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

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ClinicalTrials.gov Identifier: NCT02329431
Recruitment Status : Completed
First Posted : December 31, 2014
Results First Posted : July 7, 2017
Last Update Posted : July 7, 2017
Sponsor:
Collaborator:
University of North Carolina, Greensboro
Information provided by (Responsible Party):
Kathleen Thomas, PhD, University of North Carolina, Chapel Hill

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.

Condition or disease Intervention/treatment Phase
Mental Disorders Behavioral: activation curriculum Behavioral: support group Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 181 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Health Services Research
Official Title: Padres Efectivos (Parent Activation): Skills Latina Mothers Use to Get Healthcare for Their Children
Study Start Date : August 2013
Actual Primary Completion Date : July 2016
Actual Study Completion Date : November 2016

Arm Intervention/treatment
Experimental: activation curriculum
Psycho-social curriculum teaching activation skills
Behavioral: activation curriculum
psychosocial activation curriculum

Active Comparator: support group
Parent-directed support group
Behavioral: support group
parent directed support group




Primary Outcome Measures :
  1. Patient Activation Measure [ Time Frame: 1 and 3 months ]
    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 :
  1. 8-item Patient Health Questionnaire (PHQ-8) [ Time Frame: 1 and 3 months ]
    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.

  2. Parental Stress Scale [ Time Frame: 1 and 3 months ]
    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).

  3. Parent Activation, Qualitative [ Time Frame: 1 month ]
    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.

  4. Number of Clinic Visits Child Attended Over 4 Months [ Time Frame: baseline to 4-month follow-up ]
    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.

  5. Child Visit No-shows Over 4 Months [ Time Frame: baseline to 4-month follow-up ]
    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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02329431


Locations
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United States, North Carolina
UNC Chapel Hill
Chapel Hill, North Carolina, United States, 27514
Sponsors and Collaborators
University of North Carolina, Chapel Hill
University of North Carolina, Greensboro
Investigators
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Principal Investigator: Kathleen C Thomas, PhD UNC Chapel Hill
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Responsible Party: Kathleen Thomas, PhD, Fellow and Adjunt Associate Professor, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02329431    
Other Study ID Numbers: 13-2106
First Posted: December 31, 2014    Key Record Dates
Results First Posted: July 7, 2017
Last Update Posted: July 7, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Kathleen Thomas, PhD, University of North Carolina, Chapel Hill:
child mental health, mental health services, Latino families
Additional relevant MeSH terms:
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Mental Disorders