Clinical trial NCT04760938: Treating Adolescents With CBT and OBH
Official title: Reweaving the Web: Treating Adolescents With CBT and OBH
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Anxiety Disorders
Depressive Disorder
Substance Use Disorders
Lead sponsor: University of New Hampshire
Sponsor class: OTHER
First posted: 2021-02-18
Enrollment: 10
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a multi-center, stratified (\<$47,000 family income, $47,001-$140,000 family income, \>$140,001 family income, with balanced randomization \[1:1\]), partially-blind, parallel-group study conducted in the United States (7 OBH sites and up to 42 CBT therapists).
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine various behavioral, social, and emotional changes that result from engaging in an OBH and CBT treatment program designed for adolescents.

Detailed description: After being informed about the study and potential risks, all study participants, including minors and parent/guardians, giving written informed consent will complete a screening survey. The screening survey will support research staff in determining whether participants meet the inclusionary and exclusionary data, including meeting scores on the Youth Outcome Questionnaire and the Revised Children's Anxiety and Depression Scale. If participants are eligible based on preliminary criteria, they undergo a screening interview. If participants are eligible following the screening interview and complete a second informed consent, minors and parents/guardians, they will be randomized in a partially-blind, parallel-group study conducted in the United States (7 Outdoor Behavioral Healthcare programs and up to 42 CBT-licensed therapists).

Eligibility criteria: Inclusion Criteria:

* Between the ages of 13 and 17 years of age
* 5th grade reading level
* For minors, informed assent
* Parental informed consent and adult consent to participate in the study
* Current diagnosis of Depression and/or Anxiety per parent report, parental interview, and score of 65 on the RCADS. Youth with comorbid diagnoses of these listed diagnoses are eligible
* Current secondary diagnosis of Substance Use Disorder (optional)
* Score greater than a 47 on the YoQ-2.0
* Willingness to participate in all aspects of the treatment programs
* Has the ability to carry a pack that is 1⁄4 their body weight

Exclusion Criteria:

* Primary Diagnosis of Substance Use Disorder
* Antisocial Personality
* Level 2 or higher Autism Spectrum
* Schizophrenia
* Actively suicidal
* Eating disorders
* BMI greater than 34
* Diabetic
* Physical ailments or disabilities limiting person from hiking, camping, backpacking
* Specific medications including Anxiolytics/Benzodiazepines, Opiates, or multiple Antipsychotics and Mood Stabilizers
* Youth who have a positive pregnancy test
* Participation in another treatment or intervention study within one year of beginning the study
* Individuals currently suffering from detoxification as a result of drug use in the last five days. If drug use occurs during this time period, the participant must wait until they have achieved five days of substance free behavior. This is done to prevent contraindications of treatment (e.g., interaction between drugs and the environment)
* Currently practicing violent behaviors to self or others within the past year per Parent Report
* Currently experiencing hallucinations (hearing voices or seeing things that are not there)

Primary outcomes:
measure: Change from Baseline in statistical and clinical measures on the Youth Outcomes Questionnaire Self-Report (YoQ-SR) at Week 12
timeFrame: Baseline and Week 12
measure: Change from Baseline in statistical and clinical measures on the Revised Child Anxiety and Depression Scale (RCADS) at Week 12
timeFrame: Baseline and Week 12
measure: Change from Baseline in statistical and clinical measures on the Family Assessment Device (FAD) at Week 12
timeFrame: Baseline and Week 12
measure: Change from Baseline in statistical and clinical measures on the Adolescent Alcohol Relapse Coping Questionnaire (ARCQ) at Week 12
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Change from Baseline in statistical and clinical measures on the Youth Outcomes Questionnaire Self-Report (YoQ-SR) at Week 36
timeFrame: Baseline and Week 36
measure: Change from Baseline in statistical and clinical measures on the Youth Outcomes Questionnaire Self-Report (YoQ-SR) at Week 60
timeFrame: Baseline and Week 60
measure: Change from Baseline in statistical and clinical measures on the Revised Child Anxiety and Depression Scale (RCADS) at Week 36
timeFrame: Baseline and Week 36
measure: Change from Baseline in statistical and clinical measures on the Revised Child Anxiety and Depression Scale (RCADS) at Week 60
timeFrame: Baseline and Week 60
measure: Change from Baseline in statistical and clinical measures on the Family Assessment Device (FAD) at Week 36
timeFrame: Baseline and Week 36
measure: Change from Baseline in statistical and clinical measures on the Family Assessment Device (FAD) at Week 60
timeFrame: Baseline and Week 60
measure: Change from Baseline in statistical and clinical measures on the Adolescent Alcohol Relapse Coping Questionnaire (ARCQ) at Week 36
timeFrame: Baseline and Week 36
measure: Change from Baseline in statistical and clinical measures on the Adolescent Alcohol Relapse Coping Questionnaire (ARCQ) at Week 60
timeFrame: Baseline and Week 60
Other outcomes:
measure: Explore how youth understand their treatment goals, treatment progress, change process, and potential for long-term change.
timeFrame: Baseline to Week 60
measure: Explore what youth are learning (outcomes), how they are learning (mechanisms), and how they think they will be able to apply their learning outside of the treatment program (transfer).
timeFrame: Baseline to Week 60
Locations:
city: Durham
country: United States
facility: University of New Hampshire
state: New Hampshire
Study officials:
References: