Padres Efectivos (Parent Activation): Skills Latina Mothers Use to Get Healthcare for Their Children

Mental Disorders Clinical Trial

Official title:

Padres Efectivos (Parent Activation): Skills Latina Mothers Use to Get Healthcare for Their Children

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02329431
• Other study ID #: 13-2106
• Status: Active, not recruiting
• Phase: N/A
• First received: December 29, 2014
• Last updated: October 26, 2016
• Start date: August 2013
• Est. completion date: November 2016

Study information

• Verified date: October 2016
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The goal of this study is to develop an intervention to teach activation skills to Latino parents who bring children for mental health services.

Description:

Background:

Latinos are the largest and fastest growing minority population in the US; by 2050, 2 in 5 children will be Latino. Latino children are disproportionately affected by poverty and other factors associated with increased risk of psychiatric disorder. However, Latino children with mental health needs are half as likely to use services as children in white non-Latino families. Latino families are more likely to report problems getting services, lack of a usual source of care and a medical home, and dissatisfaction with the care they receive. Unmet mental health needs, in turn, are associated with poor outcomes over the lifespan, both economic and social. Assessing the comparative effectiveness of interventions to overcome these disparities is a major national health priority central to PCORI's mission and mandate.

Activation is a promising focus of research to eliminate disparities because it reflects a set of attitudes and skills that people can use to reduce disparities. Our work provides evidence that activation in Latino adults is associated with better quality health care and outcomes; and in African American parents with greater child mental health service use. There is need for further research on parent-focused interventions founded on culturally meaningful concepts to address these needs and disparities.

Objectives:

The long-term goal of this research is to improve the mental health care and outcomes of Latino children with mental health needs. The proposed study will examine the comparative effectiveness of an activation intervention for Latino families raising children with mental health needs by means of three aims:

Aim 1. To identify parent-reported facilitators of Latino child mental health service use amenable to change through parental activation Aim 2. To test the comparative effectiveness of an adapted psycho-educational intervention to teach activation skills adapted for Latino mothers of children with mental health needs compared to a parent support group control Aim

3. To enhance the intervention, based on parent input and lessons learned from the first trial, and test its comparative effectiveness with a parent support group control

Methods:

Qualitative and quantitative data from Latino mothers who have a child with mental health needs (n=294) will be used in a difference-in-difference mixed effects approach to address these aims.

Projected Patient Outcomes:

The proposed study will provide evidence of the comparative effectiveness of an enhanced, culturally sensitive, advocacy skills intervention to build activation among Latino families and improve service use of their children with mental health needs compared to a preliminary adaptation of an existing intervention and to a usual care discussion group. Activation skills are a promising strategy to improve child mental health service use and to bridge cultural differences and disparities with wide-ranging impacts consistent with PCORI's research agenda.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 302
• Est. completion date: November 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• For children:

• seeking services at target clinic

• maximum age 22 years

• For caregivers:

• Latino ethnicity

• bringing child for services to target clinic

• able to attend a weekly class for 4 weeks

• able to give informed consent

Exclusion Criteria:

• For children:

• not living with potential participant caregiver

• For caregiver:

• not living with target child

• evidence of emergency mental health needs

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Mental Disorders
• Psychotic Disorders

Intervention

Behavioral:
• activation curriculum
psychosocial activation curriculum
• support group
parent directed support group

Locations

Country	Name	City	State
United States	UNC Chapel Hill	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	University of North Carolina, Greensboro

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	parent activation	self-report patient activation measure	up to 3 months	No
Secondary	caregiver depression	patient health questionnaire	baseline, 1 and 3 months	No
Secondary	caregiver stress	parental stress scale	baseline, 1 and 3 months	No
Secondary	parent activation, qualitative	qualitative assessment from audio-taped parent-provider conversation	1 month	No
Secondary	Child service use, attendance at visits	proportion of visits attended	1-3 months following intervention	No
Secondary	Child service use, no shows	proportion of scheduled visits skipped without rescheduling	1-3 months following intervention	No