NCT04843163

Brief Summary

This study will evaluate a peer service program for caregivers of youth struggling with mental illness using a program developed by the National Alliance on Mental Illness (NAMI) called NAMI Basics. This peer service program for caregivers was adapted from their successful and empirically supported model for caregivers of adult children with mental illness (Family-to-Family). The child-focused intervention, NAMI Basics, is a six-class curriculum focused on increasing caregiver knowledge about mental illness, empowering parents to advocate for their children across service systems, and introducing skills that assist in family problem-solving and communication. The current study is a randomized effectiveness trial of NAMI Basics. Caregivers who are parenting youth with a mental illness (N = 175) referred to the NAMI Basics program through natural referral routes will be given the option to participate in the study, and if interested, randomly assigned to either an immediate NAMI Basics classes (Wave A) or an 8-week delay condition (Wave B), followed by initiation of the NAMI Basics class.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
137

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2017

Typical duration 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 6, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2020

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 5, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 13, 2021

Completed
Last Updated

April 13, 2021

Status Verified

April 1, 2021

Enrollment Period

2.2 years

First QC Date

April 5, 2021

Last Update Submit

April 8, 2021

Conditions

Outcome Measures

Primary Outcomes (6)

  • Change in Parental Stress

    Parental Stress Scale (PSS). The PSS (Berry \& Jones, 1995) is a self-report measure that assesses the level of stress experienced by caregivers and includes both positive and negative aspects of parenting. The measure is designed to assess changes in parental stress and changes in parenting capacity for parents who have access to services and targeted support. It consists of 18 items measured on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). The items are statements about typical interactions with the child, both positive and negative, and caregivers must indicate the extent to which the agree or disagree with the statements.

    Wave A: Baseline (Pre Intervention), 6 weeks - 8 weeks from class start (post intervention) ,and 6 month after class completion, Wave B: Baseline (Pre Intervention), 6 weeks (post waitlist), 12 weeks (directly after class completion)

  • Change in Parent Self-Competence, Expectancies, Efficacy, Knowledge, Self-Care

    Parent-Self-Competence Expectancies Efficacy Knowledge Self-Care (P-SEEKS). The PSEEKS (Olin, Kutash, \& Hoagwood, N.d.) is a self-report measure that assesses parent self-efficacy and activation for parents of children with mental health needs. It is designed to capture changes in the area of self-efficacy for parents receiving targeted services or support. It includes measures across 6 domains: positive expectations about activation, self-competence, confidence and affirmation of parent role, self-care skills related to personal well-being, knowledge of formal mental health systems, knowledge of information networks and supports, and mental health services self-efficacy and the confidence to act. It consists of 31 items measured on 4-point Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree).

    Wave A: Baseline (Pre Intervention), 6 weeks - 8 weeks from class start (post intervention) ,and 6 month after class completion, Wave B: Baseline (Pre Intervention), 6 weeks (post waitlist), 12 weeks (directly after class completion)

  • Change in Child Mental Health Symptoms

    Youth Outcome Questionnaire (Burlingame, Wells, Hoag, et al., 2012; Y-OQ 2.01). The Y-OQ is a measure completed by caregivers to assess child treatment progress while receiving intervention. It is designed to be used with caregivers of children ages 4-17 and to capture total amount of distress experienced by the child. It consists of 64 items and caregivers must rate how frequently the described child behaviors occur. Rating options are: never or almost never, rarely, sometimes, sometimes, or always or almost always. The Y-OQ is published by OQ Measures and has been widely used in research studies.

    Wave A: Baseline (Pre Intervention), 6 weeks - 8 weeks from class start (post intervention) ,and 6 month after class completion, Wave B: Baseline (Pre Intervention), 6 weeks (post waitlist) , 12 weeks (directly after class completion)

  • Family Problem Solving and Communication

    Family Problem Solving and Communication Scale. The Family Problem Solving and Communication Scale (McCubbin, McCubbin \& Thompson, 1998) is a self-report measure used to assess family problem solving and communication style. It consists of 10 items, and caregivers must rate statements about their family's problem solving and communication style as False, Mostly False, Mostly True, or True.

    Wave A: Baseline (Pre Intervention), 6 weeks - 8 weeks from class start (post intervention) ,and 6 month after class completion, Wave B: Baseline (Pre Intervention), 6 weeks (post waitlist) , 12 weeks (directly after class completion)

  • Change in Mental Health Service Use

    The Short Service Assessment for Children and Adolescents- Brief (ShortSACA). The ShortSACA is a measure completed by an interviewer and caregivers to assess a child's use of mental health and social services. This includes the duration, type, frequency, and costs of services used, and includes both school-based and court-services. This tool has been widely used and studied (see Horowitz et al., 2001; Stiffman et al. 2000; Hoagwood et al., 2000). The ShortSACA is a shortened version of the full-length SACA and contains 30 items reflecting use of services over a period of time. This tool has been modified for this study to allow caregivers to complete the measure independently. The measure used for this study contains 28 items.

    Wave A: Baseline (Pre Intervention), 6 weeks - 8 weeks from class start (post intervention) ,and 6 month after class completion, Wave B: Baseline (Pre Intervention), 6 weeks (post waitlist), 12 weeks (directly after class completion)

  • Change in Parent Attitudes Towards Psychological Services

    Parent Attitudes Towards Psychological Services Inventory (PATPSI). The PATPSI (Turner, 2012) is a self-report measure that assesses caregiver attitudes towards outpatient mental health services. It measures help-seeking attitudes, intentions and mental health stigma. This measure consists of 26 items measured on a 5-point Likert scale ranging from 0 (strongly disagree) to 5 (strongly agree). (pre-intervention and post-intervention)

    Wave A: Baseline (Pre Intervention), 6 weeks - 8 weeks from class start (post intervention) ,and 6 month after class completion, Wave B: Baseline (Pre Intervention), 6 weeks (post waitlist) , 12 weeks (directly after class completion)

Secondary Outcomes (1)

  • Program Satisfaction

    Wave A: 6-8 weeks after class start, Wave B: 12 weeks after randomization and immediately after NAMI Basics class

Study Arms (2)

Wave A (Immediate NAMI Basics)

EXPERIMENTAL

Once a participant has completed the questionnaires, that participant will be randomly assigned to either an immediate NAMI Basics class (Wave A), or an 8-week delay (Wave B) condition. Those in the immediate condition will be assigned to take the next available NAMI Basics class. Participants in both groups will be assessed at three time points. Participants in the immediate Basics group (Wave A) condition will be assessed pre-class, post-class, and 6 months after class has ended.

Behavioral: NAMI Basics

Wave B (Waitlist Control)

NO INTERVENTION

Participants in the 8-week delay condition will be able to participate in a NAMI Basics class immediately following the 8-week time frame. Participants in the 8-week delay group (Wave B) will be assessed before the 8-week delay, after the 8-week delay (prior to their Basics course), and after the Basics course.

Interventions

NAMI BasicsBEHAVIORAL

NAMI Basics is a peer service program for caregivers of children with mental health needs. It was created by the National Alliance on Mental Illness (NAMI) and was adapted from their empirically supported model for caregivers of adult children with mental illness (Family-to-Family). The child-focused intervention, NAMI Basics, is a six-class curriculum focused on increasing caregiver knowledge about mental illness, empowering parents to advocate for their children across service systems, and introducing skills that assist in family problem-solving and communication (Brister et al., 2012). The program is currently available widely throughout the U.S. through certified trainers who volunteer with local NAMI affiliates and is provided free of charge to caregivers in a non-stigmatizing community setting (e.g., local school, church, community center). It is open to all caregivers, regardless of mental health diagnosis or time within a treatment system.

Wave A (Immediate NAMI Basics)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Any primary caregivers of youth (aged 2 to 18) with emotional or behavioral health problems referred to the NAMI Basics program via naturally occurring referral systems and who have signed informed consent for participation.
  • Participants must be fluent in English or Spanish.

You may not qualify if:

  • Only one caregiver per identified child (It may occur that two caregivers of the same child will enroll in the class and be interested in participating in the study. If two caregivers of the same child are enrolled in the class and interested in the research study, only one will complete study questionnaires. This will be determined by the caregivers themselves, and they will elect one reporter to complete study questionnaires.)
  • Those who have attended 2 or more class sessions of NAMI Basics previously, at any point.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas at Austin

Austin, Texas, 78721, United States

Location

MeSH Terms

Conditions

Neurodevelopmental Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Sarah Kate Bearman, PhD

    The University of Texas at Austin

    PRINCIPAL INVESTIGATOR
  • Molly Lopez, PhD

    The University of Texas at Austin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Individuals are assigned to immediate NAMI Basics or waitlist control. Those in the waitlist control may take the NAMI Basics class after the 8 week waiting period.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study Principal Investigator

Study Record Dates

First Submitted

April 5, 2021

First Posted

April 13, 2021

Study Start

December 6, 2017

Primary Completion

February 10, 2020

Study Completion

February 10, 2020

Last Updated

April 13, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations