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Completed

NCT Number: NCT05408858

LGBTQ-affirmative CBT for Youth

This study will adapt LGBTQ-affirmative cognitive behavior therapy (CBT) - previously only used with adults - for youth aged 12-17 years. This intervention addresses the pathways through which minority stress compromises lesbian, gay, bisexual, transgender, and queer (LGBTQ) young peoples' mental health. The purpose of this study is to determine if the intervention is acceptable and feasible for LGBTQ youth.

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Key information

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr. Pachankis' Lab

New York, 10010, United States

About this study

Lesbian, gay, bisexual, transgender, and queer (LGBTQ) youth experience more mental health problems than their heterosexual and cisgender peers. The purpose of the proposed mixed-methods study is to assess the feasibility, acceptability, and need for refinement of LGBTQ-affirmative cognitive behavior therapy for youth aged 12-17 years in New York, New Jersey, and Connecticut. This study will be the first to adapt the randomized controlled trial tested LGBTQ-affirmative CBT intervention for youth, and the first to deliver it in a virtual group format. Qualitatively, investigators will conduct structured post-treatment interviews to assess the feasibility, acceptability, and refinement of the intervention in this population. Quantitatively, investigators will assess the feasibility and acceptability of the intervention through analysis of indices like number of sessions attended, number of homework assignments completed, weekly treatment satisfaction ratings, and a post-treatment feedback survey. Investigators will also examine changes from pre- to post-treatment in youth's mental health symptoms, minority stress reactions, and emotional regulation and coping difficulties. These pilot data will be used to estimate the sample sizes needed for a future, larger trial of this treatment, as well as areas in which the treatment could be refined.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 12-17 years old
  • Self-identify as LGBTQ (any diverse sexual orientation and/or gender identity)
  • Live in New York, New Jersey, or Connecticut
  • Fluent in English
  • Meet diagnostic criteria for a DSM-5 internalizing disorder (any depressive, anxiety, obsessive-compulsive, or adjustment disorder)
  • Have consistent, weekly access to an Internet-enabled electronic device that allows for video-conferencing
  • Availability to attend 10 weekly 90 minute intervention sessions in summer 2021
  • Access to a quiet, private place for intervention sessions
  • Provision of informed consent from parent/guardian and assent from the youth

Exclusion criteria

  • Evidence of any psychotic or bipolar spectrum diagnosis
  • Active suicidality and/or homicidality (defined as active intent or concrete plan, as opposed to passive ideation) or psychiatric hospitalization within the past 6 months
  • Significant cognitive impairment (as determined by an intellectual disability screener) or significant developmental disorder (if impairing youth's ability to participate in group therapy)
  • Significant behavior disorder (e.g., oppositional defiant disorder, conduct disorder) if impairing youth's ability to participate in group therapy
  • Currently in mental health treatment exceeding one day per month
  • Received any cognitive-behavioral therapy treatment in the past 12 months
  • Unstable psychotropic medications (defined as changes to antidepressant dosage in the past 3 months, or changes to a benzodiazepine dosage in the past month)

Treatment and study plan

LGBTQ-affirmative cognitive behavioral group therapy

Behavioral

10 sessions of supportive, LGBTQ-affirmative psychotherapy

Primary outcomes

  1. Client Satisfaction With Treatment

    Time frame: Immediate Post-treatment at Week 10

    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)

Secondary outcomes

  1. Session Attendance

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Official study title

LGBTQ-affirmative Cognitive Behavioral Group Therapy for Youth: A Pilot Study

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 7, 2022
Registry last updated
May 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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