Mental Health in Primary Care

Browse trials for

• Depression 8,577
• Anxiety Disorders 7,201
• Suicide 607

Keywords

• effectiveness-implementation type 1 hybrid trial
• Latinx mental health in primary care
• Latinx adolescent
• eHealth intervention
• Familias Unidas
• intervention sustainment
• parent-centered
• family functioning
• sexual risk behavior

Depression

8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.

This study's planned enrollment of 468 is above the median of 81 across 7,063 interventional studies indexed under Depression.

Lead sponsor

University of Miami is the lead sponsor of 840 studies on the registry; 164 are open to participants now.

Of its 115 completed or terminated interventional studies of FDA-regulated products, 97 (84%) have results posted.

Study arms

• Experimental
  eHealth Familias Unidas

  Participants in this group will receive eHealth Familias Unidas-Mental Health. The intervention consists of nine video parent group sessions, one video adolescent session, and four family sessions (parents participate in a total of 13 sessions, adolescents participate in a total of five sessions) that will be delivered by a facilitator to the parent-child dyad via web-conferencing software across 13 weeks.

  Behavioral: eHealth Familias Unidas Mental Health

• No intervention
  Prevention as Usual Control

  In this condition, participants will not receive an intervention, only the standard of care services which may include information and referral.

Interventions

• BehavioraleHealth Familias Unidas Mental Health

  eHealth Familias Unidas is a program designed to target mental health and suicide ideation and behavior. It focuses on promoting mental health by strengthening family and interpersonal protective factors. The program is provided online over a total of 13 sessions: 9 video parent group sessions, each lasting 20-40 minutes in Spanish and 4 web family sessions lasting 45 minutes in either Spanish or English, depending on participant language preference. The video parent group sessions consist of: 1) culturally syntonic telenovela/soap opera series, 2) videotaped parent group discussions, 3) interactive exercises. Web family sessions will be conducted by a trained pediatric staff member.

Primary outcomes

1. Depression symptoms

   Change in depression symptom severity will be measured using the Kiddie Computerized Adaptive Test (K-CAT®). K-CAT® measures severity on a scale of 0 to 100 with higher scores indicating greater depression symptom severity.

   Time frame: Baseline to 3 months, baseline to 6 months, baseline to 18 months

2. Anxiety symptoms

   Change in anxiety symptom severity will be measured using the Kiddie Computerized Adaptive Test (K-CAT®). K-CAT® measures severity on a scale of 0 to 100 with higher scores indicating greater anxiety symptom severity.

   Time frame: Baseline to 3 months, baseline to 6 months, baseline to 18 months

3. Suicidality

   Change in suicidality severity will be measured using the Kiddie Computerized Adaptive Test (K-CAT®). K-CAT® measures severity on a scale of 0 to 100 with higher scores indicating greater suicidality symptom severity.

   Time frame: Baseline to 3 months, baseline to 6 months, baseline to 18 months

4. Change in drug use

   Change in drug use will be reported as the number of days drug use was reported over the last 90 days.

   Time frame: Baseline to 3 months, baseline to 6 months, baseline to 18 months

5. Center for Epidemiologic Studies Depression Scale (CESD)

   Change in depression symptoms will be assessed with the CESD. Scores range from 0 to 60 with higher scores indicating the presence of more symptoms.

   Time frame: Baseline to 3 months, baseline to 6 months, baseline to 18 months

Secondary outcomes

1. Change in Family Functioning as assessed by the Parenting Practices Questionnaire

   Change in family functioning will be reported using nine items from the Parenting Practices Questionnaire . Response range varies based on questions, but most response items range from 0 to 4 with higher values indicating better parenting. Scores range from 0 to 36.

   Time frame: Baseline to 3 months, baseline to 6 months, baseline to 18 months

2. 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.

   Time frame: Baseline to 3 months, baseline to 6 months, baseline to 18 months

3. 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.

   Time frame: Baseline to 3 months, baseline to 6 months, baseline to 18 months

4. Change in unprotected sexual behavior

   Change in unprotected sexual behavior will be reported as number of days of sex without a condom as reported over the last 90 days.

   Time frame: Baseline to 3 months, baseline to 6 months, baseline to 18 months

Publications

• Estrada Y, Lozano A, Boga D, Tapia MI, Perrino T, Velazquez MR, Forster L, Torres N, Morales CV, Gwynn L, Beardslee WR, Brown CH, Prado G. eHealth Familias Unidas Mental Health: Protocol for an effectiveness-implementation hybrid Type 1 trial to scale a mental health preventive intervention for Hispanic youth in primary care settings. PLoS One. 2023 Apr 18;18(4):e0283987. doi: 10.1371/journal.pone.0283987. eCollection 2023. PubMed 37071612 ↗

Individual participant data

Plan to share: No