An interventional study of Computer Assisted CIFFTA and Behavioral: Traditional face-to-face treatment-no technology in Self Harm, Depression and Emotion Dysregulation, sponsored by University of Miami. Completed at 1 site in United States. Open to participants aged 11 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-05.
Sponsored by University of Miami · Not applicable, Interventional, and Treatment
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.
515 studies on the registry are indexed under Suicidal Ideation; 195 are open to participants now.
This study's enrollment of 172 is above the median of 80 across 426 interventional studies indexed under Suicidal Ideation.
Browse Suicidal Ideation studies →University of Miami is the lead sponsor of 820 studies on the registry; 161 are open to participants now.
Of its 111 completed or terminated interventional studies of FDA-regulated products, 93 (84%) have results posted.
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Exclusion Criteria. Youth who:
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
Behavioral: Computer Assisted CIFFTA
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: Behavioral: Traditional face-to-face treatment-no technology
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.
Also known as: Behavioral: Family Therapy, Behavioral: Individual Therapy, Behavioral: Technology delivered psycho-educational modules
Community agencies provide mostly individual counseling but may add some family involvement in treatment planning.
Also known as: Behavioral: Individual Therapy, Behavioral: Family Therapy
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.
Time frame: Baseline, 4 months post baseline, 12 months post baseline
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.
Time frame: Baseline, 4 months post baseline, 12 months post baseline
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 4 months post baseline, 12 months post baseline
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.
| Milestone | Computer Assisted CIFFTA | Behavioral: Traditional Face-to-face Treatment-no Technology |
|---|---|---|
| Started | 84 | 84 |
| Adolescent | 42 | 42 |
| Caregiver | 42 | 42 |
| Completed | 84 | 84 |
| Not completed | 0 | 0 |
| Milestone | Computer Assisted CIFFTA | Behavioral: Traditional Face-to-face Treatment-no Technology |
|---|---|---|
| Started | 84 | 84 |
| Adolescent | 38 | 27 |
| Caregiver | 38 | 27 |
| Completed | 76 | 54 |
| Not completed | 8 | 30 |
| Withdrew: Lost to follow-up | 8 | 30 |
| Milestone | Computer Assisted CIFFTA | Behavioral: Traditional Face-to-face Treatment-no Technology |
|---|---|---|
| Started | 84 | 84 |
| Adolescent | 36 | 19 |
| Caregiver | 36 | 19 |
| Completed | 72 | 38 |
| Not completed | 12 | 46 |
| Withdrew: Lost to follow-up | 12 | 46 |
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.
| Participants | Computer Assisted CIFFTA | Behavioral: Traditional Face-to-face Treatment-no Technology |
|---|---|---|
| Baseline | 20 | 13 |
| 4-month assessment (post-treatment) | 16 | 8 |
| 12-month assessment (12 months post baseline) | 6 | 4 |
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.
| Participants | Computer Assisted CIFFTA | Behavioral: Traditional Face-to-face Treatment-no Technology |
|---|---|---|
| Baseline | 25 | 18 |
| 4- month assessment (post treatment assessment) | 14 | 11 |
| 12 months assessment (12 months post baseline) | 4 | 4 |
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.
| score on a scale | Computer Assisted CIFFTA | Behavioral: Traditional Face-to-face Treatment-no Technology |
|---|---|---|
| Baseline | 3.1 ± .75 | 3.2 ± .78 |
| 4-month assessment (post-treatment) | 2.8 ± .59 | 2.9 ± .78 |
| 12-month assessment post baseline | 2.6 ± .76 | 2.8 ± .71 |
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.
| score on a scale | Computer Assisted CIFFTA | Behavioral: Traditional Face-to-face Treatment-no Technology |
|---|---|---|
| Baseline | 13.9 ± 6.3 | 14.9 ± 7.0 |
| 4-month assessment (post treatment) | 10.8 ± 5.8 | 11.6 ± 7.7 |
| 12-month assessment (12 months post baseline) | 8.9 ± 6.7 | 10.9 ± 7.7 |
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.
| score on a scale | Computer Assisted CIFFTA | Behavioral: Traditional Face-to-face Treatment-no Technology |
|---|---|---|
| Baseline | 32.1 ± 9.3 | 28.4 ± 10.5 |
| 4-month assessment (post treatment) | 33.4 ± 8.8 | 31.4 ± 10.6 |
| 12-month assessment (12 months post baseline) | 32.1 ± 11.3 | 30.2 ± 9.5 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Computer Assisted CIFFTA | 0/42 (0%) | 0/42 (0%) | 0/42 (0%) |
| Behavioral: Traditional Face-to-face Treatment-no Technology | 0/42 (0%) | 0/42 (0%) | 0/42 (0%) |
| Age, Categorical(Participants) | Computer Assisted CIFFTA | Behavioral: Traditional Face-to-face Treatment-no Technology | Total |
|---|---|---|---|
| <=18 years | 42 | 42 | 84 |
| Between 18 and 65 years | 42 | 42 | 84 |
| >=65 years | 0 | 0 | 0 |
| Sex/Gender, Customized(Participants) | Computer Assisted CIFFTA | Behavioral: Traditional Face-to-face Treatment-no Technology | Total |
|---|---|---|---|
| Adolescent — Female | 38 | 34 | 72 |
| Adolescent — Male | 4 | 6 | 10 |
| Adolescent — Intersex | 0 | 1 | 1 |
| Adolescent — Unknown | 0 | 1 | 1 |
| Caregiver — Female | 39 | 37 | 76 |
| Caregiver — Male | 3 | 5 | 8 |
| Caregiver — Intersex | 0 | 0 | 0 |
| Caregiver — Unknown | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Computer Assisted CIFFTA | Behavioral: Traditional Face-to-face Treatment-no Technology | Total |
|---|---|---|---|
| Adolescent — Hispanic or Latino | 36 | 37 | 73 |
| Adolescent — Not Hispanic or Latino | 3 | 2 | 5 |
| Adolescent — Unknown or Not Reported | 3 | 3 | 6 |
| Caregiver — Hispanic or Latino | 38 | 40 | 78 |
| Caregiver — Not Hispanic or Latino | 4 | 2 | 6 |
| Caregiver — Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Computer Assisted CIFFTA | Behavioral: Traditional Face-to-face Treatment-no Technology | Total |
|---|---|---|---|
| Adolescent — American Indian or Alaska Native | 4 | 1 | 5 |
| Adolescent — Asian | 0 | 1 | 1 |
| Adolescent — Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Adolescent — Black or African American | 1 | 3 | 4 |
| Adolescent — White | 25 | 26 | 51 |
| Adolescent — More than one race | 0 | 0 | 0 |
| Adolescent — Unknown or Not Reported | 12 | 11 | 23 |
| Caregiver — American Indian or Alaska Native | 0 | 0 | 0 |
| Caregiver — Asian | 0 | 0 | 0 |
| Caregiver — Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Caregiver — Black or African American | 2 | 0 | 2 |
| Caregiver — White | 8 | 7 | 15 |
| Caregiver — More than one race | 0 | 0 | 0 |
| Caregiver — Unknown or Not Reported | 32 | 35 | 67 |
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