ADHD Treatment for Latino Families

Study Overview
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Brief Summary
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The current pilot study aims to close the existing gap in our knowledge about effective psychosocial treatments for Latino families by providing preliminary data regarding the acceptability and efficacy of a culturally-modified ADHD treatment and possible moderators that will support a future R01. Specifically, the current pilot study is the first step in a larger program of research aimed at definitively determining if culturally-modified ADHD treatment outperforms standard treatment when examining engagement and acceptability outcomes, as well as symptomatology and parental functioning, and if so, which treatment modifications are necessary and for whom. The following study aims will be examined. Aim 1 is to explore if the culturally-modified treatment results in better engagement and acceptability outcomes (i.e., parental attendance, retention, engagement, and satisfaction) than standard treatment and to determine the strength of these effects. Aim 2 is to explore if the culturally-modified treatment results in improvements in ADHD symptomatology, as well as parental functioning (i.e., parenting stress and efficacy), to explore if the modified treatment results in similar or greater improvements than standard treatment, and to determine the strength of these effects. Aim 3 is to explore possible moderators (i.e., socioeconomic status (SES) and behavioral and cognitive acculturation) that may explain the relationship between treatment type (i.e., standard versus culturally-modified) and outcomes and to determine the strength of these interactions.

Official Title
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Standard Versus Culturally-Modified ADHD Treatment

Conditions
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ADHD

Intervention / Treatment
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* Behavioral: Parent training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children must Self-identify as Latino and be between the ages of 5 and 13 years at the time of the initial assessment Receive a primary diagnosis of ADHD If medicated for ADHD, be on a stable dose of medication for at least two weeks prior to the assessment Participating parents must Self-identify as Latino Be fluent in Spanish Be able and willing to provide informed consent and comply with the study procedures, including being assigned either to standard or culturally-modified treatment Have no immediate plans to pursue other treatment for their child's ADHD or to change their child's medication (if already medicated) over the next eight weeks Exclusion Criteria: Children must not meet DSM-5 diagnostic criteria for Intellectual Disability, Autism Spectrum Disorder, or a psychotic disorder

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard ADHD parent training<br>8 sessions of evidence-based parent training plus school intervention | Behavioral: Parent training<br> <br> |
| Experimental: Culturally-modified ADHD parent training<br>8 sessions of culturally-modified parent training plus school intervention | Behavioral: Parent training<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Engagement in Treatment - Treatment Completion (Number of Families Who Completed Treatment) | Number of families who completed treatment (recorded by clinician) | 8 weeks | 
| Engagement in Treatment - Sessions Attended | Number of sessions attended by each family (recorded by clinician) | 8 weeks | 
| Engagement in Treatment - Homework Completion (% of Completed Homework) | (recorded by clinician - homework was assigned every week and was expected to be returned at the next week's session) | 8 weeks | 
| Acceptability of Treatment (Summary Score of Therapy Attitude Inventory) | Parental report of satisfaction with treatment (summary score of Therapy Attitude Inventory) Range=10-50; higher scores represent greater satisfaction (a better outcome) | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in ADHD Symptoms (Inattention Subscale of Disruptive Behavior Disorders Rating Scale) | Pre-treatment to post-treatment change on inattention subscale of Disruptive Behavior Disorders Rating Scale (completed by parent) Range=0-3; the larger the number, the greater the symptoms Difference in mean pre and post scores for each group, so SD was not calculated. | Baseline to 8 weeks | 
| Change in Parental Functioning (Maternal Parenting Stress) | Pre-treatment to post-treatment change on summary score of Parenting Stress Index-Short Form (completed by mothers) Range=0-144; the larger the number, the greater stress Difference in mean pre and post scores for each group, so SD was not calculated. | 8 weeks | 
| Effects of Socioeconomic Status and Parental Acculturation on Treatment Outcomes (Parental Report) | Socioeconomic status computed based on parental report of education and occupation (assessed on demographic form). Acculturation based on parental report on the Acculturation Rating Scale for Mexican Americans-II and the Mexican American Cultural Values for Adolescents and Adults. | 8 weeks |