Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DA040756 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to test the relative effectiveness of a Hispanic-specific eHealth intervention, "e-Health Familias Unidas," in preventing and reducing drug use, sexual risk behaviors, and STIs among Hispanic youth in primary care. Families will be recruited through four pediatric primary care settings. Pediatric staff and research team members, including nurse assistants and mental health professionals, will implement eHealth Familias Unidas.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| eHealth Familias Unidas Primary Care | Experimental | eHealth Familias Unidas consists of 12 sessions: eight (12 - 15 minute) "mock" parent sessions in Spanish and four (30 - 45 minute) online family sessions delivered in either Spanish and/or English. |
|
| Treatment as Usual | No Intervention | Participants in this condition will not receive an intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| eHealth Familias Unidas Primary Care | Behavioral | The experimental condition will consist of "eHealth Familias Unidas Primary Care." eHealth Familias Unidas Primary Care is an adaptation of the face-to-face version of Familias Unidas. As with face-to-face Familias Unidas, eHealth Familias Unidas Primary Care aims to prevent drug use, sexual risk behaviors, and STIs by improving family functioning. Similar to face-to-face Familias Unidas, eHealth Familias Unidas is a multi-level intervention that targets risk and protective factors at the multiple systems affecting the youth and youths' family. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Drug Use | Change in drug use will be reported as the episodes of reported drug use for the previous 90 days with questions from Monitoring the Future | Baseline, Baseline to 6 months, baseline to 12 months, baseline to 24 months, baseline to 36 months |
| Change in Unprotected Sexual Behavior | Change in unprotected sexual behavior was reported as endorsement incidence of having had sex without a condom during the previous 90 days using the Sexual Behavior Instrument. Higher values indicate worst outcomes. | Baseline, Baseline to 6 months, baseline to 12 months, baseline to 24 months, baseline to 36 months |
| Change in Incidence of Sexually Transmitted Infection | Sexually transmitted infection incidence (i.e., gonorrhea and chlamydia) will be analyzed via a Polymerase Chain Reaction (PCR) from urine specimens | Baseline, Baseline to 6 months, baseline to 12 months, baseline to 24 months, baseline to 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Family Functioning as Assessed by the Parenting Practices Questionnaire | Change in family functioning will be reported using the Parenting Practices Scale (Tolan et al., 1997). Subscales include positive parenting (9 items, alpha = .78 for adolescents; alpha = .77 for parents) parental involvement( 20 items, alpha = .86 for adolescents; alpha = .85 parents). Responses range from 0 to 4 with higher values indicating better parenting, higher scores indicate more positive outcomes. The mean for each subscale was used to create a sum score. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Guillermo Prado, Ph.D. | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PrimeCare Pediatrics | Hialeah | Florida | 33016 | United States | ||
| Ileana Fuentes Clinic |
Not provided
Not provided
Not provided
Not provided
Not provided
Additional arms were added to include parent enrollments.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | eHealth Familias Unidas Primary Care-Adolescents | eHealth Familias Unidas consists of 12 sessions: eight (12 - 15 minute) "mock" parent sessions in Spanish and four (30 - 45 minute) online family sessions delivered in either Spanish and/or English. eHealth Familias Unidas Primary Care: The experimental condition will consist of "eHealth Familias Unidas Primary Care." eHealth Familias Unidas Primary Care is an adaptation of the face-to-face version of Familias Unidas. As with face-to-face Familias Unidas, eHealth Familias Unidas Primary Care aims to prevent drug use, sexual risk behaviors, and STIs by improving family functioning. Similar to face-to-face Familias Unidas, eHealth Familias Unidas is a multi-level intervention that targets risk and protective factors at the multiple systems affecting the youth and youths' family. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| 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 | Nov 28, 2017 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Baseline, Baseline to 6 months, baseline to 12 months, baseline to 24 months, baseline to 36 months |
| Change in Family Functioning as Assessed by the Parent Relationship With Peer Group | Change in family functioning will be reported using the Parent Relationship with Peer Group. The Parent Relationship with Peer Group is a six item measure with response items ranging from 0 to 24. Higher scores indicate better outcomes.The mean was used to create a sum score. | Baseline, Baseline to 6 months, baseline to 12 months, baseline to 24 months, baseline to 36 months |
| Change in Family Functioning as Assessed by the Parent-Adolescent Communication Scale | Change in family functioning will be reported using the Parent-Adolescent Communication Scale. The Parent-Adolescent Communication Scale is a twenty-item questionnaire with a total score ranging from 20 to 100 with higher scores indicating better communication.The mean was used to create a sum score. | Baseline, Baseline to 6 months, baseline to 12 months, baseline to 24 months, baseline to 36 months |
| Miami |
| Florida |
| 33134 |
| United States |
| Ambulatory Care Center West Pediatrics at Jackson Memorial Hospital | Miami | Florida | 33136 | United States |
| UM Pediatric Mobile Clinic | Miami | Florida | 33136 | United States |
| UM UHealth Pediatrics at the Professional Arts Center | Miami | Florida | 33136 | United States |
| Borinquean Medical Centers | Miami | Florida | 33137 | United States |
| Borinquen Medical Centers | Miami | Florida | 33137 | United States |
| Kidstown Pediatrics | Miami | Florida | 33137 | United States |
| Belkys Bravo Clinic | Miami | Florida | 33145 | United States |
| Castro Pediatrics | Miami | Florida | 33173 | United States |
| University of Miami UHealth Pediatrics at Kendall | Miami | Florida | 33176 | United States |
| S. Florida Pediatric Partners | Miami | Florida | 33196 | United States |
| FG001 | Treatment as Usual-Adolescents | Participants in this condition will not receive an intervention. |
| FG002 | eHealth Familias Unidas Primary Care-Parents | Number of parents enrolled in the study's experimental condition |
| FG003 | Treatment as Usual-Parents | Number of parents enrolled in the study's control condition |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | eHealth Familias Unidas Primary Care - Adolescents | eHealth Familias Unidas consisted of 12 sessions: eight (12 - 15 minute) parent sessions in Spanish and four (30 - 45 minute) online family sessions delivered in either Spanish and/or English. eHealth Familias Unidas Primary Care: The experimental condition consisted of "eHealth Familias Unidas Primary Care." eHealth Familias Unidas Primary Care is an adaptation of the face-to-face version of Familias Unidas. As with face-to-face Familias Unidas, eHealth Familias Unidas Primary Care aims to prevent drug use, sexual risk behaviors, and STIs by improving family functioning. Similar to face-to-face Familias Unidas, eHealth Familias Unidas is a multi-level intervention that targets risk and protective factors at the multiple systems affecting the youth and youths' family. |
| BG001 | Treatment as Usual - Adolescents | Participants in this condition did not receive an intervention. |
| BG002 | eHealth Familias Unidas Primary Care - Parent | eHealth Familias Unidas consisted of 12 sessions: eight (12 - 15 minute) parent sessions in Spanish and four (30 - 45 minute) online family sessions delivered in either Spanish and/or English. eHealth Familias Unidas Primary Care: The experimental condition consisted of "eHealth Familias Unidas Primary Care." eHealth Familias Unidas Primary Care is an adaptation of the face-to-face version of Familias Unidas. As with face-to-face Familias Unidas, eHealth Familias Unidas Primary Care aims to prevent drug use, sexual risk behaviors, and STIs by improving family functioning. Similar to face-to-face Familias Unidas, eHealth Familias Unidas is a multi-level intervention that targets risk and protective factors at the multiple systems affecting the youth and youths' family. |
| BG003 | Treatment as Usual - Parent | Participants in this condition did not receive an intervention. |
| BG004 | 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, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| 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 | Change in Drug Use | Change in drug use will be reported as the episodes of reported drug use for the previous 90 days with questions from Monitoring the Future | The number of participants represent dyads. However, drug use was not analyzed for parents, only for adolescents. Therefore, these analyses include adolescents only. | Posted | Mean | Standard Deviation | Episodes of drug use | Baseline, Baseline to 6 months, baseline to 12 months, baseline to 24 months, baseline to 36 months |
|
|
| |||||||||||||||||||||||||||||||||||
| Primary | Change in Unprotected Sexual Behavior | Change in unprotected sexual behavior was reported as endorsement incidence of having had sex without a condom during the previous 90 days using the Sexual Behavior Instrument. Higher values indicate worst outcomes. | The number of participants represent dyads. However, unprotected sexual behavior was not analyzed for parents, only for adolescents. Therefore, these analyses include adolescents only. | Posted | Mean | Standard Deviation | Episodes of unprotected sexual behavior | Baseline, Baseline to 6 months, baseline to 12 months, baseline to 24 months, baseline to 36 months |
| |||||||||||||||||||||||||||||||||||||
| Primary | Change in Incidence of Sexually Transmitted Infection | Sexually transmitted infection incidence (i.e., gonorrhea and chlamydia) will be analyzed via a Polymerase Chain Reaction (PCR) from urine specimens | Analysis for the incidence of sexually transmitted infection was not conducted because the data were not collected. The data were not collected because we discontinued urine collection early on due to the COVID pandemic and associated shutdowns. | Posted | Baseline, Baseline to 6 months, baseline to 12 months, baseline to 24 months, baseline to 36 months |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Family Functioning as Assessed by the Parenting Practices Questionnaire | Change in family functioning will be reported using the Parenting Practices Scale (Tolan et al., 1997). Subscales include positive parenting (9 items, alpha = .78 for adolescents; alpha = .77 for parents) parental involvement( 20 items, alpha = .86 for adolescents; alpha = .85 parents). Responses range from 0 to 4 with higher values indicating better parenting, higher scores indicate more positive outcomes. The mean for each subscale was used to create a sum score. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Baseline to 6 months, baseline to 12 months, baseline to 24 months, baseline to 36 months |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Family Functioning as Assessed by the Parent Relationship With Peer Group | Change in family functioning will be reported using the Parent Relationship with Peer Group. The Parent Relationship with Peer Group is a six item measure with response items ranging from 0 to 24. Higher scores indicate better outcomes.The mean was used to create a sum score. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Baseline to 6 months, baseline to 12 months, baseline to 24 months, baseline to 36 months |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Family Functioning as Assessed by the Parent-Adolescent Communication Scale | Change in family functioning will be reported using the Parent-Adolescent Communication Scale. The Parent-Adolescent Communication Scale is a twenty-item questionnaire with a total score ranging from 20 to 100 with higher scores indicating better communication.The mean was used to create a sum score. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Baseline to 6 months, baseline to 12 months, baseline to 24 months, baseline to 36 months |
|
3 Years
Adverse events were not monitored for caregivers.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | eHealth Familias Unidas Primary Care | eHealth Familias Unidas Primary Care consists of 12 sessions: eight (12 - 15 minute) "mock" parent sessions in Spanish and four (30 - 45 minute) online family sessions delivered in either Spanish and/or English. eHealth Familias Unidas Primary Care: The experimental condition consisted of "eHealth Familias Unidas Primary Care." eHealth Familias Unidas Primary Care is an adaptation of the face-to-face version of Familias Unidas. As with face-to-face Familias Unidas, eHealth Familias Unidas Primary Care aims to prevent drug use, sexual risk behaviors, and STIs by improving family functioning. Similar to face-to-face Familias Unidas, eHealth Familias Unidas is a multi-level intervention that targets risk and protective factors at the multiple systems affecting the youth and youths' family. | 0 | 225 | 0 | 225 | 0 | 225 |
| EG001 | Treatment as Usual | Participants in this condition will not receive an intervention. | 0 | 231 | 0 | 231 | 0 | 231 |
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Guillermo Prado | University of Miami | 305-284-2002 | gprado@miami.edu |
| Jun 22, 2022 |
| Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 23, 2017 | Jun 22, 2022 | ICF_003.pdf |
| ID | Term |
|---|---|
| D012749 | Sexually Transmitted Diseases |
| ID | Term |
|---|---|
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| 12 months post baseline |
|
| 24 months post baseline |
|
| 36 months post baseline |
|
Participants in this condition did not receive an intervention.
|
|
|
Participants in this condition did not receive an intervention. |
| OG002 | eHealth Familias Unidas Primary Care-Adolescent | eHealth Familias Unidas consists of 12 sessions: eight (12 - 15 minute) "mock" parent sessions in Spanish and four (30 - 45 minute) online family sessions delivered in either Spanish and/or English. eHealth Familias Unidas Primary Care: The experimental condition consisted of "eHealth Familias Unidas Primary Care." eHealth Familias Unidas Primary Care is an adaptation of the face-to-face version of Familias Unidas. As with face-to-face Familias Unidas, eHealth Familias Unidas Primary Care aims to prevent drug use, sexual risk behaviors, and STIs by improving family functioning. Similar to face-to-face Familias Unidas, eHealth Familias Unidas is a multi-level intervention that targets risk and protective factors at the multiple systems affecting the youth and youths' family. |
| OG003 | Treatment as Usual-Adolescent | Participants in this condition did not receive an intervention. |
|
|
| OG002 | eHealth Familias Unidas Primary Care-Adolescent | eHealth Familias Unidas consists of 12 sessions: eight (12 - 15 minute) "mock" parent sessions in Spanish and four (30 - 45 minute) online family sessions delivered in either Spanish and/or English. eHealth Familias Unidas Primary Care: The experimental condition consisted of "eHealth Familias Unidas Primary Care." eHealth Familias Unidas Primary Care is an adaptation of the face-to-face version of Familias Unidas. As with face-to-face Familias Unidas, eHealth Familias Unidas Primary Care aims to prevent drug use, sexual risk behaviors, and STIs by improving family functioning. Similar to face-to-face Familias Unidas, eHealth Familias Unidas is a multi-level intervention that targets risk and protective factors at the multiple systems affecting the youth and youths' family. |
| OG003 | Treatment as Usual-Adolescent | Participants in this condition did not receive an intervention. |
|
|
| OG002 | eHealth Familias Unidas Primary Care-Adolescent | eHealth Familias Unidas consists of 12 sessions: eight (12 - 15 minute) "mock" parent sessions in Spanish and four (30 - 45 minute) online family sessions delivered in either Spanish and/or English. eHealth Familias Unidas Primary Care: The experimental condition consisted of "eHealth Familias Unidas Primary Care." eHealth Familias Unidas Primary Care is an adaptation of the face-to-face version of Familias Unidas. As with face-to-face Familias Unidas, eHealth Familias Unidas Primary Care aims to prevent drug use, sexual risk behaviors, and STIs by improving family functioning. Similar to face-to-face Familias Unidas, eHealth Familias Unidas is a multi-level intervention that targets risk and protective factors at the multiple systems affecting the youth and youths' family. |
| OG003 | Treatment as Usual-Adolescent | Participants in this condition did not receive an intervention. |
|
|