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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02329431
Enrollment
181
Registered
2014-12-31
Start date
2013-08-31
Completion date
2016-11-30
Last updated
2017-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mental Disorders

Keywords

child mental health, mental health services, Latino families

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.

Interventions

BEHAVIORALactivation curriculum

psychosocial activation curriculum

BEHAVIORALsupport group

parent directed support group

Sponsors

University of North Carolina, Greensboro
CollaboratorOTHER
University of North Carolina, Chapel Hill
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Patient Activation Measure1 and 3 monthsThe 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

MeasureTime frameDescription
8-item Patient Health Questionnaire (PHQ-8)1 and 3 monthsParent 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 Scale1 and 3 monthsParent 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, Qualitative1 monthWe 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 Monthsbaseline to 4-month follow-upWe 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 Monthsbaseline to 4-month follow-upWe 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.

Countries

United States

Participant flow

Recruitment details

Recruitment was from a Spanish-language mental health clinic, November 2013 through August, 2015

Pre-assignment details

Evaluation criteria were focal child not living with potential participant and evidence of urgent parent mental health needs

Participants by arm

ArmCount
Activation Curriculum
Psycho-social curriculum teaching activation skills activation curriculum: psychosocial activation curriculum
87
Support Group
Parent-directed support group support group: parent directed support group
85
Total172

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up2013

Baseline characteristics

CharacteristicActivation CurriculumTotalSupport Group
Age, Continuous35.3 years
STANDARD_DEVIATION 6.9
35.8 years
STANDARD_DEVIATION 6.6
36.4 years
STANDARD_DEVIATION 6.3
Ethnicity (NIH/OMB)
Hispanic or Latino
87 Participants172 Participants85 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Medicaid coverage62 Participants124 Participants62 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
87 Participants172 Participants85 Participants
Region of Enrollment
United States
87 Participants172 Participants85 Participants
Sex: Female, Male
Female
84 Participants168 Participants84 Participants
Sex: Female, Male
Male
3 Participants4 Participants1 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 920 / 89
serious
Total, serious adverse events
0 / 920 / 89

Outcome results

Primary

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.

Time frame: 1 and 3 months

Population: Completed a baseline interview

ArmMeasureGroupValue (MEAN)Dispersion
Activation CurriculumPatient Activation Measurepatient activation measure 1-month88.08 scores on a scaleStandard Deviation 12.13
Activation CurriculumPatient Activation Measurepatient activation measure 3-months92.75 scores on a scaleStandard Deviation 10.52
Support GroupPatient Activation Measurepatient activation measure 1-month84.73 scores on a scaleStandard Deviation 12.65
Support GroupPatient Activation Measurepatient activation measure 3-months91.63 scores on a scaleStandard Deviation 11.13
Secondary

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.

Time frame: 1 and 3 months

Population: Completed a baseline interview

ArmMeasureGroupValue (MEAN)Dispersion
Activation Curriculum8-item Patient Health Questionnaire (PHQ-8)patient health questionnaire-8 1-month4.63 scores on a scaleStandard Deviation 5.91
Activation Curriculum8-item Patient Health Questionnaire (PHQ-8)patient health questionnaire-8 3-months3.89 scores on a scaleStandard Deviation 4.63
Support Group8-item Patient Health Questionnaire (PHQ-8)patient health questionnaire-8 1-month3.49 scores on a scaleStandard Deviation 4.34
Support Group8-item Patient Health Questionnaire (PHQ-8)patient health questionnaire-8 3-months3.47 scores on a scaleStandard Deviation 4.43
Secondary

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.

Time frame: baseline to 4-month follow-up

Population: Target child with any scheduled visits

ArmMeasureValue (MEAN)Dispersion
Activation CurriculumChild Visit No-shows Over 4 Months0.7 visitsStandard Deviation 0.9
Support GroupChild Visit No-shows Over 4 Months0.6 visitsStandard Deviation 1
Secondary

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.

Time frame: baseline to 4-month follow-up

Population: Target child with any scheduled clinic visits

ArmMeasureValue (MEAN)Dispersion
Activation CurriculumNumber of Clinic Visits Child Attended Over 4 Months4.2 visitsStandard Deviation 2.8
Support GroupNumber of Clinic Visits Child Attended Over 4 Months4.0 visitsStandard Deviation 2.8
Secondary

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.

Time frame: 1 month

Population: Completed baseline interview and had an audio-recorded visit

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Activation CurriculumParent Activation, Qualitativeparent disagreed with therapist4 Participants
Activation CurriculumParent Activation, Qualitativeparent mentioned speaking with child's teacher16 Participants
Support GroupParent Activation, Qualitativeparent disagreed with therapist5 Participants
Support GroupParent Activation, Qualitativeparent mentioned speaking with child's teacher16 Participants
Secondary

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).

Time frame: 1 and 3 months

Population: Completed a baseline interview

ArmMeasureGroupValue (MEAN)Dispersion
Activation CurriculumParental Stress Scaleparental stress scale 1-month28.51 scores on a scaleStandard Deviation 7.63
Activation CurriculumParental Stress Scaleparental stress scale 3-months26.68 scores on a scaleStandard Deviation 6.69
Support GroupParental Stress Scaleparental stress scale 1-month29.97 scores on a scaleStandard Deviation 6.9
Support GroupParental Stress Scaleparental stress scale 3-months27.25 scores on a scaleStandard Deviation 6.61

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026