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| ID | Type | Description | Link |
|---|---|---|---|
| R44MH097349 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
| University of Maryland, Baltimore | OTHER |
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The goal of this Phase II Small Business Innovation Research (SBIR) is to develop, evaluate, and commercialize a linked parent-youth mobile app system, VillageWhere, to support the key treatment targets of evidence-based treatments for youth with conduct disorders: clear parental expectations, parental monitoring, discipline consistency, and parental support, while simultaneously cultivating intrinsic motivation in youth toward prosocial behaviors. When used in conjunction with an evidence-based treatment for delinquent youth, VillageWhere could help reduce treatment length and cost. When provided in non-evidence-based clinical settings, VillageWhere may increase access to state-of-the-art clinical techniques to those who might not otherwise receive them. Investigators will conduct usability and acceptability tests of new features with target-end-users (youth and their parents) and key stakeholders (i.e., probation officers, clinic administrators). Once usability and acceptability is achieved, investigators will conduct a 16-week randomized controlled trial (RCT) comparing VillageWhere to an attention-control (placebo) mobile app. We expect that across four time points, VillageWhere use will result in greater improvements in parent management practices and youth autonomy support, parent-youth communication and connectedness, youth intrinsic motivation for positive behavior, and youth conduct problems than the placebo. The RCT will occur with 100 parent-youth dyads recruited from various treatment and probation settings, and represent clinically-significant conduct-problems of various clinically-significant severity levels.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VillageWhere App | Experimental | Parent-youth dyads assigned to the VillageWhere condition will be asked to use the VillageWhere App that has been developed for this study. Parent and youth will be asked upload the app to their phone during the baseline assessment process and asked to use it as often as they would like throughout the duration of the 12 week trial. The app is designed to be used several times throughout each day. |
|
| Attention-Control Placebo App | Placebo Comparator | Parent-youth dyads assigned to the control condition will be asked to use a free placebo control app that is well-liked by parents and youth but void of content already part of an existing evidence-based treatment for youth with conduct problems (e.g., geolocation tracking). Parent and youth will be asked upload the app to their phone during the baseline assessment process and asked to use it as often as they would like throughout the duration of the 12 week trial. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VillageWhere App | Device | VillageWhere is a mobile phone app for use on both Android and iOS platforms by youth with conduct disorders and their parents. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Child Behavior Checklist (CBCL) | Assesses parent report of youth rule-breaking, aggressive, anxious/depressed, and drug/alcohol use behaviors. Contains two subscales: rule-breaking (minimum of 0, maximum of 36) and aggressive behavior (minimum of 0, maximum of 34). Higher scores are a worse outcome. | Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4). |
| Youth Self-Report (YSR) | Assesses youth self-report of rule-breaking, aggressive, anxious/depressed, and drug/alcohol use behaviors. Contains two subscales: rule-breaking (minimum of 0, maximum of 34) and aggressive behavior (minimum of 0, maximum of 36). Higher scores indicate worse outcomes. | Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4). |
| Self-Report of Delinquent Behavior Scale | Assesses youth delinquent behaviors. Contains one main scale: the general delinquency scale. There are also several subscales: the status offenses (e.g., ran away from home, purchased alcohol, truant) subscale, the school delinquency subscale (e.g., cheated on tests, damaged school property, got suspended), the minor theft subscale, and the robbery subscale. For all scales, participants reported the number of times in the past two weeks they did a variety of actions; scales were then calculated as the sum of the occurrences. The minimum of each scale was 0 and there was no maximum, since there is no maximum amount participants could have done the actions listed. | Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4). |
| GAIN Substance Frequency Scale | The Global Appraisal of Individual Needs (GAIN) substance frequency scale assesses youth alcohol and substance use in the last two weeks. Alcohol days are number of days in the past two weeks that youth consumed alcohol. Drunk days are the number of days in the past two weeks that youth were drunk. Marijuana days are number of days in the past two weeks that youth used marijuana. As such, the minimum and maximum values are 0 and 14, respectively, and higher scores mean a worse outcome. |
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Parent Inclusion Criteria:
Parent Exclusion Criteria:
Youth Inclusion Criteria:
Youth Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Linda Dimeff, PhD | Evidence-Based Practice Institute | Principal Investigator |
| Cindy Schaeffer, PhD | University of Maryland, Baltimore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Evidence-Based Practice Institute | Seattle | Washington | 98144 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35640058 | Derived | Schaeffer CM, Dimeff LA, Koerner K, Chung J, Kelley-Brimer A, Kako N, Ilac M, Tuerk E, Carroll D, Beadnell B. A Smartphone App for Parental Management of Adolescent Conduct Problems: Randomized Clinical Trial of iKinnect. J Clin Child Adolesc Psychol. 2025 Jan-Feb;54(1):52-66. doi: 10.1080/15374416.2022.2070851. Epub 2022 May 31. |
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Requests for use of data will be considered on a case-by-case basis. Interested researchers may send data requests to research@ebpi.org.
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We received 645 dyad referrals. 40 were lost to follow-up, meaning 605 dyads completed the initial screen. 354 of those dyads were ineligible. Of the 251 dyads eligible for the study, 142 were lost to follow-up or dropped (mostly for no longer being interested) before consent. 113 dyads were consented, 110 had youth assent obtained, and 108 were randomized to a condition.
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| ID | Title | Description |
|---|---|---|
| FG000 | VillageWhere App | Parent-youth dyads assigned to the VillageWhere condition will be asked to use the VillageWhere App that has been developed for this study. Parent and youth will be asked upload the app to their phone during the baseline assessment process and asked to use it as often as they would like throughout the duration of the 16 week trial. The app is designed to be used several times throughout each day. VillageWhere App: VillageWhere is a mobile phone app for use on both Android and iOS platforms by youth with conduct disorders and their parents. |
| FG001 | Attention-Control Placebo App | Parent-youth dyads assigned to the control condition will be asked to use a free placebo control app that is well-liked by parents and youth but void of content already part of an existing evidence-based treatment for youth with conduct problems (e.g., geolocation tracking). Parent and youth will be asked upload the app to their phone during the baseline assessment process and asked to use it as often as they would like throughout the duration of the 16 week trial. Attention-Control Placebo App: Mobile phone app for use on both Android and iOS platforms. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
55 and 53 are the number of parent/youth dyads assigned to each condition.
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| ID | Title | Description |
|---|---|---|
| BG000 | VillageWhere App | Parent-youth dyads assigned to the VillageWhere condition will be asked to use the VillageWhere App that has been developed for this study. Parent and youth will be asked upload the app to their phone during the baseline assessment process and asked to use it as often as they would like throughout the duration of the 16 week trial. The app is designed to be used several times throughout each day. VillageWhere App: VillageWhere is a mobile phone app for use on both Android and iOS platforms by youth with conduct disorders and their parents. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | The age of the youth participating |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Child Behavior Checklist (CBCL) | Assesses parent report of youth rule-breaking, aggressive, anxious/depressed, and drug/alcohol use behaviors. Contains two subscales: rule-breaking (minimum of 0, maximum of 36) and aggressive behavior (minimum of 0, maximum of 34). Higher scores are a worse outcome. | The number analyzed differs between rows because of attrition over different timepoints. | Posted | Mean | Standard Deviation | score on a scale | Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4). |
|
12 weeks
Participants were asked to report potential and actual adverse events, whether or not the individual considered the event resulting from the research, via online survey, to IRB, or study PI.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | VillageWhere App | Parent-youth dyads assigned to the VillageWhere condition will be asked to use the VillageWhere App that has been developed for this study. Parent and youth will be asked upload the app to their phone during the baseline assessment process and asked to use it as often as they would like throughout the duration of the 16 week trial. The app is designed to be used several times throughout each day. VillageWhere App: VillageWhere is a mobile phone app for use on both Android and iOS platforms by youth with conduct disorders and their parents. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Angela Kelley Brimer | Evidence-Based Practice Institute, Inc. | 253-279-8659 | research@jasprhealth.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 1, 2019 | Mar 16, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 29, 2019 | Mar 16, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D002653 | Child Behavior Disorders |
| ID | Term |
|---|---|
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| Attention-Control Placebo App | Device | Mobile phone app for use on both Android and iOS platforms. |
|
| Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4). |
| Intrinsic Motivation Inventory (IMI) Perceived Competence Scale (PCS) | Assesses youth intrinsic motivation for prosocial behaviors. Contains four subscales: interest/enjoyment (minimum of 7, maximum of 49), perceived competence (minimum of 6, maximum of 42), value/usefulness (minimum of 7, maximum of 49), and effort/importance (minimum of 5, maximum of 35). | Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4). |
| Perceived Autonomy Support (PAS) | Assesses youth perceived autonomy-supportive and controlling parent behaviors. Contains four subscales: autonomy support, chaos, coercion, and structure. Each subscale has a youth version (minimum 4, maximum 16) and a parent version (minimum 5, maximum 20). Higher scores indicate better outcomes on the autonomy and structure scales and worse outcomes on the chaos and coercion scales. | Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4). |
| Perceived Stress Scale (PSS) | Assesses parent perception of life stress. Minimum value is 0, maximum value is 40. Higher scores mean a worse outcome. | Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4). |
| Parent Locus of Control Scale | Assesses parent sense of control/efficacy and supervision of youth. One sub-scale for helplessness and one sub-scale for feeling out of control. Both subscales have a minimum of 10 and maximum of 50. Higher scores are a worse outcome. | Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4). |
| Loeber Parenting Scale | Assesses parent and youth clarity of expectations, discipline consistency/effectiveness, and use of rewards. Subscales are Supervision (minimum of 10 and a maximum of 28 for both the parent and youth scales), Inconsistent Discipline (minimum of 9 and a maximum of 27 for the youth scale, minimum of 5 and maximum of 15 for the parent scales), Reward Use (minimum of 9 and maximum of 27 for both parent and youth scales), and Discipline Effectiveness (minimum of 3 and a maximum of 10 on the parents scale, no youth scale); higher scores mean higher prevalence, lower scores mean infrequency. | Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4). |
| BG001 | Attention-Control Placebo App | Parent-youth dyads assigned to the control condition will be asked to use a free placebo control app that is well-liked by parents and youth but void of content already part of an existing evidence-based treatment for youth with conduct problems (e.g., geolocation tracking). Parent and youth will be asked upload the app to their phone during the baseline assessment process and asked to use it as often as they would like throughout the duration of the 16 week trial. Attention-Control Placebo App: Mobile phone app for use on both Android and iOS platforms. |
| BG002 | Total | Total of all reporting groups |
Some participants have missing data (chose not to input this information).
| Count of Participants |
| Participants |
|
| Age, Categorical | The age of the parents/caregivers participating | Count of Participants | Participants |
|
| Sex: Female, Male | The sex of the youth participating | Some participants have missing data (chose not to input this information). | Count of Participants | Participants |
|
| Sex: Female, Male | The sex of the parents/caregivers participating | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | The race/ethnicity of the parents/caregivers participating | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | The race/ethnicity of the youth participating | Some participants have missing data (chose not to input this information). | Count of Participants | Participants |
|
| Region of Enrollment | The region of the youth participating | Number | participants |
|
| Region of Enrollment | The region of the parents/caregivers participating | Number | participants |
|
| Hispanic (Youth) | Count of Participants | Participants |
|
| Hispanic (Parent) | Count of Participants | Participants |
|
| Arrest (Youth-Only) | Some participants have missing data (chose not to input this information). | Count of Participants | Participants |
|
| Education (Youth) | Some participants have missing data (chose not to input this information). | Count of Participants | Participants |
|
| Education (Parent) | Count of Participants | Participants |
|
| Relationship Status (Parent-only) | Count of Participants | Participants |
|
| Relationship to Teen (Parent-only) | Count of Participants | Participants |
|
| Employment (Parent-only) | Some participants have missing data (chose not to input this information). | Count of Participants | Participants |
|
| Income (Parent-only) | Count of Participants | Participants |
|
| OG001 | Attention-Control Placebo App | Parent-youth dyads assigned to the control condition will be asked to use a free placebo control app that is well-liked by parents and youth but void of content already part of an existing evidence-based treatment for youth with conduct problems (e.g., geolocation tracking). Parent and youth will be asked upload the app to their phone during the baseline assessment process and asked to use it as often as they would like throughout the duration of the 16 week trial. Attention-Control Placebo App: Mobile phone app for use on both Android and iOS platforms. |
|
|
| Primary | Youth Self-Report (YSR) | Assesses youth self-report of rule-breaking, aggressive, anxious/depressed, and drug/alcohol use behaviors. Contains two subscales: rule-breaking (minimum of 0, maximum of 34) and aggressive behavior (minimum of 0, maximum of 36). Higher scores indicate worse outcomes. | The number analyzed differs between rows because of attrition over timepoints. | Posted | Mean | Standard Deviation | score on a scale | Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4). |
|
|
|
| Primary | Self-Report of Delinquent Behavior Scale | Assesses youth delinquent behaviors. Contains one main scale: the general delinquency scale. There are also several subscales: the status offenses (e.g., ran away from home, purchased alcohol, truant) subscale, the school delinquency subscale (e.g., cheated on tests, damaged school property, got suspended), the minor theft subscale, and the robbery subscale. For all scales, participants reported the number of times in the past two weeks they did a variety of actions; scales were then calculated as the sum of the occurrences. The minimum of each scale was 0 and there was no maximum, since there is no maximum amount participants could have done the actions listed. | Number analyzed differs between rows because of attrition over timepoints. | Posted | Mean | Standard Deviation | Occurrences | Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4). |
|
|
|
| Primary | GAIN Substance Frequency Scale | The Global Appraisal of Individual Needs (GAIN) substance frequency scale assesses youth alcohol and substance use in the last two weeks. Alcohol days are number of days in the past two weeks that youth consumed alcohol. Drunk days are the number of days in the past two weeks that youth were drunk. Marijuana days are number of days in the past two weeks that youth used marijuana. As such, the minimum and maximum values are 0 and 14, respectively, and higher scores mean a worse outcome. | Number analyzed differs between rows because of attrition over timepoints. | Posted | Mean | Standard Deviation | Days | Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4). |
|
|
|
| Primary | Intrinsic Motivation Inventory (IMI) Perceived Competence Scale (PCS) | Assesses youth intrinsic motivation for prosocial behaviors. Contains four subscales: interest/enjoyment (minimum of 7, maximum of 49), perceived competence (minimum of 6, maximum of 42), value/usefulness (minimum of 7, maximum of 49), and effort/importance (minimum of 5, maximum of 35). | Number analyzed differs between rows because of attrition over timepoints. | Posted | Mean | Standard Deviation | score on a scale | Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4). |
|
|
|
| Primary | Perceived Autonomy Support (PAS) | Assesses youth perceived autonomy-supportive and controlling parent behaviors. Contains four subscales: autonomy support, chaos, coercion, and structure. Each subscale has a youth version (minimum 4, maximum 16) and a parent version (minimum 5, maximum 20). Higher scores indicate better outcomes on the autonomy and structure scales and worse outcomes on the chaos and coercion scales. | Number analyzed in rows differs from overall number analyzed because of separation of youth and parent subscales and attrition over timepoints. | Posted | Mean | Standard Deviation | score on a scale | Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4). |
|
|
|
| Primary | Perceived Stress Scale (PSS) | Assesses parent perception of life stress. Minimum value is 0, maximum value is 40. Higher scores mean a worse outcome. | The number analyzed differs in the rows because of attrition over time points. | Posted | Mean | Standard Deviation | score on a scale | Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4). |
|
|
|
| Primary | Parent Locus of Control Scale | Assesses parent sense of control/efficacy and supervision of youth. One sub-scale for helplessness and one sub-scale for feeling out of control. Both subscales have a minimum of 10 and maximum of 50. Higher scores are a worse outcome. | Number analyzed in certain rows differs from overall number analyzed because of attrition over timepoints. | Posted | Mean | Standard Deviation | score on a scale | Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4). |
|
|
|
| Primary | Loeber Parenting Scale | Assesses parent and youth clarity of expectations, discipline consistency/effectiveness, and use of rewards. Subscales are Supervision (minimum of 10 and a maximum of 28 for both the parent and youth scales), Inconsistent Discipline (minimum of 9 and a maximum of 27 for the youth scale, minimum of 5 and maximum of 15 for the parent scales), Reward Use (minimum of 9 and maximum of 27 for both parent and youth scales), and Discipline Effectiveness (minimum of 3 and a maximum of 10 on the parents scale, no youth scale); higher scores mean higher prevalence, lower scores mean infrequency. | The number analyzed differs between rows because of attrition over timepoints. | Posted | Mean | Standard Deviation | score on a scale | Baseline (time 1), 4-week follow-up (time 2), 8-week follow-up (time 3), and 12-week follow-up (time 4). |
|
|
|
| 0 |
| 110 |
| 0 |
| 110 |
| 0 |
| 110 |
| EG001 | Attention-Control Placebo App | Parent-youth dyads assigned to the control condition will be asked to use a free placebo control app that is well-liked by parents and youth but void of content already part of an existing evidence-based treatment for youth with conduct problems (e.g., geolocation tracking). Parent and youth will be asked upload the app to their phone during the baseline assessment process and asked to use it as often as they would like throughout the duration of the 16 week trial. Attention-Control Placebo App: Mobile phone app for use on both Android and iOS platforms. | 0 | 106 | 0 | 106 | 0 | 106 |
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| >=65 years |
|
| Asian |
|
| Black |
|
| White |
|
| Asian |
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| Black |
|
| White |
|
| Completed 8th grade |
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| Completed 9th grade |
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| Completed 10th grade |
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| Completed 11th grade |
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| High school graduate |
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| Completed 5th grade |
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| Completed 10th grade |
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| High school graduate |
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| 2-year college degree |
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| 4-year college degree |
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| 4-year degree + Masters |
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| PhD, MD, or other doctoral degree |
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| Single and living with my partner |
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| Married and living with teens parent |
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| Married and living with someone other than teens parent |
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| Separated or divorced/divorcing from the teens parent |
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| Separated or divorced/divorcing from someone other than the teens parent |
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| Stepparent |
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| Grandparent |
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| Family Member Other Than Parent |
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| Other |
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| $20,001 to $30,000 |
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| $30,001 to $40,000 |
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| $40,001 to $50,000 |
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| $50,001 to $60,000 |
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| $60,000 and above |
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| Rule-Breaking Time 2 |
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| Rule-Breaking Time 3 |
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| Aggressive Behavior Time 1 |
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| Status Offenses Time 1 |
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| Interest/Enjoyment Time 2 |
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| Value/Usefulness Time 1 |
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| Parent Autonomy Time 2 |
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| Helpless Time 2 |
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| Out of Control Time 1 |
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