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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE December 29, 2014
First Posted Date  ICMJE December 31, 2014
Results First Submitted Date  ICMJE October 29, 2016
Results First Posted Date  ICMJE July 7, 2017
Last Update Posted Date July 7, 2017
Study Start Date  ICMJE August 2013
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 12, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 30, 2014)
  • parent activation [ Time Frame: up to 3 months ]
    self-report patient activation measure
  • parent activation [ Time Frame: 1 month ]
    qualitative assessment from audio-taped parent-provider conversation
  • child service use [ Time Frame: 1 to 3 months ]
    proportion of scheduled visits attended
  • child service use [ Time Frame: 1 to 3 months ]
    proportion of scheduled visits skipped without rescheduling
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 12, 2017)
  • 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.
  • 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).
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 30, 2014)
  • caregiver depression [ Time Frame: baseline, 1 and 3 months ]
    patient health questionnaire
  • caregiver stress [ Time Frame: baseline, 1 and 3 months ]
    parental stress scale
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Padres Efectivos (Parent Activation): Skills Latina Mothers Use to Get Healthcare for Their Children
Official Title  ICMJE Padres Efectivos (Parent Activation): Skills Latina Mothers Use to Get Healthcare for Their Children
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Health Services Research
Condition  ICMJE Mental Disorders
Intervention  ICMJE
  • Behavioral: activation curriculum
    psychosocial activation curriculum
  • Behavioral: support group
    parent directed support group
Study Arms  ICMJE
  • Experimental: activation curriculum
    Psycho-social curriculum teaching activation skills
    Intervention: Behavioral: activation curriculum
  • Active Comparator: support group
    Parent-directed support group
    Intervention: Behavioral: support group
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 12, 2017)
181
Original Estimated Enrollment  ICMJE
 (submitted: December 30, 2014)
270
Actual Study Completion Date  ICMJE November 2016
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02329431
Other Study ID Numbers  ICMJE 13-2106
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Kathleen Thomas, PhD, University of North Carolina, Chapel Hill
Study Sponsor  ICMJE University of North Carolina, Chapel Hill
Collaborators  ICMJE University of North Carolina, Greensboro
Investigators  ICMJE
Principal Investigator: Kathleen C Thomas, PhD UNC Chapel Hill
PRS Account University of North Carolina, Chapel Hill
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP