Trial Outcomes & Findings for LGBTQ-affirmative CBT for Youth (NCT NCT05408858)

NCT ID: NCT05408858

Last Updated: 2024-05-31

Results Overview

Client satisfaction with treatment will be measured through the Client Satisfaction Questionnaire-8 (CSQ-8; Larsen et al., 1979), a well-validated, 8-item self-report questionnaire designed to assess patient/client satisfaction with services received. Both the adolescent self-report and the parent report of child services versions of the CSQ-8 will be used in this study. Items are scored on a 4-point scale, where higher scores indicate more satisfaction. Total score is determined by summing the 8 items, yielding a score between 8 and 32. The CSQ-8 has demonstrated excellent internal consistency in prior studies (alpha = 0.93)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

9 participants

Primary outcome timeframe

Immediate Post-treatment at Week 10

Results posted on

2024-05-31

Participant Flow

The study was advertised to potential participants using social media (Facebook and Twitter). Study team also sent emails to LGBTQ organizations in the Tri-state area to promote the study.

Participant milestones

Participant milestones
Measure
LGBTQ-affirmative Cognitive Behavioral Group Therapy
LGBTQ-affirmative cognitive behavioral group therapy consists of 10 weekly, 90-minute group therapy sessions, delivered remotely via Zoom. Intervention sessions and associated home practice will cover the following topics: Building and keeping motivation; Introduction to LGBTQ-related stress; Getting to know your emotions; Introduction to emotional behaviors and behavioral experiments; Awareness of physical sensations and introduction to flexible thinking; Being flexible in your thinking; Awareness of emotional experiences; Assertiveness; Situational exposures; Reviewing accomplishments and looking ahead. Participants will be taught intervention content through a range of teaching modalities including use of the Zoom whiteboard feature, videos, interactive activities, worksheets, and group discussion. LGBTQ-affirmative cognitive behavioral group therapy: 10 sessions of supportive, LGBTQ-affirmative psychotherapy
Overall Study
STARTED
9
Overall Study
COMPLETED
8
Overall Study
NOT COMPLETED
1

Reasons for withdrawal

Reasons for withdrawal
Measure
LGBTQ-affirmative Cognitive Behavioral Group Therapy
LGBTQ-affirmative cognitive behavioral group therapy consists of 10 weekly, 90-minute group therapy sessions, delivered remotely via Zoom. Intervention sessions and associated home practice will cover the following topics: Building and keeping motivation; Introduction to LGBTQ-related stress; Getting to know your emotions; Introduction to emotional behaviors and behavioral experiments; Awareness of physical sensations and introduction to flexible thinking; Being flexible in your thinking; Awareness of emotional experiences; Assertiveness; Situational exposures; Reviewing accomplishments and looking ahead. Participants will be taught intervention content through a range of teaching modalities including use of the Zoom whiteboard feature, videos, interactive activities, worksheets, and group discussion. LGBTQ-affirmative cognitive behavioral group therapy: 10 sessions of supportive, LGBTQ-affirmative psychotherapy
Overall Study
no longer met eligibility criteria
1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
LGBTQ-affirmative Cognitive Behavioral Group Therapy
n=9 Participants
LGBTQ-affirmative cognitive behavioral group therapy consists of 10 weekly, 90-minute group therapy sessions, delivered remotely via Zoom. Intervention sessions and associated home practice will cover the following topics: Building and keeping motivation; Introduction to LGBTQ-related stress; Getting to know your emotions; Introduction to emotional behaviors and behavioral experiments; Awareness of physical sensations and introduction to flexible thinking; Being flexible in your thinking; Awareness of emotional experiences; Assertiveness; Situational exposures; Reviewing accomplishments and looking ahead. Participants will be taught intervention content through a range of teaching modalities including use of the Zoom whiteboard feature, videos, interactive activities, worksheets, and group discussion. LGBTQ-affirmative cognitive behavioral group therapy: 10 sessions of supportive, LGBTQ-affirmative psychotherapy
Age, Continuous
13.89 years
STANDARD_DEVIATION 1.36 • n=9 Participants
Sex/Gender, Customized
Transgender girl
1 Participants
n=9 Participants
Sex/Gender, Customized
Cisgender girl
2 Participants
n=9 Participants
Sex/Gender, Customized
Transgender boy
1 Participants
n=9 Participants
Sex/Gender, Customized
Nonbinary
3 Participants
n=9 Participants
Sex/Gender, Customized
Nonbinary/questioning
1 Participants
n=9 Participants
Sex/Gender, Customized
Genderfluid
1 Participants
n=9 Participants
Sex: Female, Male
Female
8 Participants
n=9 Participants
Sex: Female, Male
Male
1 Participants
n=9 Participants
Region of Enrollment
United States
9 participants
n=9 Participants
Grade in School
7th
1 Participants
n=9 Participants
Grade in School
8th
1 Participants
n=9 Participants
Grade in School
9th
4 Participants
n=9 Participants
Grade in School
10th
2 Participants
n=9 Participants
Grade in School
11th
1 Participants
n=9 Participants
Sexual Orientation
Lesbian
1 Participants
n=9 Participants
Sexual Orientation
Bisexual
3 Participants
n=9 Participants
Sexual Orientation
Queer
1 Participants
n=9 Participants
Sexual Orientation
Asexual
3 Participants
n=9 Participants
Sexual Orientation
Panromantic asexual
1 Participants
n=9 Participants

PRIMARY outcome

Timeframe: Immediate Post-treatment at Week 10

Population: Only 8 participants were analyzed, as 1 participant was dismissed after session 2 for not meeting eligibility criteria.

Client satisfaction with treatment will be measured through the Client Satisfaction Questionnaire-8 (CSQ-8; Larsen et al., 1979), a well-validated, 8-item self-report questionnaire designed to assess patient/client satisfaction with services received. Both the adolescent self-report and the parent report of child services versions of the CSQ-8 will be used in this study. Items are scored on a 4-point scale, where higher scores indicate more satisfaction. Total score is determined by summing the 8 items, yielding a score between 8 and 32. The CSQ-8 has demonstrated excellent internal consistency in prior studies (alpha = 0.93)

Outcome measures

Outcome measures
Measure
LGBTQ-affirmative Cognitive Behavioral Group Therapy
n=8 Participants
LGBTQ-affirmative cognitive behavioral group therapy consists of 10 weekly, 90-minute group therapy sessions, delivered remotely via Zoom. Intervention sessions and associated home practice will cover the following topics: Building and keeping motivation; Introduction to LGBTQ-related stress; Getting to know your emotions; Introduction to emotional behaviors and behavioral experiments; Awareness of physical sensations and introduction to flexible thinking; Being flexible in your thinking; Awareness of emotional experiences; Assertiveness; Situational exposures; Reviewing accomplishments and looking ahead. Participants will be taught intervention content through a range of teaching modalities including use of the Zoom whiteboard feature, videos, interactive activities, worksheets, and group discussion. LGBTQ-affirmative cognitive behavioral group therapy: 10 sessions of supportive, LGBTQ-affirmative psychotherapy
Client Satisfaction With Treatment
27.13 score on a scale
Standard Deviation 5.22

SECONDARY outcome

Timeframe: Immediate Post-treatment at Week 10

Participant session attendance will be tracked by the study therapist each week to examine the feasibility of weekly sessions. Attendance will be scored as an average of summed weekly attendance counts per participant.

Outcome measures

Outcome measures
Measure
LGBTQ-affirmative Cognitive Behavioral Group Therapy
n=9 Participants
LGBTQ-affirmative cognitive behavioral group therapy consists of 10 weekly, 90-minute group therapy sessions, delivered remotely via Zoom. Intervention sessions and associated home practice will cover the following topics: Building and keeping motivation; Introduction to LGBTQ-related stress; Getting to know your emotions; Introduction to emotional behaviors and behavioral experiments; Awareness of physical sensations and introduction to flexible thinking; Being flexible in your thinking; Awareness of emotional experiences; Assertiveness; Situational exposures; Reviewing accomplishments and looking ahead. Participants will be taught intervention content through a range of teaching modalities including use of the Zoom whiteboard feature, videos, interactive activities, worksheets, and group discussion. LGBTQ-affirmative cognitive behavioral group therapy: 10 sessions of supportive, LGBTQ-affirmative psychotherapy
Session Attendance
7 sessions
Standard Deviation 3.04

Adverse Events

LGBTQ-affirmative Cognitive Behavioral Group Therapy

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. Ilana Seager van Dyk

Massey University

Phone: +64 4 979 3625

Results disclosure agreements

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