RightFit
Not yet recruitingNot applicable

Feasibility, Acceptability, and Preliminary Effectiveness of Cognitive Behavioral Therapy for Depression in Autistic Youth in Clinical Settings

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
11 Years to 17 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires, Interviews

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants will: * Complete baseline, mid-treatment, post-treatment, and 3-month follow-up assessments (surveys and interviews) * Be randomly assigned to receive either 12 weeks of CBT-DAY or treatment-as-usual * Participate in therapy sessions during the 12-week intervention period * Complete follow-up assessments three months after treatment to evaluate longer-term outcomes"
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests CBT-DAY, a talk therapy for depression, in autistic youth ages 11–17 who get care without staying in a hospital. Researchers will compare 12 weeks of CBT-DAY with usual care to see which helps more with depression, emotional reactions, self-esteem, and understanding their autism.

The goal of this clinical trial is to learn if Cognitive Behavioral Therapy for Depression in Autistic Youth (CBT-DAY) can improve depressive symptoms and related mechanisms in autistic youth aged 11-17 years with depression receiving care in outpatient clinical settings. The main questions it aims to answer are: * Does CBT-DAY lead to greater reductions in depressive symptom severity compared to treatment-as-usual (TAU)? * Does CBT-DAY improve key mechanisms (emotional reactivity, self-esteem, and autism self-knowledge) associated with depression outcomes? Researchers will compare CBT-DAY versus treatment-as-usual (TAU) to see if CBT-DAY results in greater improvements in depressive symptoms and related outcomes. Participants will: * Complete baseline, mid-treatment, post-treatment, and 3-month follow-up assessments (surveys and interviews) * Be randomly assigned to receive either 12 weeks of CBT-DAY or treatment-as-usual * Participate in therapy sessions during the 12-week intervention period * Complete follow-up assessments three months after treatment to evaluate longer-term outcomes

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Youth must be ages 11–17 and have an autism diagnosis in their medical records.
  • Youth must read at a fifth-grade level or higher and speak in full sentences during sessions.
  • Youth must have high depression symptoms on the first study survey. The study team must agree that depression is a current concern and the treatment is a good fit.
  • Youth must qualify for services at CHLA.
  • If youth take medicine for mental health, it must have stayed the same for at least 8 weeks before the first study visit.
  • At least one parent or caregiver must be willing and able to take part.
  • The participating adult must be at least 18, be the youth’s parent or legal guardian, and be able to give informed consent, meaning they understand and agree to the study.
  • The parent or guardian must be comfortable reading, writing, or speaking English or Spanish and willing to do study activities.

Who can't join

  • Youth have ever been diagnosed with bipolar disorder, which causes major mood shifts; a psychotic disorder, which affects what feels real; or an intellectual disability, which limits learning and daily life skills.
  • Youth have severe thoughts of suicide or harming others, or self-harm that needs more intensive care right away.
  • Youth are currently getting talk therapy for depression.
  • Youth change their mental health medicines during the study; they may be removed from the study.
  • Youth read below a fifth-grade level or cannot speak in full sentences during sessions.
  • The adult is not the youth’s parent or legal guardian, or cannot understand and agree to the study.
  • The parent or guardian is not comfortable reading, writing, or speaking English or Spanish.
  • The parent or guardian is not willing to do study activities.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: Autistic youth: * Age 11 to 17 years * Prior clinical diagnosis of autism (per record review) * At least a fifth grade reading level * An ability to engage in sessions verbally (i.e., full length sentences) * Elevated symptoms of depression at baseline (RCADS) * Depression is a current clinical concern and participant is appropriate for intervention (per investigator determination) * At least one parent/caregiver willing and able to participate * Eligible to receive services at CHLA * If taking psychotropic medication, regimen must be stable for at least 8 weeks prior to baseline Parents/Caregivers: * Age 18 years or older * Parent or legal guardian of participating youth * Able to provide informed consent * Comfortable reading, writing, or speaking English or Spanish * Willing to participate in study procedures Exclusion Criteria: Autistic youth: * Lifetime diagnosis of bipolar disorder, psychotic disorder, or intellectual disability * Severe suicidal or homicidal ideation or self-injury requiring immediate higher-level care * Currently receiving psychotherapy for depression * Changes in psychotropic medication regimen during study participation (participants may be withdrawn) * A reading level below fifth-grade * An inability to engage in sessions verbally (i.e., nonverbal, minimally verbal) Parents/Caregivers: * Not the parent or legal guardian of the participating youth * Unable to provide informed consent * Not comfortable reading, writing, or speaking English or Spanish * Unwilling to participate in study procedures

Study sites (1)

CA