ADHD Treatment for Latino Families

NCT ID: NCT02317692

Last Updated: 2017-10-23

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

147 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2016-12-31

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.

1. 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.
2. 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.
3. 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.

Detailed Description

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Conditions

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ADHD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Standard ADHD parent training

8 sessions of evidence-based parent training plus school intervention

Group Type ACTIVE_COMPARATOR

Parent training

Intervention Type BEHAVIORAL

Culturally-modified ADHD parent training

8 sessions of culturally-modified parent training plus school intervention

Group Type EXPERIMENTAL

Parent training

Intervention Type BEHAVIORAL

Interventions

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Parent training

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Children must

1. Self-identify as Latino and be between the ages of 5 and 13 years at the time of the initial assessment
2. Receive a primary diagnosis of ADHD
3. If medicated for ADHD, be on a stable dose of medication for at least two weeks prior to the assessment
* Participating parents must

1. Self-identify as Latino
2. Be fluent in Spanish
3. Be able and willing to provide informed consent and comply with the study procedures, including being assigned either to standard or culturally-modified treatment
4. 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
Minimum Eligible Age

5 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Marquette University

OTHER

Sponsor Role lead

Responsible Party

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Alyson Gerdes

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Marquette University

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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HR-2871

Identifier Type: -

Identifier Source: org_study_id