Trial Outcomes & Findings for Padres Efectivos (Parent Activation): Skills Latina Mothers Use to Get Healthcare for Their Children (NCT NCT02329431)

Last Updated: 2017-07-07

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

181 participants

Primary outcome timeframe

1 and 3 months

Results posted on

2017-07-07

Participant Flow

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

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

Participant milestones

Participant milestones
Measure	Activation Curriculum Psycho-social curriculum teaching activation skills activation curriculum: psychosocial activation curriculum	Support Group Parent-directed support group support group: parent directed support group
Overall Study STARTED	92	89
Overall Study Baseline Interview	87	85
Overall Study COMPLETED	72	76
Overall Study NOT COMPLETED	20	13

Reasons for withdrawal

Reasons for withdrawal
Measure	Activation Curriculum Psycho-social curriculum teaching activation skills activation curriculum: psychosocial activation curriculum	Support Group Parent-directed support group support group: parent directed support group
Overall Study Lost to Follow-up	20	13

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Activation Curriculum n=87 Participants Psycho-social curriculum teaching activation skills activation curriculum: psychosocial activation curriculum	Support Group n=85 Participants Parent-directed support group support group: parent directed support group	Total n=172 Participants Total of all reporting groups
Age, Continuous	35.3 years STANDARD_DEVIATION 6.9 • n=5 Participants	36.4 years STANDARD_DEVIATION 6.3 • n=7 Participants	35.8 years STANDARD_DEVIATION 6.6 • n=5 Participants
Sex: Female, Male Female	84 Participants n=5 Participants	84 Participants n=7 Participants	168 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	87 Participants n=5 Participants	85 Participants n=7 Participants	172 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	87 Participants n=5 Participants	85 Participants n=7 Participants	172 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	87 Participants n=5 Participants	85 Participants n=7 Participants	172 Participants n=5 Participants
Medicaid coverage	62 Participants n=5 Participants	62 Participants n=7 Participants	124 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 and 3 months

Population: Completed a baseline interview

Outcome measures

Outcome measures
Measure	Activation Curriculum n=87 Participants Psycho-social curriculum teaching activation skills activation curriculum: psychosocial activation curriculum	Support Group n=85 Participants Parent-directed support group support group: parent directed support group
Patient Activation Measure patient activation measure 1-month	88.08 scores on a scale Standard Deviation 12.13	84.73 scores on a scale Standard Deviation 12.65
Patient Activation Measure patient activation measure 3-months	92.75 scores on a scale Standard Deviation 10.52	91.63 scores on a scale Standard Deviation 11.13

SECONDARY outcome

Timeframe: 1 and 3 months

Population: Completed a baseline interview

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.

Outcome measures

Outcome measures
Measure	Activation Curriculum n=87 Participants Psycho-social curriculum teaching activation skills activation curriculum: psychosocial activation curriculum	Support Group n=85 Participants Parent-directed support group support group: parent directed support group
8-item Patient Health Questionnaire (PHQ-8) patient health questionnaire-8 1-month	4.63 scores on a scale Standard Deviation 5.91	3.49 scores on a scale Standard Deviation 4.34
8-item Patient Health Questionnaire (PHQ-8) patient health questionnaire-8 3-months	3.89 scores on a scale Standard Deviation 4.63	3.47 scores on a scale Standard Deviation 4.43

SECONDARY outcome

Timeframe: 1 and 3 months

Population: Completed a baseline interview

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).

Outcome measures

Outcome measures
Measure	Activation Curriculum n=87 Participants Psycho-social curriculum teaching activation skills activation curriculum: psychosocial activation curriculum	Support Group n=85 Participants Parent-directed support group support group: parent directed support group
Parental Stress Scale parental stress scale 1-month	28.51 scores on a scale Standard Deviation 7.63	29.97 scores on a scale Standard Deviation 6.90
Parental Stress Scale parental stress scale 3-months	26.68 scores on a scale Standard Deviation 6.69	27.25 scores on a scale Standard Deviation 6.61

SECONDARY outcome

Timeframe: 1 month

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

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.

Outcome measures

Outcome measures
Measure	Activation Curriculum n=55 Participants Psycho-social curriculum teaching activation skills activation curriculum: psychosocial activation curriculum	Support Group n=63 Participants Parent-directed support group support group: parent directed support group
Parent Activation, Qualitative parent disagreed with therapist	4 Participants	5 Participants
Parent Activation, Qualitative parent mentioned speaking with child's teacher	16 Participants	16 Participants

SECONDARY outcome

Timeframe: baseline to 4-month follow-up

Population: Target child with any scheduled clinic visits

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.

Outcome measures

Outcome measures
Measure	Activation Curriculum n=87 Participants Psycho-social curriculum teaching activation skills activation curriculum: psychosocial activation curriculum	Support Group n=84 Participants Parent-directed support group support group: parent directed support group
Number of Clinic Visits Child Attended Over 4 Months	4.2 visits Standard Deviation 2.8	4.0 visits Standard Deviation 2.8

SECONDARY outcome

Timeframe: baseline to 4-month follow-up

Population: Target child with any scheduled visits

Outcome measures

Outcome measures
Measure	Activation Curriculum n=87 Participants Psycho-social curriculum teaching activation skills activation curriculum: psychosocial activation curriculum	Support Group n=84 Participants Parent-directed support group support group: parent directed support group
Child Visit No-shows Over 4 Months	0.7 visits Standard Deviation 0.9	0.6 visits Standard Deviation 1.0

Adverse Events

Activation Curriculum

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Support Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kathleen Thomas

UNC Chapel Hill

Phone: 919-966-3387

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place