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

• 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: University of North Carolina, Chapel Hill
• 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: December 29, 2014
• First Posted Date: December 31, 2014
• Results First Submitted Date: October 29, 2016
• Results First Posted Date: July 7, 2017
• Last Update Posted Date: July 7, 2017
• Study Start Date: August 2013
• Actual Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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

Current Secondary Outcome Measures (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 (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: 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
• 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Health Services Research
• Condition: Mental Disorders

Intervention

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

Study Arms

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 12, 2017): 181
• Original Estimated Enrollment (submitted: December 30, 2014): 270
• Actual Study Completion Date: November 2016
• Actual Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02329431
• Other Study ID Numbers: 13-2106
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Responsible Party: Kathleen Thomas, PhD, University of North Carolina, Chapel Hill
• Study Sponsor: University of North Carolina, Chapel Hill
• Collaborators: University of North Carolina, Greensboro

Investigators

• Principal Investigator: Kathleen C Thomas, PhD; UNC Chapel Hill

• PRS Account: University of North Carolina, Chapel Hill
• Verification Date: April 2017