Treating Adolescents With CBT and OBH

NCT ID: NCT04760938

Last Updated: 2022-02-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2021-12-01

Brief Summary

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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

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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).

Conditions

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Anxiety Disorders Depressive Disorder Substance Use Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers
Within OBH programs, the field guides are unaware of which participants are study participants.

Study Groups

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Outdoor Behavioral Healthcare (OBH)

Adolescent participants will be asked to complete an intervention in either an OBH program (90 days) or a CBT (12 weeks) program. Parent/guardians and adolescent participants will be asked to complete several surveys before and during the program, and up to one year after.

Group Type EXPERIMENTAL

Outdoor Behavioral Healthcare (OBH)

Intervention Type BEHAVIORAL

Participants in this intervention will participate in one of 7 programs that have been accredited by the Outdoor Behavioral Healthcare Council that specializes in 13-17 year old adolescents experiencing behavioral healthcare issues. Each program works in a unique wilderness setting in various United States National Forests and Parks (e.g., Washington, Oregon, New Mexico, Wisconsin, Utah). The average length of stay in an OBH wilderness program is 90 days, which is a total standard care time of 1,056 hours. All of the OBH programs have been accredited by the Association for Experiential Education Accreditation for Outdoor Behavioral Healthcare programs.

Cognitive Behavioral Therapy (CBT)

Adolescent participants will be asked to complete an intervention in either an OBH program (90 days) or a CBT (12 weeks) program. Parent/guardians and adolescent participants will be asked to complete several surveys before and during the program, and up to one year after.

Group Type EXPERIMENTAL

Cognitive Behavioral Therapy (CBT)

Intervention Type BEHAVIORAL

The 12-week treatment period will consist of 15 90-minute sessions that will be administered individually. Homework (including reading assignments) are given to encourage your child to practice the techniques learned during the weekly sessions. The total standard of care time for CBT is 22.5 hours of direct treatment hours not including time spent on homework over these twelve weeks. Those therapists that are selected to deliver treatment for the CBT group will be certified by a nationally recognized CBT organization and licensed to work as a therapist in the state where they are providing treatment. Therapy will be delivered in an outpatient setting or through Telehealth.

Interventions

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Outdoor Behavioral Healthcare (OBH)

Participants in this intervention will participate in one of 7 programs that have been accredited by the Outdoor Behavioral Healthcare Council that specializes in 13-17 year old adolescents experiencing behavioral healthcare issues. Each program works in a unique wilderness setting in various United States National Forests and Parks (e.g., Washington, Oregon, New Mexico, Wisconsin, Utah). The average length of stay in an OBH wilderness program is 90 days, which is a total standard care time of 1,056 hours. All of the OBH programs have been accredited by the Association for Experiential Education Accreditation for Outdoor Behavioral Healthcare programs.

Intervention Type BEHAVIORAL

Cognitive Behavioral Therapy (CBT)

The 12-week treatment period will consist of 15 90-minute sessions that will be administered individually. Homework (including reading assignments) are given to encourage your child to practice the techniques learned during the weekly sessions. The total standard of care time for CBT is 22.5 hours of direct treatment hours not including time spent on homework over these twelve weeks. Those therapists that are selected to deliver treatment for the CBT group will be certified by a nationally recognized CBT organization and licensed to work as a therapist in the state where they are providing treatment. Therapy will be delivered in an outpatient setting or through Telehealth.

Intervention Type BEHAVIORAL

Other Intervention Names

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Wilderness Therapy

Eligibility Criteria

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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)
Minimum Eligible Age

13 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of New Hampshire

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of New Hampshire

Durham, New Hampshire, United States

Site Status

Countries

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United States

Related Links

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https://mypages.unh.edu/unhbehavioralhealthstudy/research

Website for study participants to apply to screening survey and obtain study information

Other Identifiers

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UNH-07-8354-01

Identifier Type: -

Identifier Source: org_study_id

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