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Completed

NCT Number: NCT02317692

ADHD Treatment for Latino Families

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.

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Key information

Conditions

ADHD Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

5 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marquette University

Milwaukee, Wisconsin, 53233, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Parent Training

Behavioral

Primary outcomes

  1. Engagement in Treatment - Treatment Completion (Number of Families Who Completed Treatment)

    Time frame: 8 weeks

    Number of families who completed treatment (recorded by clinician)

  2. Engagement in Treatment - Sessions Attended

    Time frame: 8 weeks

    Number of sessions attended by each family (recorded by clinician)

  3. Engagement in Treatment - Homework Completion (% of Completed Homework)

    Time frame: 8 weeks

    (recorded by clinician - homework was assigned every week and was expected to be returned at the next week's session)

  4. Acceptability of Treatment (Summary Score of Therapy Attitude Inventory)

    Time frame: 8 weeks

    Parental report of satisfaction with treatment (summary score of Therapy Attitude Inventory) Range=10-50; higher scores represent greater satisfaction (a better outcome)

Secondary outcomes

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

    Time frame: Baseline to 8 weeks

    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.

  2. Change in Parental Functioning (Maternal Parenting Stress)

    Time frame: 8 weeks

    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.

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

    Time frame: 8 weeks

    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.

Sponsors and collaborators

Lead sponsor

Marquette University

Other

Registry information

Official study title

Standard Versus Culturally-Modified ADHD Treatment

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 16, 2014
Registry last updated
Oct 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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