ADHD Treatment for Latino Families

NCT02317692 | Completed Results

• 1 other identifier: HR-2871
• Study Type: interventional
• Target: 147
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 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. 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.

Conditions

ADHD

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Change in ADHD Symptoms (Inattention Subscale of Disruptive Behavior Disorders Rating Scale)

  Baseline to 8 weeks

• Change in Parental Functioning (Maternal Parenting Stress)

  8 weeks

• Effects of Socioeconomic Status and Parental Acculturation on Treatment Outcomes (Parental Report)

  8 weeks

Study Arms (2)

Standard ADHD parent training

ACTIVE COMPARATOR

8 sessions of evidence-based parent training plus school intervention

Behavioral: Parent training

Culturally-modified ADHD parent training

EXPERIMENTAL

8 sessions of culturally-modified parent training plus school intervention

Behavioral: Parent training

Interventions

Parent training BEHAVIORAL

Culturally-modified ADHD parent training; Standard ADHD parent training

Eligibility Criteria

• Age: 5 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Children must not meet DSM-5 diagnostic criteria for Intellectual Disability, Autism Spectrum Disorder, or a psychotic disorder

Sponsors & Collaborators

• Marquette University: lead

Study Sites (1)

Marquette University

Milwaukee, Wisconsin, 53233, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Alyson Gerdes
• Organization: Marquette University

alyson.gerdes@mu.edu

414-288-6145

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 9, 2014
• First Posted: December 16, 2014
• Study Start: January 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: October 23, 2017
• Results First Posted: October 23, 2017

Record last verified: 2017-05

Locations

US (1)