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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Health Services Research
Condition Mental Disorders
Interventions Behavioral: activation curriculum
Behavioral: support group
Enrollment 181
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
Arm/Group Title Activation Curriculum Support Group
Hide Arm/Group Description

Psycho-social curriculum teaching activation skills

activation curriculum: psychosocial activation curriculum

Parent-directed support group

support group: parent directed support group

Period Title: Overall Study
Started 92 89
Baseline Interview 87 85
Completed 72 76
Not Completed 20 13
Reason Not Completed
Lost to Follow-up             20             13
Arm/Group Title Activation Curriculum Support Group Total
Hide Arm/Group Description

Psycho-social curriculum teaching activation skills

activation curriculum: psychosocial activation curriculum

Parent-directed support group

support group: parent directed support group

Total of all reporting groups
Overall Number of Baseline Participants 87 85 172
Hide Baseline Analysis Population Description
Completed a baseline interview
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 87 participants 85 participants 172 participants
35.3  (6.9) 36.4  (6.3) 35.8  (6.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 87 participants 85 participants 172 participants
Female
84
  96.6%
84
  98.8%
168
  97.7%
Male
3
   3.4%
1
   1.2%
4
   2.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 87 participants 85 participants 172 participants
Hispanic or Latino
87
 100.0%
85
 100.0%
172
 100.0%
Not Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 87 participants 85 participants 172 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
87
 100.0%
85
 100.0%
172
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 87 participants 85 participants 172 participants
87
 100.0%
85
 100.0%
172
 100.0%
Medicaid coverage   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 87 participants 85 participants 172 participants
62
  71.3%
62
  72.9%
124
  72.1%
[1]
Measure Description: Target child covered by Medicaid
1.Primary Outcome
Title Patient Activation Measure
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Completed a baseline interview
Arm/Group Title Activation Curriculum Support Group
Hide Arm/Group Description:

Psycho-social curriculum teaching activation skills

activation curriculum: psychosocial activation curriculum

Parent-directed support group

support group: parent directed support group

Overall Number of Participants Analyzed 87 85
Mean (Standard Deviation)
Unit of Measure: scores on a scale
patient activation measure 1-month 88.08  (12.13) 84.73  (12.65)
patient activation measure 3-months 92.75  (10.52) 91.63  (11.13)
2.Secondary Outcome
Title 8-item Patient Health Questionnaire (PHQ-8)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Completed a baseline interview
Arm/Group Title Activation Curriculum Support Group
Hide Arm/Group Description:

Psycho-social curriculum teaching activation skills

activation curriculum: psychosocial activation curriculum

Parent-directed support group

support group: parent directed support group

Overall Number of Participants Analyzed 87 85
Mean (Standard Deviation)
Unit of Measure: scores on a scale
patient health questionnaire-8 1-month 4.63  (5.91) 3.49  (4.34)
patient health questionnaire-8 3-months 3.89  (4.63) 3.47  (4.43)
3.Secondary Outcome
Title Parental Stress Scale
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Completed a baseline interview
Arm/Group Title Activation Curriculum Support Group
Hide Arm/Group Description:

Psycho-social curriculum teaching activation skills

activation curriculum: psychosocial activation curriculum

Parent-directed support group

support group: parent directed support group

Overall Number of Participants Analyzed 87 85
Mean (Standard Deviation)
Unit of Measure: scores on a scale
parental stress scale 1-month 28.51  (7.63) 29.97  (6.90)
parental stress scale 3-months 26.68  (6.69) 27.25  (6.61)
4.Secondary Outcome
Title Parent Activation, Qualitative
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Completed baseline interview and had an audio-recorded visit
Arm/Group Title Activation Curriculum Support Group
Hide Arm/Group Description:

Psycho-social curriculum teaching activation skills

activation curriculum: psychosocial activation curriculum

Parent-directed support group

support group: parent directed support group

Overall Number of Participants Analyzed 55 63
Measure Type: Count of Participants
Unit of Measure: Participants
parent disagreed with therapist
4
   7.3%
5
   7.9%
parent mentioned speaking with child's teacher
16
  29.1%
16
  25.4%
5.Secondary Outcome
Title Number of Clinic Visits Child Attended Over 4 Months
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Target child with any scheduled clinic visits
Arm/Group Title Activation Curriculum Support Group
Hide Arm/Group Description:

Psycho-social curriculum teaching activation skills

activation curriculum: psychosocial activation curriculum

Parent-directed support group

support group: parent directed support group

Overall Number of Participants Analyzed 87 84
Mean (Standard Deviation)
Unit of Measure: visits
4.2  (2.8) 4.0  (2.8)
6.Secondary Outcome
Title Child Visit No-shows Over 4 Months
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Target child with any scheduled visits
Arm/Group Title Activation Curriculum Support Group
Hide Arm/Group Description:

Psycho-social curriculum teaching activation skills

activation curriculum: psychosocial activation curriculum

Parent-directed support group

support group: parent directed support group

Overall Number of Participants Analyzed 87 84
Mean (Standard Deviation)
Unit of Measure: visits
0.7  (0.9) 0.6  (1.0)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Activation Curriculum Support Group
Hide Arm/Group Description

Psycho-social curriculum teaching activation skills

activation curriculum: psychosocial activation curriculum

Parent-directed support group

support group: parent directed support group

All-Cause Mortality
Activation Curriculum Support Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Activation Curriculum Support Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/92 (0.00%)   0/89 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Activation Curriculum Support Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/92 (0.00%)   0/89 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Kathleen Thomas
Organization: UNC Chapel Hill
Phone: 919-966-3387
EMail: kathleen_thomas@unc.edu
Layout table for additonal information
Responsible Party: Kathleen Thomas, PhD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02329431    
Other Study ID Numbers: 13-2106
First Submitted: December 29, 2014
First Posted: December 31, 2014
Results First Submitted: October 29, 2016
Results First Posted: July 7, 2017
Last Update Posted: July 7, 2017