Padres Efectivos (Parent Activation): Skills Latina Mothers Use to Get Healthcare for Their Children
1 other identifier
interventional
181
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 29, 2014
CompletedFirst Posted
Study publicly available on registry
December 31, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2016
CompletedResults Posted
Study results publicly available
July 7, 2017
CompletedJuly 7, 2017
April 1, 2017
2.9 years
December 29, 2014
October 29, 2016
April 12, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
1 and 3 months
Secondary Outcomes (5)
8-item Patient Health Questionnaire (PHQ-8)
1 and 3 months
Parental Stress Scale
1 and 3 months
Parent Activation, Qualitative
1 month
Number of Clinic Visits Child Attended Over 4 Months
baseline to 4-month follow-up
Child Visit No-shows Over 4 Months
baseline to 4-month follow-up
Study Arms (2)
activation curriculum
EXPERIMENTALPsycho-social curriculum teaching activation skills
support group
ACTIVE COMPARATORParent-directed support group
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- For children:
- not living with potential participant caregiver
- For caregiver:
- not living with target child
- evidence of emergency mental health needs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UNC Chapel Hill
Chapel Hill, North Carolina, 27514, United States
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Kathleen Thomas
- Organization
- UNC Chapel Hill
Study Officials
- PRINCIPAL INVESTIGATOR
Kathleen C Thomas, PhD
UNC Chapel Hill
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Fellow and Adjunt Associate Professor
Study Record Dates
First Submitted
December 29, 2014
First Posted
December 31, 2014
Study Start
August 1, 2013
Primary Completion
July 1, 2016
Study Completion
November 1, 2016
Last Updated
July 7, 2017
Results First Posted
July 7, 2017
Record last verified: 2017-04