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Mental Disorder, ChildNCT04843163

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

A study testing NAMI Basics in people with Mental Disorder, Child, run by University of Texas at Austin at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Mental Disorder, Child
What is being tested?
NAMI Basics
Could I receive a placebo?
No, everyone receives an active treatment
How many people
137 participants
Where
1 siteUnited States
Study dates
6 Dec 2017to 10 Feb 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • The University of Texas at Austin

    Austin, Texas, 78721

Other trials in United States

About this study

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.

Read the 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.

Being tested
NAMI Basics
Medical subject headings
Neurodevelopmental Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NAMI BasicsBehavioural

    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.

Study groups in NCT04843163
Study groupRoleWhat they receive
Wave A (Immediate NAMI Basics)ExperimentalOnce 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.
Receives: Behavioral: NAMI Basics
Wave B (Waitlist Control)No interventionParticipants 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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)

  2. 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).

    Measured: 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)

  3. 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.

    Measured: 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)

  4. 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.

    Measured: 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)

  5. 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.

    Measured: 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)

  6. 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)

    Measured: 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)
  1. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2021
  2. Study start6 Dec 2017
  3. Primary completion10 Feb 2020
  4. Study completion10 Feb 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
None (open label)
Enrolment
137 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04843163
Sponsor's protocol ID
LEAPLabUTNAMIBasics
Status last verified
Apr 2021
First submitted
5 Apr 2021
Last updated
13 Apr 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing NAMI Basics in people with Mental Disorder, Child, run by University of Texas at Austin at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Parental Stress (time frame: 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)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2021.

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