Anxiety DisordersNCT04760938
Treating Adolescents With CBT and OBH
A study testing Outdoor Behavioral Healthcare (OBH) and Cognitive Behavioral Therapy (CBT) in people with Anxiety Disorders and Depressive Disorder, run by University of New Hampshire at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety Disorders, Depressive Disorder, Substance Use Disorders
- What is being tested?
- Outdoor Behavioral Healthcare (OBH) and Cognitive Behavioral Therapy (CBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2021to 1 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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)
Show all 9Show fewer
- 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
Who cannot join
- Primary Diagnosis of Substance Use Disorder
- Antisocial Personality
- Level 2 or higher Autism Spectrum
- Schizophrenia
- Actively suicidal
- Eating disorders
Show all 15Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of New Hampshire
Durham, New Hampshire, 03824
About this study
Official title: Reweaving the Web: Treating Adolescents With CBT and OBH
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.
Read the 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).
- Being tested
- Outdoor Behavioral Healthcare (OBH), Cognitive Behavioral Therapy (CBT)
- Medical subject headings
- Anxiety Disorders, Depressive Disorder, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Outdoor Behavioral Healthcare (OBH)Behavioural
Also called Wilderness Therapy
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Outdoor Behavioral Healthcare (OBH) | Experimental | 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. Receives: Behavioral: Outdoor Behavioral Healthcare (OBH) |
| Cognitive Behavioral Therapy (CBT) | Experimental | 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. Receives: Behavioral: Cognitive Behavioral Therapy (CBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in statistical and clinical measures on the Youth Outcomes Questionnaire Self-Report (YoQ-SR) at Week 12
The Y-OQ 2.0 has both a parent report global measure of adolescent functioning and an adolescent self-report measure (Y-OQ SR). Both surveys are designed to measure treatment progress for children and adolescents receiving psychological treatment from a parent or caregiver's perspective. Clinical significance is measured by (1) a gain in seven or more points during the clinical trials or (2) a score under 47. The instrument measures overall youth participant functioning that includes six subscales: (a) Intrapersonal Distress, (b) Somatic Symptoms, (c) Interpersonal Relationships, (d) Social Problems, (e) Behavioral Dysfunction, and (f) Critical Items. It is a 64-item parent/guardian report survey designed to assess youth aged 4 to 17 years (Burlingame et al., 2001). Scores for the YoQ-SR range from -16 to +240. The clinical cut-off score is 46. 47 or above represents clinically acute needs.
Measured: Baseline and Week 12
Change from Baseline in statistical and clinical measures on the Revised Child Anxiety and Depression Scale (RCADS) at Week 12
The Revised Child Anxiety and Depression Scale (RCADS) is a 47-item, youth self-report survey with subscales including: separation anxiety disorder, social phobia, generalized anxiety disorder, panic disorder, obsessive compulsive disorder, and low mood (major depressive disorder). It also yields a Total Anxiety Scale (sum of the 5 anxiety subscales) and a Total Internalizing Scale (sum of all 6 subscales). Additionally, The Revised Child Anxiety and Depression Scale - Parent Version (RCADS-P) similarly assesses parent report of youth's symptoms of anxiety and depression across the same six subscales. Scores for the RCADS range from 0 to 141 (47 items on a Likert scale from 0-3). Higher scores signify a worse outcome.
Measured: Baseline and Week 12
Change from Baseline in statistical and clinical measures on the Family Assessment Device (FAD) at Week 12
The Family Assessment Device (FAD) is a self-report measure that adolescents complete the 10 times (baseline, admission, 5 times during treatment, discharge, 6-months and 12-months post-discharge) and parents complete 5 times (baseline, admission, discharge, 6-months and 12-months post-discharge). The measure consists of seven scales including a General Functioning scale which incorporates items from each of the other scales. The remaining six scales assess the six dimensions of the McMaster Model of Family Functioning which include: (1) Problem Solving, (2) Communication, (3) Roles, (4) Affective Responsiveness, (5) Affective Involvement, and (6) Behavior Control. The FAD has 12 questions scored on a Likert scale from 1-4, resulting in a range of scores from 12 to 48. Higher scores indicate a worse outcome. The clinical cut-off score is 2.0. Scores below 2.0 are normal and scores above 2.0 are clinical.
Measured: Baseline and Week 12
Change from Baseline in statistical and clinical measures on the Adolescent Alcohol Relapse Coping Questionnaire (ARCQ) at Week 12
The ARCQ is a measure designed to assess temptation coping responses among adolescents with a history of alcohol and drug abuse. The instrument has three factors that represent coping strategies that adolescents utilize when placed in situations that require resisting substance use: (1) cognitive and behavioral problem-solving strategies, (2) self-critical thinking items, \& (3) abstinence focused cognitive and behavioral coping items that focus on situational demands of a temptation and the negative consequences of alcohol and drug use.
The Adolescent Relapse Coping Questionnaire (ARCQ) has a range of scores from 34 to 250. Higher scores indicate stronger endorsement of the particular construct measured.
Measured: Baseline and Week 12
Secondary outcomes (8)
Change from Baseline in statistical and clinical measures on the Youth Outcomes Questionnaire Self-Report (YoQ-SR) at Week 36
The Y-OQ 2.0 has both a parent report global measure of adolescent functioning and an adolescent self-report measure (Y-OQ SR). Both surveys are designed to measure treatment progress for children and adolescents receiving psychological treatment from a parent or caregiver's perspective. Clinical significance is measured by (1) a gain in seven or more points during the clinical trials or (2) a score under 47. The instrument measures overall youth participant functioning that includes six subscales: (a) Intrapersonal Distress, (b) Somatic Symptoms, (c) Interpersonal Relationships, (d) Social Problems, (e) Behavioral Dysfunction, and (f) Critical Items. It is a 64-item parent/guardian report survey designed to assess youth aged 4 to 17 years (Burlingame et al., 2001). Scores for the YoQ-SR range from -16 to +240. The clinical cut-off score is 46. 47 or above represents clinically acute needs.
Measured: Baseline and Week 36
Change from Baseline in statistical and clinical measures on the Youth Outcomes Questionnaire Self-Report (YoQ-SR) at Week 60
The Y-OQ 2.0 has both a parent report global measure of adolescent functioning and an adolescent self-report measure (Y-OQ SR). Both surveys are designed to measure treatment progress for children and adolescents receiving psychological treatment from a parent or caregiver's perspective. Clinical significance is measured by (1) a gain in seven or more points during the clinical trials or (2) a score under 47. The instrument measures overall youth participant functioning that includes six subscales: (a) Intrapersonal Distress, (b) Somatic Symptoms, (c) Interpersonal Relationships, (d) Social Problems, (e) Behavioral Dysfunction, and (f) Critical Items. It is a 64-item parent/guardian report survey designed to assess youth aged 4 to 17 years (Burlingame et al., 2001). Scores for the YoQ-SR range from -16 to +240. The clinical cut-off score is 46. 47 or above represents clinically acute needs.
Measured: Baseline and Week 60
Change from Baseline in statistical and clinical measures on the Revised Child Anxiety and Depression Scale (RCADS) at Week 36
The Revised Child Anxiety and Depression Scale (RCADS) is a 47-item, youth self-report survey with subscales including: separation anxiety disorder, social phobia, generalized anxiety disorder, panic disorder, obsessive compulsive disorder, and low mood (major depressive disorder). It also yields a Total Anxiety Scale (sum of the 5 anxiety subscales) and a Total Internalizing Scale (sum of all 6 subscales). Additionally, The Revised Child Anxiety and Depression Scale - Parent Version (RCADS-P) similarly assesses parent report of youth's symptoms of anxiety and depression across the same six subscales. Scores for the RCADS range from 0 to 141 (47 items on a Likert scale from 0-3). Higher scores signify a worse outcome.
Measured: Baseline and Week 36
Change from Baseline in statistical and clinical measures on the Revised Child Anxiety and Depression Scale (RCADS) at Week 60
The Revised Child Anxiety and Depression Scale (RCADS) is a 47-item, youth self-report survey with subscales including: separation anxiety disorder, social phobia, generalized anxiety disorder, panic disorder, obsessive compulsive disorder, and low mood (major depressive disorder). It also yields a Total Anxiety Scale (sum of the 5 anxiety subscales) and a Total Internalizing Scale (sum of all 6 subscales). Additionally, The Revised Child Anxiety and Depression Scale - Parent Version (RCADS-P) similarly assesses parent report of youth's symptoms of anxiety and depression across the same six subscales. Scores for the RCADS range from 0 to 141 (47 items on a Likert scale from 0-3). Higher scores signify a worse outcome.
Measured: Baseline and Week 60
Change from Baseline in statistical and clinical measures on the Family Assessment Device (FAD) at Week 36
The Family Assessment Device (FAD) is a self-report measure that adolescents complete the 10 times (baseline, admission, 5 times during treatment, discharge, 6-months and 12-months post-discharge) and parents complete 5 times (baseline, admission, discharge, 6-months and 12-months post-discharge). The measure consists of seven scales including a General Functioning scale which incorporates items from each of the other scales. The remaining six scales assess the six dimensions of the McMaster Model of Family Functioning which include: (1) Problem Solving, (2) Communication, (3) Roles, (4) Affective Responsiveness, (5) Affective Involvement, and (6) Behavior Control. The FAD has 12 questions scored on a Likert scale from 1-4, resulting in a range of scores from 12 to 48. Higher scores indicate a worse outcome. The clinical cut-off score is 2.0. Scores below 2.0 are normal and scores above 2.0 are clinical.
Measured: Baseline and Week 36
Change from Baseline in statistical and clinical measures on the Family Assessment Device (FAD) at Week 60
The Family Assessment Device (FAD) is a self-report measure that adolescents complete the 10 times (baseline, admission, 5 times during treatment, discharge, 6-months and 12-months post-discharge) and parents complete 5 times (baseline, admission, discharge, 6-months and 12-months post-discharge). The measure consists of seven scales including a General Functioning scale which incorporates items from each of the other scales. The remaining six scales assess the six dimensions of the McMaster Model of Family Functioning which include: (1) Problem Solving, (2) Communication, (3) Roles, (4) Affective Responsiveness, (5) Affective Involvement, and (6) Behavior Control. The FAD has 12 questions scored on a Likert scale from 1-4, resulting in a range of scores from 12 to 48. Higher scores indicate a worse outcome. The clinical cut-off score is 2.0. Scores below 2.0 are normal and scores above 2.0 are clinical.
Measured: Baseline and Week 60
Change from Baseline in statistical and clinical measures on the Adolescent Alcohol Relapse Coping Questionnaire (ARCQ) at Week 36
The ARCQ is a measure designed to assess temptation coping responses among adolescents with a history of alcohol and drug abuse. The instrument has three factors that represent coping strategies that adolescents utilize when placed in situations that require resisting substance use: (1) cognitive and behavioral problem-solving strategies, (2) self-critical thinking items, \& (3) abstinence focused cognitive and behavioral coping items that focus on situational demands of a temptation and the negative consequences of alcohol and drug use.
The Adolescent Relapse Coping Questionnaire (ARCQ) has a range of scores from 34 to 250. Higher scores indicate stronger endorsement of the particular construct measured.
Measured: Baseline and Week 36
Change from Baseline in statistical and clinical measures on the Adolescent Alcohol Relapse Coping Questionnaire (ARCQ) at Week 60
The ARCQ is a measure designed to assess temptation coping responses among adolescents with a history of alcohol and drug abuse. The instrument has three factors that represent coping strategies that adolescents utilize when placed in situations that require resisting substance use: (1) cognitive and behavioral problem-solving strategies, (2) self-critical thinking items, \& (3) abstinence focused cognitive and behavioral coping items that focus on situational demands of a temptation and the negative consequences of alcohol and drug use.
The Adolescent Relapse Coping Questionnaire (ARCQ) has a range of scores from 34 to 250. Higher scores indicate stronger endorsement of the particular construct measured.
Measured: Baseline and Week 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start1 Feb 2021
- Primary completion1 Dec 2021
- Study completion1 Dec 2021
Why it stopped: Failure of comparison group to provide adequate comparison and appropriate comparison
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Hampshire
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04760938
- Sponsor's protocol ID
- UNH-07-8354-01
- Status last verified
- Feb 2022
- First submitted
- 15 Feb 2021
- Last updated
- 18 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reweaving the Web: Treating Adolescents With CBT and OBH
- ClinicalTrials.gov ID
- NCT04760938
- Acronym / sponsor ID
- UNH-07-8354-01
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Failure of comparison group to provide adequate comparison and appropriate comparison
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of New HampshireUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 18 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Outdoor Behavioral Healthcare (OBH) | Experimental | Behavioral: 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. |
| Cognitive Behavioral Therapy (CBT) | Experimental | Behavioral: 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. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (15 listed)
- Primary Diagnosis of Substance Use Disorder
- Antisocial Personality
- Level 2 or higher Autism Spectrum
- Schizophrenia
- Actively suicidal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Outdoor Behavioral Healthcare (OBH)Also: Wilderness TherapyParticipants 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. | Behavioural | Outdoor Behavioral Healthcare (OBH) |
| 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. | Behavioural | Cognitive Behavioral Therapy (CBT) |
Primary outcome
Change from Baseline in statistical and clinical measures on the Youth Outcomes Questionnaire Self-Report (YoQ-SR) at Week 12
Time frame: Baseline and Week 12
The Y-OQ 2.0 has both a parent report global measure of adolescent functioning and an adolescent self-report measure (Y-OQ SR). Both surveys are designed to measure treatment progress for children and adolescents receiving psychological treatment from a parent or caregiver's perspective. Clinical significance is measured by (1) a gain in seven or more points during the clinical trials or (2) a score under 47. The instrument measures overall youth participant functioning that includes six subscales: (a) Intrapersonal Distress, (b) Somatic Symptoms, (c) Interpersonal Relationships, (d) Social Problems, (e) Behavioral Dysfunction, and (f) Critical Items. It is a 64-item parent/guardian report survey designed to assess youth aged 4 to 17 years (Burlingame et al., 2001). Scores for the YoQ-SR range from -16 to +240. The clinical cut-off score is 46. 47 or above represents clinically acute needs.
Change from Baseline in statistical and clinical measures on the Revised Child Anxiety and Depression Scale (RCADS) at Week 12
Time frame: Baseline and Week 12
The Revised Child Anxiety and Depression Scale (RCADS) is a 47-item, youth self-report survey with subscales including: separation anxiety disorder, social phobia, generalized anxiety disorder, panic disorder, obsessive compulsive disorder, and low mood (major depressive disorder). It also yields a Total Anxiety Scale (sum of the 5 anxiety subscales) and a Total Internalizing Scale (sum of all 6 subscales). Additionally, The Revised Child Anxiety and Depression Scale - Parent Version (RCADS-P) similarly assesses parent report of youth's symptoms of anxiety and depression across the same six subscales. Scores for the RCADS range from 0 to 141 (47 items on a Likert scale from 0-3). Higher scores signify a worse outcome.
Change from Baseline in statistical and clinical measures on the Family Assessment Device (FAD) at Week 12
Time frame: Baseline and Week 12
The Family Assessment Device (FAD) is a self-report measure that adolescents complete the 10 times (baseline, admission, 5 times during treatment, discharge, 6-months and 12-months post-discharge) and parents complete 5 times (baseline, admission, discharge, 6-months and 12-months post-discharge). The measure consists of seven scales including a General Functioning scale which incorporates items from each of the other scales. The remaining six scales assess the six dimensions of the McMaster Model of Family Functioning which include: (1) Problem Solving, (2) Communication, (3) Roles, (4) Affective Responsiveness, (5) Affective Involvement, and (6) Behavior Control. The FAD has 12 questions scored on a Likert scale from 1-4, resulting in a range of scores from 12 to 48. Higher scores indicate a worse outcome. The clinical cut-off score is 2.0. Scores below 2.0 are normal and scores above 2.0 are clinical.
Change from Baseline in statistical and clinical measures on the Adolescent Alcohol Relapse Coping Questionnaire (ARCQ) at Week 12
Time frame: Baseline and Week 12
The ARCQ is a measure designed to assess temptation coping responses among adolescents with a history of alcohol and drug abuse. The instrument has three factors that represent coping strategies that adolescents utilize when placed in situations that require resisting substance use: (1) cognitive and behavioral problem-solving strategies, (2) self-critical thinking items, \& (3) abstinence focused cognitive and behavioral coping items that focus on situational demands of a temptation and the negative consequences of alcohol and drug use. The Adolescent Relapse Coping Questionnaire (ARCQ) has a range of scores from 34 to 250. Higher scores indicate stronger endorsement of the particular construct measured.
8 secondary outcomes
Change from Baseline in statistical and clinical measures on the Youth Outcomes Questionnaire Self-Report (YoQ-SR) at Week 36
Time frame: Baseline and Week 36
Change from Baseline in statistical and clinical measures on the Youth Outcomes Questionnaire Self-Report (YoQ-SR) at Week 60
Time frame: Baseline and Week 60
Change from Baseline in statistical and clinical measures on the Revised Child Anxiety and Depression Scale (RCADS) at Week 36
Time frame: Baseline and Week 36
Change from Baseline in statistical and clinical measures on the Revised Child Anxiety and Depression Scale (RCADS) at Week 60
Time frame: Baseline and Week 60
Change from Baseline in statistical and clinical measures on the Family Assessment Device (FAD) at Week 36
Time frame: Baseline and Week 36
Change from Baseline in statistical and clinical measures on the Family Assessment Device (FAD) at Week 60
Time frame: Baseline and Week 60
Change from Baseline in statistical and clinical measures on the Adolescent Alcohol Relapse Coping Questionnaire (ARCQ) at Week 36
Time frame: Baseline and Week 36
Change from Baseline in statistical and clinical measures on the Adolescent Alcohol Relapse Coping Questionnaire (ARCQ) at Week 60
Time frame: Baseline and Week 60
Results and safety
The study was stopped early (reason given: Failure of comparison group to provide adequate comparison and appropriate comparison). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2022.
- Website for study participants to apply to screening survey and obtain study informationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Outdoor Behavioral Healthcare (OBH) and Cognitive Behavioral Therapy (CBT) in people with Anxiety Disorders and Depressive Disorder, run by University of New Hampshire at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Failure of comparison group to provide adequate comparison and appropriate comparison). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in statistical and clinical measures on the Youth Outcomes Questionnaire Self-Report (YoQ-SR) at Week 12 (time frame: Baseline and Week 12). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2022.