMARY outcome

Timeframe: 1 week after first session

Posttreatment child rating of youth anxiety symptom severity over the past week. The name of the measure is the Screen for Child Anxiety Related Emotional Disorders - Child Version (SCARED-C). The SCARED-C is a child rated measure of the severity of youths' anxiety symptoms. Total scores on the SCARED-C range from 0 to 82, with higher scores representing more severe anxiety.

Outcome measures

Measure	Waitlist Control n=29 Participants Participants complete pre, post, and follow-up questionnaires. They have the option to view the SSI module after completing follow-up questionnaires.	Single Session Intervention Receivers n=30 Participants Participants complete pre then receive the SSI module. Then they complete post and follow-up questionnaires.
Screen for Child Anxiety Related Emotional Disorders - Child Version at Posttreatment	33 units on a scale Standard Deviation 14	23 units on a scale Standard Deviation 12

PRIMARY outcome

Timeframe: 4 weeks after first session

Follow up parent rating of youth anxiety symptom severity over the past 3 weeks. The name of the measure is the Screen for Child Anxiety Related Emotional Disorders - Parent Version (SCARED-P). The SCARED-P is a parent rated measure of the severity of youths' anxiety symptoms. Total scores on the SCARED-P range from 0 to 82, with higher scores representing more severe anxiety.

Outcome measures

Measure	Waitlist Control n=29 Participants Participants complete pre, post, and follow-up questionnaires. They have the option to view the SSI module after completing follow-up questionnaires.	Single Session Intervention Receivers n=30 Participants Participants complete pre then receive the SSI module. Then they complete post and follow-up questionnaires.
Screen for Child Anxiety Related Emotional Disorders - Parent Version at Follow up	34 units on a scale Standard Deviation 13	26 units on a scale Standard Deviation 14

PRIMARY outcome

Timeframe: 4 weeks after first session

Follow up child rating of youth anxiety symptom severity over the past 3 weeks. The name of the measure is the Screen for Child Anxiety Related Emotional Disorders - Child Version (SCARED-C). The SCARED-C is a child rated measure of the severity of youths' anxiety symptoms. Total scores on the SCARED-C range from 0 to 82, with higher scores representing more severe anxiety.

Outcome measures

Measure	Waitlist Control n=29 Participants Participants complete pre, post, and follow-up questionnaires. They have the option to view the SSI module after completing follow-up questionnaires.	Single Session Intervention Receivers n=30 Participants Participants complete pre then receive the SSI module. Then they complete post and follow-up questionnaires.
Screen for Child Anxiety Related Emotional Disorders - Child Version at Follow-Up	31 units on a scale Standard Deviation 14	23 units on a scale Standard Deviation 13

SECONDARY outcome

Timeframe: first session at baseline

Child rating of youth anxiety symptom severity over the past month. The name of the measure is the Screen for Child Anxiety Related Emotional Disorders - Child Version (SCARED-C). The SCARED-C is a child rated measure of the severity of youths' anxiety symptoms. Total scores on the SCARED-C range from 0 to 82, with higher scores representing more severe anxiety.

Outcome measures

Measure	Waitlist Control n=29 Participants Participants complete pre, post, and follow-up questionnaires. They have the option to view the SSI module after completing follow-up questionnaires.	Single Session Intervention Receivers n=30 Participants Participants complete pre then receive the SSI module. Then they complete post and follow-up questionnaires.
Screen for Child Anxiety Related Emotional Disorders - Child Version at Pre	36 units on a scale Standard Deviation 13	36 units on a scale Standard Deviation 10

SECONDARY outcome

Timeframe: first session at baseline

Parent rating of youth anxiety symptom severity over the past month. The name of the measure is the Screen for Child Anxiety Related Emotional Disorders - Parent Version (SCARED-P). The SCARED-P is a parent rated measure of the severity of youths' anxiety symptoms. Total scores on the SCARED-P range from 0 to 82, with higher scores representing more severe anxiety.

Outcome measures

Measure	Waitlist Control n=29 Participants Participants complete pre, post, and follow-up questionnaires. They have the option to view the SSI module after completing follow-up questionnaires.	Single Session Intervention Receivers n=30 Participants Participants complete pre then receive the SSI module. Then they complete post and follow-up questionnaires.
Screen for Child Anxiety Related Emotional Disorders - Parent Version at Pre	34 units on a scale Standard Deviation 13	37 units on a scale Standard Deviation 13

SECONDARY outcome

Timeframe: first session at baseline

Brief parent-report measure of anxiety-related functional impairment over the past month. The name of the measure is the Child Anxiety Impact Scale-Parent Version (CAIS-P). The CAIS-P is a parent rated measure of anxiety-related functional impairment. Total scores on the CAIS-P range from 0 to 81, with higher scores representing more functional impairment.

Outcome measures

Measure	Waitlist Control n=29 Participants Participants complete pre, post, and follow-up questionnaires. They have the option to view the SSI module after completing follow-up questionnaires.	Single Session Intervention Receivers n=30 Participants Participants complete pre then receive the SSI module. Then they complete post and follow-up questionnaires.
Child Anxiety Impact Scale - Parent Version at Pre	28 units on a scale Standard Deviation 14	22 units on a scale Standard Deviation 15

SECONDARY outcome

Timeframe: first session at baseline

Brief youth-report measure of anxiety-related functional impairment over the past month. The name of the measure is the Child Anxiety Impact Scale-Child/Adolescent Version (CAIS-C). The CAIS-C is a parent rated measure of anxiety-related functional impairment. Total scores on the CAIS-C range from 0 to 81, with higher scores representing more functional impairment.

Outcome measures

Measure	Waitlist Control n=29 Participants Participants complete pre, post, and follow-up questionnaires. They have the option to view the SSI module after completing follow-up questionnaires.	Single Session Intervention Receivers n=30 Participants Participants complete pre then receive the SSI module. Then they complete post and follow-up questionnaires.
Child Anxiety Impact Scale - Child Version at Pre	24 units on a scale Standard Deviation 14.	19 units on a scale Standard Deviation 11

SECONDARY outcome

Timeframe: 1 week after first session

Brief parent-report measure of anxiety-related functional impairment over the past week. The name of the measure is the Child Anxiety Impact Scale-Parent Version (CAIS-P). The CAIS-P is a parent rated measure of anxiety-related functional impairment. Total scores on the CAIS-P range from 0 to 81, with higher scores representing more functional impairment.

Outcome measures

Measure	Waitlist Control n=29 Participants Participants complete pre, post, and follow-up questionnaires. They have the option to view the SSI module after completing follow-up questionnaires.	Single Session Intervention Receivers n=30 Participants Participants complete pre then receive the SSI module. Then they complete post and follow-up questionnaires.
Child Anxiety Impact Scale - Parent Version at Posttreatment	27 units on a scale Standard Deviation 15	18 units on a scale Standard Deviation 14

SECONDARY outcome

Timeframe: 1 week after first session

Brief youth-report measure of anxiety-related functional impairment over the past week. The name of the measure is the Child Anxiety Impact Scale-Child/Adolescent Version (CAIS-C). The CAIS-C is a parent rated measure of anxiety-related functional impairment. Total scores on the CAIS-C range from 0 to 81, with higher scores representing more functional impairment.

Outcome measures

Measure	Waitlist Control n=29 Participants Participants complete pre, post, and follow-up questionnaires. They have the option to view the SSI module after completing follow-up questionnaires.	Single Session Intervention Receivers n=30 Participants Participants complete pre then receive the SSI module. Then they complete post and follow-up questionnaires.
Child Anxiety Impact Scale - Child Version at Posttreatment	21 units on a scale Standard Deviation 12	17 units on a scale Standard Deviation 14

SECONDARY outcome

Timeframe: 4 weeks after first session

Brief parent-report measure of anxiety-related functional impairment over the past 3 weeks. The name of the measure is the Child Anxiety Impact Scale-Parent Version (CAIS-P). The CAIS-P is a parent rated measure of anxiety-related functional impairment. Total scores on the CAIS-P range from 0 to 81, with higher scores representing more functional impairment.

Outcome measures

Measure	Waitlist Control n=29 Participants Participants complete pre, post, and follow-up questionnaires. They have the option to view the SSI module after completing follow-up questionnaires.	Single Session Intervention Receivers n=30 Participants Participants complete pre then receive the SSI module. Then they complete post and follow-up questionnaires.
Child Anxiety Impact Scale - Parent Version at Follow Up	25 units on a scale Standard Deviation 15	15 units on a scale Standard Deviation 13

SECONDARY outcome

Timeframe: 4 weeks after first session

Brief youth-report measure of anxiety-related functional impairment over the past 3 weeks. The name of the measure is the Child Anxiety Impact Scale-Child/Adolescent Version (CAIS-C). The CAIS-C is a parent rated measure of anxiety-related functional impairment. Total scores on the CAIS-C range from 0 to 81, with higher scores representing more functional impairment.

Outcome measures

Measure	Waitlist Control n=29 Participants Participants complete pre, post, and follow-up questionnaires. They have the option to view the SSI module after completing follow-up questionnaires.	Single Session Intervention Receivers n=30 Participants Participants complete pre then receive the SSI module. Then they complete post and follow-up questionnaires.
Child Anxiety Impact Scale - Child Version at Follow Up	18 units on a scale Standard Deviation 12	16 units on a scale Standard Deviation 14

SECONDARY outcome

Timeframe: first session at baseline

Parent-report measure of the frequency with which parents participate in their child's anxiety-related behaviors (e.g., assisting avoidance, providing reassurance) and modification of family routines because of child anxiety over the past month. The name of the measure is the Family Accommodation Scale Anxiety - Parent Version (FASA-P). The FASA-P is a measure of parental accommodation. Total scores on the FASA-C range from 0 to 36, with higher scores representing more parental accommodation.

Outcome measures

Measure	Waitlist Control n=29 Participants Participants complete pre, post, and follow-up questionnaires. They have the option to view the SSI module after completing follow-up questionnaires.	Single Session Intervention Receivers n=30 Participants Participants complete pre then receive the SSI module. Then they complete post and follow-up questionnaires.
Family Accommodation Scale Anxiety - Parent Version at Pre	15 units on a scale Standard Deviation 8	13 units on a scale Standard Deviation 8

SECONDARY outcome

Timeframe: first session at baseline

Youth-report measure of the frequency with which parents participate in their child's anxiety-related behaviors (e.g., assisting avoidance, providing reassurance) and modification of family routines because of child anxiety over the past month. The name of the measure is the Family Accommodation Scale Anxiety - Child Version (FASA-C). The FASA-C is a measure of parental accommodation. Total scores on the FASA-C range from 0 to 36, with higher scores representing more parental accommodation.

Outcome measures

Measure	Waitlist Control n=29 Participants Participants complete pre, post, and follow-up questionnaires. They have the option to view the SSI module after completing follow-up questionnaires.	Single Session Intervention Receivers n=30 Participants Participants complete pre then receive the SSI module. Then they complete post and follow-up questionnaires.
Family Accommodation Scale Anxiety - Child Version at Pre	15 units on a scale Standard Deviation 6	14 units on a scale Standard Deviation 7

SECONDARY outcome

Timeframe: 1 week after first session

Parent-report measure of the frequency with which parents participate in their child's anxiety-related behaviors (e.g., assisting avoidance, providing reassurance) and modification of family routines because of child anxiety over the past week. The name of the measure is the Family Accommodation Scale Anxiety - Parent Version (FASA-P). The FASA-P is a measure of parental accommodation. Total scores on the FASA-C range from 0 to 36, with higher scores representing more parental accommodation.

Outcome measures

Measure	Waitlist Control n=29 Participants Participants complete pre, post, and follow-up questionnaires. They have the option to view the SSI module after completing follow-up questionnaires.	Single Session Intervention Receivers n=30 Participants Participants complete pre then receive the SSI module. Then they complete post and follow-up questionnaires.
Family Accommodation Scale Anxiety - Parent Version at Posttreatment	14 units on a scale Standard Deviation 8	11 units on a scale Standard Deviation 8

SECONDARY outcome

Timeframe: 1 week after first session

Youth-report measure of the frequency with which parents participate in their child's anxiety-related behaviors (e.g., assisting avoidance, providing reassurance) and modification of family routines because of child anxiety over the past week. The name of the measure is the Family Accommodation Scale Anxiety - Child Version (FASA-C). The FASA-C is a measure of parental accommodation. Total scores on the FASA-C range from 0 to 36, with higher scores representing more parental accommodation.

Outcome measures

Measure	Waitlist Control n=29 Participants Participants complete pre, post, and follow-up questionnaires. They have the option to view the SSI module after completing follow-up questionnaires.	Single Session Intervention Receivers n=30 Participants Participants complete pre then receive the SSI module. Then they complete post and follow-up questionnaires.
Family Accommodation Scale Anxiety - Child Version at Posttreatment	11 units on a scale Standard Deviation 7	9 units on a scale Standard Deviation 6

SECONDARY outcome

Timeframe: 4 weeks after first session

Parent-report measure of the frequency with which parents participate in their child's anxiety-related behaviors (e.g., assisting avoidance, providing reassurance) and modification of family routines because of child anxiety over the past 3 weeks. The name of the measure is the Family Accommodation Scale Anxiety - Parent Version (FASA-P). The FASA-P is a measure of parental accommodation. Total scores on the FASA-C range from 0 to 36, with higher scores representing more parental accommodation.

Outcome measures

Measure	Waitlist Control n=29 Participants Participants complete pre, post, and follow-up questionnaires. They have the option to view the SSI module after completing follow-up questionnaires.	Single Session Intervention Receivers n=30 Participants Participants complete pre then receive the SSI module. Then they complete post and follow-up questionnaires.
Family Accommodation Scale Anxiety - Parent Version at Follow Up	14 units on a scale Standard Deviation 9	11 units on a scale Standard Deviation 7

SECONDARY outcome

Timeframe: 4 weeks after first session

Youth-report measure of the frequency with which parents participate in their child's anxiety-related behaviors (e.g., assisting avoidance, providing reassurance) and modification of family routines because of child anxiety over the past 3 weeks. The name of the measure is the Family Accommodation Scale Anxiety - Child Version (FASA-C). The FASA-C is a measure of parental accommodation. Total scores on the FASA-C range from 0 to 36, with higher scores representing more parental accommodation.

Outcome measures

Measure	Waitlist Control n=29 Participants Participants complete pre, post, and follow-up questionnaires. They have the option to view the SSI module after completing follow-up questionnaires.	Single Session Intervention Receivers n=30 Participants Participants complete pre then receive the SSI module. Then they complete post and follow-up questionnaires.
Family Accommodation Scale Anxiety - Child Version at Follow Up	11 units on a scale Standard Deviation 7	8 units on a scale Standard Deviation 6

SECONDARY outcome

Timeframe: 1 week after first session

Parent report measure of consumer satisfaction with services received (e.g., "How would you rate the quality of the services you received?" and "If a friend were in need of similar help, would you recommend our program to him or her?"). The name of the measure is Client Satisfaction Questionnaire (CSQ-8). Total scores on the CSQ-8 range from 8 to 32, with higher scores representing more satisfaction with services received.

Outcome measures

Measure	Waitlist Control n=30 Participants Participants complete pre, post, and follow-up questionnaires. They have the option to view the SSI module after completing follow-up questionnaires.	Single Session Intervention Receivers Participants complete pre then receive the SSI module. Then they complete post and follow-up questionnaires.
Client Satisfaction Questionnaire - Parent Report at Posttreatment	29 units on a scale Standard Deviation 3	—

SECONDARY outcome

Timeframe: 1 week after first session

Youth-report measure of consumer satisfaction with services received (e.g., "How would you rate the quality of the services you received?" and "If a friend were in need of similar help, would you recommend our program to him or her?"). The name of the measure is Client Satisfaction Questionnaire (CSQ-8). Total scores on the CSQ-8 range from 8 to 32, with higher scores representing more satisfaction with services received.

Outcome measures

Measure	Waitlist Control n=30 Participants Participants complete pre, post, and follow-up questionnaires. They have the option to view the SSI module after completing follow-up questionnaires.	Single Session Intervention Receivers Participants complete pre then receive the SSI module. Then they complete post and follow-up questionnaires.
Client Satisfaction Questionnaire - Youth Report at Posttreatment	29 units on a scale Standard Deviation 2	—

SECONDARY outcome

Timeframe: 1 week after first session

Parent-report measure of perceived acceptability of a single session intervention (e.g. "I enjoyed the program"). The name of the measure is the Program Feedback Scale (PFS). Total scores on the PFS range from 0 to 35, with higher scores representing more acceptability.

Outcome measures

Measure	Waitlist Control n=30 Participants Participants complete pre, post, and follow-up questionnaires. They have the option to view the SSI module after completing follow-up questionnaires.	Single Session Intervention Receivers Participants complete pre then receive the SSI module. Then they complete post and follow-up questionnaires.
Program Feedback Scale - Parent Report	34 units on a scale Standard Deviation 2	—

SECONDARY outcome

Timeframe: 1 week after first session

Youth-report measure of perceived acceptability of a single session intervention (e.g. "I enjoyed the program"). The name of the measure is the Program Feedback Scale (PFS). Total scores on the PFS range from 0 to 35, with higher scores representing more acceptability.

Outcome measures

Measure	Waitlist Control n=30 Participants Participants complete pre, post, and follow-up questionnaires. They have the option to view the SSI module after completing follow-up questionnaires.	Single Session Intervention Receivers Participants complete pre then receive the SSI module. Then they complete post and follow-up questionnaires.
Program Feedback Scale - Youth Report	29 units on a scale Standard Deviation 5	—

Adverse Events

Waitlist Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Single Session Intervention Receivers

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

Jeremy Pettit

Florida International University

Phone: 3053481671

Email: jpettit@fiu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place