Padres Efectivos (Parent Activation): Skills Latina Mothers Use to Get Healthcare for Their Children
Primary Purpose
Mental Disorders
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
activation curriculum
support group
Sponsored by
About this trial
This is an interventional health services research trial for Mental Disorders focused on measuring child mental health, mental health services, Latino families
Eligibility Criteria
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
Sites / Locations
- UNC Chapel Hill
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
activation curriculum
support group
Arm Description
Psycho-social curriculum teaching activation skills
Parent-directed support group
Outcomes
Primary Outcome Measures
Patient Activation Measure
The Patient Activation Measure (PAM) captured parent activation on behalf of their child. The PAM is an adult self-report 13-item scale with 4-level Likert responses and scores ranging from 0 to 100. Higher scores indicate higher activation. It is valid with excellent reliability. The PAM has been translated into Spanish and has been used successfully in Latina/o patient and general populations (mean=40). The PAM has also been used to measure activation of parents on behalf of their children (mean=70). A change of 4 points in the PAM is associated with improved health behaviors in the general population.
Secondary Outcome Measures
8-item Patient Health Questionnaire (PHQ-8)
Parent depression was measured with the 8-item Patient Health Questionnaire (PHQ-8). The PHQ-8 is scored on a scale from 0 to 27; a higher score reflects greater severity of depression. It has excellent validity and reliability. The parent PHQ-9 has been translated into Spanish and used successfully in Latina/o populations. A change of 5 points in the PHQ-8 is associated with a shift in level of depression.
Parental Stress Scale
Parent stress was measured with the 17-item Parental Stress Scale. The Parental Stress Scale is scored on a scale from 0 to 75, where higher scores reflect greater stress. It has been translated into Spanish, and has been shown to have excellent validity and reliability (for women, mean=22).
Parent Activation, Qualitative
We collected qualitative data on parent-provider communication after completion of the 4-week MePrEPA (metas, preguntar, escuchar, preguntar para aclarar/goals, questioning, listening, questioning to clarify) and parent support groups, in an effort to capture observed activation. We coded when the parent disagreed with therapist and when the parent mentioned speaking with child's teacher.
Number of Clinic Visits Child Attended Over 4 Months
We collected child attendance at clinic visits during a 4-month window of time, during the 3-month period parents were participating in the study and one additional month following. Child clinic visit attendance was measured by number of visits attended.
Child Visit No-shows Over 4 Months
We collected child attendance at clinic visits during a 4-month window of time, during the 3-month period parents were participating in the study and one additional month following. Child clinic visit no-shows were measured by number of visits missed.
Full Information
NCT ID
NCT02329431
First Posted
December 29, 2014
Last Updated
April 12, 2017
Sponsor
University of North Carolina, Chapel Hill
Collaborators
University of North Carolina, Greensboro
1. Study Identification
Unique Protocol Identification Number
NCT02329431
Brief Title
Padres Efectivos (Parent Activation): Skills Latina Mothers Use to Get Healthcare for Their Children
Official Title
Padres Efectivos (Parent Activation): Skills Latina Mothers Use to Get Healthcare for Their Children
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
November 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
University of North Carolina, Greensboro
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Disorders
Keywords
child mental health, mental health services, Latino families
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
181 (Actual)
8. Arms, Groups, and Interventions
Arm Title
activation curriculum
Arm Type
Experimental
Arm Description
Psycho-social curriculum teaching activation skills
Arm Title
support group
Arm Type
Active Comparator
Arm Description
Parent-directed support group
Intervention Type
Behavioral
Intervention Name(s)
activation curriculum
Intervention Description
psychosocial activation curriculum
Intervention Type
Behavioral
Intervention Name(s)
support group
Intervention Description
parent directed support group
Primary Outcome Measure Information:
Title
Patient Activation Measure
Description
The Patient Activation Measure (PAM) captured parent activation on behalf of their child. The PAM is an adult self-report 13-item scale with 4-level Likert responses and scores ranging from 0 to 100. Higher scores indicate higher activation. It is valid with excellent reliability. The PAM has been translated into Spanish and has been used successfully in Latina/o patient and general populations (mean=40). The PAM has also been used to measure activation of parents on behalf of their children (mean=70). A change of 4 points in the PAM is associated with improved health behaviors in the general population.
Time Frame
1 and 3 months
Secondary Outcome Measure Information:
Title
8-item Patient Health Questionnaire (PHQ-8)
Description
Parent depression was measured with the 8-item Patient Health Questionnaire (PHQ-8). The PHQ-8 is scored on a scale from 0 to 27; a higher score reflects greater severity of depression. It has excellent validity and reliability. The parent PHQ-9 has been translated into Spanish and used successfully in Latina/o populations. A change of 5 points in the PHQ-8 is associated with a shift in level of depression.
Time Frame
1 and 3 months
Title
Parental Stress Scale
Description
Parent stress was measured with the 17-item Parental Stress Scale. The Parental Stress Scale is scored on a scale from 0 to 75, where higher scores reflect greater stress. It has been translated into Spanish, and has been shown to have excellent validity and reliability (for women, mean=22).
Time Frame
1 and 3 months
Title
Parent Activation, Qualitative
Description
We collected qualitative data on parent-provider communication after completion of the 4-week MePrEPA (metas, preguntar, escuchar, preguntar para aclarar/goals, questioning, listening, questioning to clarify) and parent support groups, in an effort to capture observed activation. We coded when the parent disagreed with therapist and when the parent mentioned speaking with child's teacher.
Time Frame
1 month
Title
Number of Clinic Visits Child Attended Over 4 Months
Description
We collected child attendance at clinic visits during a 4-month window of time, during the 3-month period parents were participating in the study and one additional month following. Child clinic visit attendance was measured by number of visits attended.
Time Frame
baseline to 4-month follow-up
Title
Child Visit No-shows Over 4 Months
Description
We collected child attendance at clinic visits during a 4-month window of time, during the 3-month period parents were participating in the study and one additional month following. Child clinic visit no-shows were measured by number of visits missed.
Time Frame
baseline to 4-month follow-up
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen C Thomas, PhD
Organizational Affiliation
UNC Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
UNC Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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