Depression, Emotion Dysregulation, Family Relations, Self Harm, Suicidal Ideation
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALComputer 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.
BEHAVIORALBehavioral: Traditional face-to-face treatment-no technology
Community agencies provide mostly individual counseling but may add some family involvement in treatment planning.
Sponsors
National Institute on Minority Health and Health Disparities (NIMHD)
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
11 Years to 18 Years
Healthy volunteers
Yes
Inclusion criteria
. The adolescent must: * be 11 to 18 years old; * self-report an act of self-harm in the past 6 months, * meet criteria for cut-off on two of the four underlying/maintaining factors (depression, emotion dysregulation, family conflict, substance use), and * live with at least one parent-figure who agrees to participate in assessments and treatment Participants should be willing and able to participate fully in the protocol (e.g., to accept assignment to either condition, to provide sufficient locator information for follow-up, to allow their treatment sessions to be recorded for fidelity/process assessment and supervision).
Exclusion criteria
. Youth who: * have a history of DSM V Developmental Disorders, Elective Mutism, Organic Mental Disorders, Schizophrenia, Delusional Disorder, Psychotic Disorder, and Bipolar Affective Disorder. * are actively in crisis and reporting current ideation with a specific plan and with means to complete the plan.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Columbia Suicide Severity Rating Scale (CSSRS) Suicide Ideation | Baseline, 4 months post baseline, 12 months post baseline | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Reported Self-harm Behavior | Baseline, 4 months post baseline, 12 months post baseline | 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. |
| Emotional Dysregulation Measured by Emotion Regulation Scale -Short Form (DERS) | Baseline, 4 months post baseline, 12 months post baseline | 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. |
| The Patient Health Questionnaire | Baseline, 4 months post baseline, 12 months post baseline | 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. |
| Family Connectedness | Baseline, 4 months post baseline, 12 months post baseline | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
Four families declined to participate after enrollment (consent and intake assessment) and before randomization.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 84 |
| 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. | 84 |
| Total | 168 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 4 Month Assessment (Post Treatment) | Lost to Follow-up | 8 | 30 |
| Assessment (12-month Post Baseline) | Lost to Follow-up | 12 | 46 |
Baseline characteristics
| Characteristic | Computer Assisted CIFFTA | Behavioral: Traditional Face-to-face Treatment-no Technology | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 42 Participants | 42 Participants | 84 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 42 Participants | 42 Participants | 84 Participants |
| Ethnicity (NIH/OMB) Adolescent Hispanic or Latino | 36 Participants | 37 Participants | 73 Participants |
| Ethnicity (NIH/OMB) Adolescent Not Hispanic or Latino | 3 Participants | 2 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Adolescent Unknown or Not Reported | 3 Participants | 3 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Caregiver Hispanic or Latino | 38 Participants | 40 Participants | 78 Participants |
| Ethnicity (NIH/OMB) Caregiver Not Hispanic or Latino | 4 Participants | 2 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Caregiver Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Adolescent American Indian or Alaska Native | 4 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) Adolescent Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Adolescent Black or African American | 1 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) Adolescent More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Adolescent Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Adolescent Unknown or Not Reported | 12 Participants | 11 Participants | 23 Participants |
| Race (NIH/OMB) Adolescent White | 25 Participants | 26 Participants | 51 Participants |
| Race (NIH/OMB) Caregiver American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Caregiver Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Caregiver Black or African American | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Caregiver More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Caregiver Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Caregiver Unknown or Not Reported | 32 Participants | 35 Participants | 67 Participants |
| Race (NIH/OMB) Caregiver White | 8 Participants | 7 Participants | 15 Participants |
| Sex/Gender, Customized Adolescent Female | 38 Participants | 34 Participants | 72 Participants |
| Sex/Gender, Customized Adolescent Intersex | 0 Participants | 1 Participants | 1 Participants |
| Sex/Gender, Customized Adolescent Male | 4 Participants | 6 Participants | 10 Participants |
| Sex/Gender, Customized Adolescent Unknown | 0 Participants | 1 Participants | 1 Participants |
| Sex/Gender, Customized Caregiver Female | 39 Participants | 37 Participants | 76 Participants |
| Sex/Gender, Customized Caregiver Intersex | 0 Participants | 0 Participants | 0 Participants |
| Sex/Gender, Customized Caregiver Male | 3 Participants | 5 Participants | 8 Participants |
| Sex/Gender, Customized Caregiver Unknown | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 42 | 0 / 42 |
| other Total, other adverse events | 0 / 42 | 0 / 42 |
| serious Total, serious adverse events | 0 / 42 | 0 / 42 |
Outcome results
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.
Time frame: Baseline, 4 months post baseline, 12 months post baseline
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Computer Assisted CIFFTA | Columbia Suicide Severity Rating Scale (CSSRS) Suicide Ideation | Baseline | 20 Participants |
| Computer Assisted CIFFTA | Columbia Suicide Severity Rating Scale (CSSRS) Suicide Ideation | 4-month assessment (post-treatment) | 16 Participants |
| Computer Assisted CIFFTA | Columbia Suicide Severity Rating Scale (CSSRS) Suicide Ideation | 12-month assessment (12 months post baseline) | 6 Participants |
| Behavioral: Traditional Face-to-face Treatment-no Technology | Columbia Suicide Severity Rating Scale (CSSRS) Suicide Ideation | 12-month assessment (12 months post baseline) | 4 Participants |
| Behavioral: Traditional Face-to-face Treatment-no Technology | Columbia Suicide Severity Rating Scale (CSSRS) Suicide Ideation | Baseline | 13 Participants |
| Behavioral: Traditional Face-to-face Treatment-no Technology | Columbia Suicide Severity Rating Scale (CSSRS) Suicide Ideation | 4-month assessment (post-treatment) | 8 Participants |
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.
Time frame: Baseline, 4 months post baseline, 12 months post baseline
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Computer Assisted CIFFTA | Emotional Dysregulation Measured by Emotion Regulation Scale -Short Form (DERS) | Baseline | 3.1 score on a scale | Standard Deviation 0.75 |
| Computer Assisted CIFFTA | Emotional Dysregulation Measured by Emotion Regulation Scale -Short Form (DERS) | 4-month assessment (post-treatment) | 2.8 score on a scale | Standard Deviation 0.59 |
| Computer Assisted CIFFTA | Emotional Dysregulation Measured by Emotion Regulation Scale -Short Form (DERS) | 12-month assessment post baseline | 2.6 score on a scale | Standard Deviation 0.76 |
| Behavioral: Traditional Face-to-face Treatment-no Technology | Emotional Dysregulation Measured by Emotion Regulation Scale -Short Form (DERS) | Baseline | 3.2 score on a scale | Standard Deviation 0.78 |
| Behavioral: Traditional Face-to-face Treatment-no Technology | Emotional Dysregulation Measured by Emotion Regulation Scale -Short Form (DERS) | 4-month assessment (post-treatment) | 2.9 score on a scale | Standard Deviation 0.78 |
| Behavioral: Traditional Face-to-face Treatment-no Technology | Emotional Dysregulation Measured by Emotion Regulation Scale -Short Form (DERS) | 12-month assessment post baseline | 2.8 score on a scale | Standard Deviation 0.71 |
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.
Time frame: Baseline, 4 months post baseline, 12 months post baseline
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Computer Assisted CIFFTA | Family Connectedness | Baseline | 32.1 score on a scale | Standard Deviation 9.3 |
| Computer Assisted CIFFTA | Family Connectedness | 4-month assessment (post treatment) | 33.4 score on a scale | Standard Deviation 8.8 |
| Computer Assisted CIFFTA | Family Connectedness | 12-month assessment (12 months post baseline) | 32.1 score on a scale | Standard Deviation 11.3 |
| Behavioral: Traditional Face-to-face Treatment-no Technology | Family Connectedness | Baseline | 28.4 score on a scale | Standard Deviation 10.5 |
| Behavioral: Traditional Face-to-face Treatment-no Technology | Family Connectedness | 4-month assessment (post treatment) | 31.4 score on a scale | Standard Deviation 10.6 |
| Behavioral: Traditional Face-to-face Treatment-no Technology | Family Connectedness | 12-month assessment (12 months post baseline) | 30.2 score on a scale | Standard Deviation 9.5 |
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.
Time frame: Baseline, 4 months post baseline, 12 months post baseline
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Computer Assisted CIFFTA | Number of Participants Who Reported Self-harm Behavior | Baseline | 25 Participants |
| Computer Assisted CIFFTA | Number of Participants Who Reported Self-harm Behavior | 4- month assessment (post treatment assessment) | 14 Participants |
| Computer Assisted CIFFTA | Number of Participants Who Reported Self-harm Behavior | 12 months assessment (12 months post baseline) | 4 Participants |
| Behavioral: Traditional Face-to-face Treatment-no Technology | Number of Participants Who Reported Self-harm Behavior | Baseline | 18 Participants |
| Behavioral: Traditional Face-to-face Treatment-no Technology | Number of Participants Who Reported Self-harm Behavior | 4- month assessment (post treatment assessment) | 11 Participants |
| Behavioral: Traditional Face-to-face Treatment-no Technology | Number of Participants Who Reported Self-harm Behavior | 12 months assessment (12 months post baseline) | 4 Participants |
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.
Time frame: Baseline, 4 months post baseline, 12 months post baseline
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Computer Assisted CIFFTA | The Patient Health Questionnaire | Baseline | 13.9 score on a scale | Standard Deviation 6.3 |
| Computer Assisted CIFFTA | The Patient Health Questionnaire | 4-month assessment (post treatment) | 10.8 score on a scale | Standard Deviation 5.8 |
| Computer Assisted CIFFTA | The Patient Health Questionnaire | 12-month assessment (12 months post baseline) | 8.9 score on a scale | Standard Deviation 6.7 |
| Behavioral: Traditional Face-to-face Treatment-no Technology | The Patient Health Questionnaire | Baseline | 14.9 score on a scale | Standard Deviation 7 |
| Behavioral: Traditional Face-to-face Treatment-no Technology | The Patient Health Questionnaire | 4-month assessment (post treatment) | 11.6 score on a scale | Standard Deviation 7.7 |
| Behavioral: Traditional Face-to-face Treatment-no Technology | The Patient Health Questionnaire | 12-month assessment (12 months post baseline) | 10.9 score on a scale | Standard Deviation 7.7 |