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| ID | Type | Description | Link |
|---|---|---|---|
| U54MD002266 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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This study is designed to refine and test the efficacy of a computer assisted culturally informed and flexible/adaptive intervention for Latino adolescents for whom self-harm behaviors are a health disparity-specifically, Latinas and sexual/gender minority youth.
This study enhances an original Computer Assisted Culturally Informed and Flexible Family-Based Treatment for Adolescents (CA CIFFTA) to directly address key targets related to self-harm behavior (e.g., depression, emotion dysregulation, LGBT, culture-related stressors, and trauma-related stressors); (b) refines the technological aspects of CA CIFFTA for web-based delivery; and (c) tests the preliminary efficacy of the new intervention and its delivery system in a randomized trial of 100 Hispanic adolescents and their parents. The investigators seek to reduce risk for repeated self-harm by showing treatment effects on depression, emotion regulation, substance use, and family functioning. Participants are randomly assigned to CA CIFFTA or Treatment-As-Usual and treatment covers a four month period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Computer Assisted CIFFTA | Experimental | CA CIFFTA (Computer Assisted Culturally Informed and Flexible Family Based Treatment for Adolescents) consists of a hybrid intervention utilizing office-based CIFFTA and technology-delivered material. Over 16 weeks CIFFTA participants receive 45 minutes of face-to-face sessions plus approximately 45 minutes of web-based intervention per week. During the continuing care phase participants access website resources and receive targeted messages (e.g., handling family conflicts). CA CIFFTA will: 1) deliver psycho-educational modules (e.g., depression, emotion regulation), 2) collect diary-card information, and 3) provide additional resources. During videos parents and adolescents can report symptoms and information that is automatically transmitted to therapists and used in the next session |
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| Behavioral: Traditional face-to-face treatment-no technology | Active Comparator | Participants randomized to Treatment-As-Usual (TAU) work over a 16-week period with their community agency. They may receive individual or family treatment. The team coordinates with the TAU agencies to minimize the overlap of data collected. The team will refer out to service locations that are most convenient for the participant. A great deal of thought has gone into the selection of the Treatment as Usual condition. The investigators wanted to compare CA CIFFTA's ability to retain and bring about change in participants with what is typically done in the community. Although running an in-house comparison condition gives more control of the delivery of services and tracking of clients, it is difficult to know how that compared to the services that are typically provided in the community |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computer Assisted CIFFTA | Behavioral | This is a hybrid intervention that includes individual work with the adolescent (e.g., Motivational Interviewing, diary card identification of triggers), computer assisted psychoeducational work, and intensive family therapy interventions. |
| Measure | Description | Time Frame |
|---|---|---|
| Columbia Suicide Severity Rating Scale (CSSRS) Suicide Ideation | The Columbia yields information on suicide ideation and Ideation with Intent. Youth were categorized as having or not having ideation and having or not having intent to suicide (yes/no). Endorsing any of these items as "yes" is a worse outcome. The number listed below is the number of participants that said "yes" to experiencing suicidal ideation in the last month. | Baseline, 4 months post baseline, 12 months post baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Reported Self-harm Behavior | The Deliberate Self-harm Inventory Youth Version (DSHI-Y) documents self-harm behavior. The data collected focused on the number of participants who reported "yes" to having engaged in self-harm in the past 30 days. | Baseline, 4 months post baseline, 12 months post baseline |
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Inclusion Criteria. The adolescent must:
Exclusion Criteria. Youth who:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Santisteban, Ph.D. | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute for Individual and Family Counseling | Coral Gables | Florida | 33146 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33677832 | Derived | Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Interventions for self-harm in children and adolescents. Cochrane Database Syst Rev. 2021 Mar 7;3(3):CD013667. doi: 10.1002/14651858.CD013667.pub2. |
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Four families declined to participate after enrollment (consent and intake assessment) and before randomization.
For each family, an adolescent and a caregiver were consented and participated in the study. 42 adolescents and their caregivers were randomized in each arm and received intervention. However, for the outcome measures section, only the adolescent's data was collected and reported for the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Computer Assisted CIFFTA | CA CIFFTA (Computer Assisted Culturally Informed and Flexible Family Based Treatment for Adolescents) consists of a hybrid intervention utilizing office-based CIFFTA and technology-delivered material. Over 16 weeks CIFFTA participants receive 45 minutes of face-to-face sessions plus approximately 45 minutes of web-based intervention per week. During the continuing care phase participants access website resources and receive targeted messages (e.g., handling family conflicts). CA CIFFTA will: 1) deliver psycho-educational modules (e.g., depression, emotion regulation), 2) collect diary-card information, and 3) provide additional resources. During videos parents and adolescents can report symptoms and information that is automatically transmitted to therapists and used in the next session Computer Assisted CIFFTA: This is a hybrid intervention that includes individual work with the adolescent (e.g., Motivational Interviewing, diary card identification of triggers), computer assisted psychoeducational work, and intensive family therapy interventions. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Baseline |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 3, 2022 | Oct 9, 2024 |
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Randomization will be stratified by gender, type of self-harm, trauma exposure and LGBT status. The investigators will attempt to match overall contact hours (in the experimental condition some of these hours will be with technology). During the "continuing care" phase the CIFFTA families will interact with the therapist via the website for a period of 8 additional weeks. To match dosage time during aftercare, Treatment As Usual (TAU) will receive "check-in" telephone calls with the therapist.
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| Behavioral: Traditional face-to-face treatment-no technology | Behavioral | Community agencies provide mostly individual counseling but may add some family involvement in treatment planning. |
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| Emotional Dysregulation Measured by Emotion Regulation Scale -Short Form (DERS) |
Difficulties with Emotion Regulation Scale -Short form (DERS), is designed to assess emotional dysregulation using a 5-point Likert Scale. The total score is calculated from the sum of all items, with higher scores indicating greater problems with emotion regulation. Total summed scores can range from 18 - 90 but investigators report that average item score (1-5) rather than the sum so that is more easily interpretable in the 5 point Likert Scale. |
| Baseline, 4 months post baseline, 12 months post baseline |
| The Patient Health Questionnaire | The PHQ-9 incorporates the DSM-IV depression diagnostic criteria with other leading major depressive symptoms into a brief self-report tool. Depression Severity: 0 - none, 1-4 minimal, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe. | Baseline, 4 months post baseline, 12 months post baseline |
| Family Connectedness | The Family Connectedness (FC) scale includes seven items assessing communication and the relationship between parents and youth. A composite score was obtained. Two items measured communication and five items measured connectedness. The five Items were scored on a 1-10 scale and summed to a total connectedness score. Minimum score = 5 and Maximum score = 50. Higher scores mean better connections. | Baseline, 4 months post baseline, 12 months post baseline |
| FG001 | Behavioral: Traditional Face-to-face Treatment-no Technology | Participants randomized to Treatment-As-Usual (TAU) work over a 16-week period with their community agency. They may receive individual or family treatment. The team coordinates with the TAU agencies to minimize the overlap of data collected. The team will refer out to service locations that are most convenient for the participant. A great deal of thought has gone into the selection of the Treatment as Usual condition. The investigators wanted to compare CA CIFFTA's ability to retain and bring about change in participants with what is typically done in the community. Although running an in-house comparison condition gives more control of the delivery of services and tracking of clients, it is difficult to know how that compared to the services that are typically provided in the community Behavioral: Traditional face-to-face treatment-no technology: Community agencies provide mostly individual counseling but may add some family involvement in treatment planning. |
| Adolescent |
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| Caregiver |
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| COMPLETED |
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| NOT COMPLETED |
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| 4 Month Assessment (Post Treatment) |
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| Assessment (12-month Post Baseline) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Computer Assisted CIFFTA | CA CIFFTA (Computer Assisted Culturally Informed and Flexible Family Based Treatment for Adolescents) consists of a hybrid intervention utilizing office-based CIFFTA and technology-delivered material. Over 16 weeks CIFFTA participants receive 45 minutes of face-to-face sessions plus approximately 45 minutes of web-based intervention per week. During the continuing care phase participants access website resources and receive targeted messages (e.g., handling family conflicts). CA CIFFTA will: 1) deliver psycho-educational modules (e.g., depression, emotion regulation), 2) collect diary-card information, and 3) provide additional resources. During videos parents and adolescents can report symptoms and information that is automatically transmitted to therapists and used in the next session Computer Assisted CIFFTA: This is a hybrid intervention that includes individual work with the adolescent (e.g., Motivational Interviewing, diary card identification of triggers), computer assisted psychoeducational work, and intensive family therapy interventions. |
| BG001 | Behavioral: Traditional Face-to-face Treatment-no Technology | Participants randomized to Treatment-As-Usual (TAU) work over a 16-week period with their community agency. They may receive individual or family treatment. The team coordinates with the TAU agencies to minimize the overlap of data collected. The team will refer out to service locations that are most convenient for the participant. A great deal of thought has gone into the selection of the Treatment as Usual condition. The investigators wanted to compare CA CIFFTA's ability to retain and bring about change in participants with what is typically done in the community. Although running an in-house comparison condition gives more control of the delivery of services and tracking of clients, it is difficult to know how that compared to the services that are typically provided in the community Behavioral: Traditional face-to-face treatment-no technology: Community agencies provide mostly individual counseling but may add some family involvement in treatment planning. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Sex/Gender, Customized | Adolescents and Caregivers reported separately for this analysis | Count of Participants | Participants |
| |||||||||||||||
| Ethnicity (NIH/OMB) | Adolescents and Caregivers reported separately for this analysis | Count of Participants | Participants |
| |||||||||||||||
| Race (NIH/OMB) | Adolescents and Caregivers reported separately for this analysis | Count of Participants | Participants |
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| 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 | Columbia Suicide Severity Rating Scale (CSSRS) Suicide Ideation | The Columbia yields information on suicide ideation and Ideation with Intent. Youth were categorized as having or not having ideation and having or not having intent to suicide (yes/no). Endorsing any of these items as "yes" is a worse outcome. The number listed below is the number of participants that said "yes" to experiencing suicidal ideation in the last month. | Only data from adolescents was collected. Missing data is because they did not provide sufficient item responses to calculate a score. Participants can respond with "don't know" or "refuse". This interferes with scoring. | Posted | Count of Participants | Participants | Baseline, 4 months post baseline, 12 months post baseline |
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| Secondary | Number of Participants Who Reported Self-harm Behavior | The Deliberate Self-harm Inventory Youth Version (DSHI-Y) documents self-harm behavior. The data collected focused on the number of participants who reported "yes" to having engaged in self-harm in the past 30 days. | Only data from adolescents was collected. Missing data is because they did not provide sufficient item responses to calculate a score. Participants can respond with "don't know" or "refuse" and this interferes with scoring. | Posted | Count of Participants | Participants | Baseline, 4 months post baseline, 12 months post baseline |
| |||||||||||||||||||||||||||||||
| Secondary | Emotional Dysregulation Measured by Emotion Regulation Scale -Short Form (DERS) | Difficulties with Emotion Regulation Scale -Short form (DERS), is designed to assess emotional dysregulation using a 5-point Likert Scale. The total score is calculated from the sum of all items, with higher scores indicating greater problems with emotion regulation. Total summed scores can range from 18 - 90 but investigators report that average item score (1-5) rather than the sum so that is more easily interpretable in the 5 point Likert Scale. | Only data from adolescents was collected. Missing data is because they did not provide sufficient item responses to calculate a score. Participants can respond with "don't know" or "refuse". This interferes with scoring. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 4 months post baseline, 12 months post baseline |
| ||||||||||||||||||||||||||||||
| Secondary | The Patient Health Questionnaire | The PHQ-9 incorporates the DSM-IV depression diagnostic criteria with other leading major depressive symptoms into a brief self-report tool. Depression Severity: 0 - none, 1-4 minimal, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe. | Only data from adolescents was collected. Missing data is because they did not provide sufficient item responses to calculate a score. Participants can respond with "don't know" or "refuse". This interferes with scoring. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 4 months post baseline, 12 months post baseline |
| ||||||||||||||||||||||||||||||
| Secondary | Family Connectedness | The Family Connectedness (FC) scale includes seven items assessing communication and the relationship between parents and youth. A composite score was obtained. Two items measured communication and five items measured connectedness. The five Items were scored on a 1-10 scale and summed to a total connectedness score. Minimum score = 5 and Maximum score = 50. Higher scores mean better connections. | Only data from adolescents was collected. Missing data is because they did not provide sufficient item responses to calculate a score. Participants can respond with "don't know" or "refuse". This interferes with scoring. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 4 months post baseline, 12 months post baseline |
|
1 year
Only adolescent data was collected for adverse events.
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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 | Computer Assisted CIFFTA | CA CIFFTA (Computer Assisted Culturally Informed and Flexible Family Based Treatment for Adolescents) consists of a hybrid intervention utilizing office-based CIFFTA and technology-delivered material. Over 16 weeks CIFFTA participants receive 45 minutes of face-to-face sessions plus approximately 45 minutes of web-based intervention per week. During the continuing care phase participants access website resources and receive targeted messages (e.g., handling family conflicts). CA CIFFTA will: 1) deliver psycho-educational modules (e.g., depression, emotion regulation), 2) collect diary-card information, and 3) provide additional resources. During videos parents and adolescents can report symptoms and information that is automatically transmitted to therapists and used in the next session Computer Assisted CIFFTA: This is a hybrid intervention that includes individual work with the adolescent (e.g., Motivational Interviewing, diary card identification of triggers), computer assisted psychoeducational work, and intensive family therapy interventions. | 0 | 42 | 0 | 42 | 0 | 42 |
| EG001 | Behavioral: Traditional Face-to-face Treatment-no Technology | Participants randomized to Treatment-As-Usual (TAU) work over a 16-week period with their community agency. They may receive individual or family treatment. The team coordinates with the TAU agencies to minimize the overlap of data collected. The team will refer out to service locations that are most convenient for the participant. A great deal of thought has gone into the selection of the Treatment as Usual condition. The investigators wanted to compare CA CIFFTA's ability to retain and bring about change in participants with what is typically done in the community. Although running an in-house comparison condition gives more control of the delivery of services and tracking of clients, it is difficult to know how that compared to the services that are typically provided in the community Behavioral: Traditional face-to-face treatment-no technology: Community agencies provide mostly individual counseling but may add some family involvement in treatment planning. | 0 | 42 | 0 | 42 | 0 | 42 |
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The COVID disruptions reduced our overall sample size. A limitation is that we did not collect dosage data on treatment received by TAU participants. Finally, with only two timepoints and a small sample, it was impossible to analyze mediation. The best we could do was to explore plausible mediators (Emotion Regulation and Family Connectedness).
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Victoria Mitrani | University of Miami | 3052849139 | vmitrani@miami.edu |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 21, 2024 | Aug 22, 2024 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 3, 2022 | Aug 17, 2024 | ICF_002.pdf |
| ID | Term |
|---|---|
| D016728 | Self-Injurious Behavior |
| D003863 | Depression |
| D059020 | Suicidal Ideation |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D013405 | Suicide |
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| Between 18 and 65 years |
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| >=65 years |
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| Caregiver |
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| Caregiver |
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| Caregiver |
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| 4-month assessment (post-treatment) |
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| 12-month assessment (12 months post baseline) |
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| OG001 | Behavioral: Traditional Face-to-face Treatment-no Technology | Participants randomized to Treatment-As-Usual (TAU) work over a 16-week period with their community agency. They may receive individual or family treatment. The team coordinates with the TAU agencies to minimize the overlap of data collected. The team will refer out to service locations that are most convenient for the participant. A great deal of thought has gone into the selection of the Treatment as Usual condition. The investigators wanted to compare CA CIFFTA's ability to retain and bring about change in participants with what is typically done in the community. Although running an in-house comparison condition gives more control of the delivery of services and tracking of clients, it is difficult to know how that compared to the services that are typically provided in the community Behavioral: Traditional face-to-face treatment-no technology: Community agencies provide mostly individual counseling but may add some family involvement in treatment planning. |
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| OG001 | Behavioral: Traditional Face-to-face Treatment-no Technology | Participants randomized to Treatment-As-Usual (TAU) work over a 16-week period with their community agency. They may receive individual or family treatment. The team coordinates with the TAU agencies to minimize the overlap of data collected. The team will refer out to service locations that are most convenient for the participant. A great deal of thought has gone into the selection of the Treatment as Usual condition. The investigators wanted to compare CA CIFFTA's ability to retain and bring about change in participants with what is typically done in the community. Although running an in-house comparison condition gives more control of the delivery of services and tracking of clients, it is difficult to know how that compared to the services that are typically provided in the community Behavioral: Traditional face-to-face treatment-no technology: Community agencies provide mostly individual counseling but may add some family involvement in treatment planning. |
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| OG001 | Behavioral: Traditional Face-to-face Treatment-no Technology | Participants randomized to Treatment-As-Usual (TAU) work over a 16-week period with their community agency. They may receive individual or family treatment. The team coordinates with the TAU agencies to minimize the overlap of data collected. The team will refer out to service locations that are most convenient for the participant. A great deal of thought has gone into the selection of the Treatment as Usual condition. The investigators wanted to compare CA CIFFTA's ability to retain and bring about change in participants with what is typically done in the community. Although running an in-house comparison condition gives more control of the delivery of services and tracking of clients, it is difficult to know how that compared to the services that are typically provided in the community Behavioral: Traditional face-to-face treatment-no technology: Community agencies provide mostly individual counseling but may add some family involvement in treatment planning. |
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| OG001 | Behavioral: Traditional Face-to-face Treatment-no Technology | Participants randomized to Treatment-As-Usual (TAU) work over a 16-week period with their community agency. They may receive individual or family treatment. The team coordinates with the TAU agencies to minimize the overlap of data collected. The team will refer out to service locations that are most convenient for the participant. A great deal of thought has gone into the selection of the Treatment as Usual condition. The investigators wanted to compare CA CIFFTA's ability to retain and bring about change in participants with what is typically done in the community. Although running an in-house comparison condition gives more control of the delivery of services and tracking of clients, it is difficult to know how that compared to the services that are typically provided in the community Behavioral: Traditional face-to-face treatment-no technology: Community agencies provide mostly individual counseling but may add some family involvement in treatment planning. |
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