Clinical trial NCT04843163: Examining the Impact of a Peer-Provided Psychoeducational Program for Parents: NAMI Basics
Official title: Examining the Impact of a Peer-Provided Psychoeducational Program for Parents: NAMI Basics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Disorder, Child
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2021-04-13
Enrollment: 137
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed description: 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. It is 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. Families may be just beginning to recognize their child has a mental health challenge or may have been involved in service systems for many years. The program has been fully translated into Spanish, as well, and can be provided by Spanish-speaking trainers in many communities (known as Bases y Fundamentos de NAMI). NAMI Basics offers an inexpensive, non-stigmatizing strategy to increase families' access to information, training, and support in caring for their child with behavioral health challenges. The program can serve as an adjunct to traditional services or as a stand-alone program.

An initial pilot trial of NAMI Basics demonstrated pre-post increases in knowledge about youth mental illness and advocacy among a sample of 85 caregivers. A second study of 36 caregivers participating in NAMI Basics replicated and extended these results, demonstrating an increase in family empowerment and caregiver self-care, and reductions in inflammatory communication. However, more rigorous testing of the impact of the intervention, similar to that conducted with its "sister" program, needs to be conducted.

In order to more rigorously test the promising NAMI Basics program, we propose a randomized effectiveness trial. 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. The NAMI Basics classes will be studied within five local NAMI affiliates in Texas. As the NAMI Basics program is translated and provided in Spanish, both Spanish and English classes will be run and evaluated as part of this research study.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in Parental Stress
timeFrame: 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)
measure: Change in Parent Self-Competence, Expectancies, Efficacy, Knowledge, Self-Care
timeFrame: 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)
measure: Change in Child Mental Health Symptoms
timeFrame: 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)
measure: Family Problem Solving and Communication
timeFrame: 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)
measure: Change in Mental Health Service Use
timeFrame: 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)
measure: Change in Parent Attitudes Towards Psychological Services
timeFrame: 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:
measure: Program Satisfaction
timeFrame: Wave A: 6-8 weeks after class start, Wave B: 12 weeks after randomization and immediately after NAMI Basics class
Other outcomes:
Locations:
city: Austin
country: United States
facility: The University of Texas at Austin
state: Texas
Study officials:
affiliation: The University of Texas at Austin
name: Sarah Kate Bearman, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Texas at Austin
name: Molly Lopez, PhD
role: PRINCIPAL_INVESTIGATOR
References: