NCT02329431

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
181

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

December 29, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 31, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
8 months until next milestone

Results Posted

Study results publicly available

July 7, 2017

Completed
Last Updated

July 7, 2017

Status Verified

April 1, 2017

Enrollment Period

2.9 years

First QC Date

December 29, 2014

Results QC Date

October 29, 2016

Last Update Submit

April 12, 2017

Conditions

Keywords

child mental health, mental health services, Latino families

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

EXPERIMENTAL

Psycho-social curriculum teaching activation skills

Behavioral: activation curriculum

support group

ACTIVE COMPARATOR

Parent-directed support group

Behavioral: support group

Interventions

psychosocial activation curriculum

activation curriculum
support groupBEHAVIORAL

parent directed support group

support group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Mental Disorders

Interventions

Self-Help Groups

Intervention Hierarchy (Ancestors)

OrganizationsHealth Care Economics and Organizations

Results Point of Contact

Title
Kathleen Thomas
Organization
UNC Chapel Hill

Study Officials

  • Kathleen C Thomas, PhD

    UNC Chapel Hill

    PRINCIPAL INVESTIGATOR

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

Locations