Examining the Impact of a Peer-Provided Psychoeducational Program for Parents: NAMI Basics

Mental Disorder, Child Clinical Trial

Official title:

Examining the Impact of a Peer-Provided Psychoeducational Program for Parents: NAMI Basics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04843163
• Other study ID #: LEAPLabUTNAMIBasics
• Status: Completed
• Phase: N/A
• Start date: December 6, 2017
• Est. completion date: February 10, 2020

Study information

• Verified date: April 2021
• Source: University of Texas at Austin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: February 10, 2020
• Est. primary completion date: February 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Mental Disorder, Child
• Mental Disorders
• Neurodevelopmental Disorders

Intervention

Behavioral:
• NAMI Basics
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.

Locations

Country	Name	City	State
United States	The University of Texas at Austin	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas at Austin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	Program Satisfaction	NAMI Basics Program Evaluation. This measure assesses satisfaction with participation in the NAMI Basics course, solicits information from caregivers about how the program could be improved, and collects basic demographic information. It consists of 24 items total. The questionnaire includes 14 statements about the program and caregiver confidence in managing various situations. Caregivers are asked to rate these statements as on Likert-type scale from strongly agree to strongly disagree. The measure also includes 5 open-ended questions where caregivers are asked for their impression of the program, and any suggestion for improvement. Finally, the measure includes 5 questions which collect basic demographic information such as age, gender, race/ethnicity and how they were first referred to the NAMI Basics course.	Wave A: 6-8 weeks after class start, Wave B: 12 weeks after randomization and immediately after NAMI Basics class