ADHD/Me Bibliotherapy Study

NCT03620344 | Terminated

• 1 other identifier: 2017-4815
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Attention-deficit/hyperactivity disorder (ADHD) is one of the most common neurodevelopmental disorders of childhood. It affects approximately 8% of school aged children and is characterized by persistent symptoms of inattention and/or hyperactivity/impulsivity. Typical ADHD assessments primarily involve interviewing the parents and gathering rating scales from parents and teachers. Feedback regarding diagnosis, clinical conceptualization, and treatment recommendations is usually provided by the clinical staff to the child's parents in the absence of the child. Hence, the ADHD diagnosis and repercussions of that diagnosis are often left unexplained to the child. Research has shown that bibliotherapy is an effective educational tool that can be used to help parents discuss ADHD diagnosis and treatment with their child. The aim of this study is to conduct a randomized trial in which tools for parents who are getting their elementary-aged (7 to 10-year-old) children evaluated for ADHD are explored. The evaluations (N=60) will be conducted at the Center for ADHD at Cincinnati Children's Hospital Medical Center (CCHMC) in Cincinnati, OH. Half of the families (n=30) will be randomly assigned to the intervention group, where they will be provided with the child-focused "ADH-Me!" book during the feedback session, and the remaining half will not receive it. All participants will receive a booklet with general information about ADHD and a list of recommendations from the clinicians. Approximately 3 months after their feedback sessions, follow-up surveys will be conducted via telephone to question the parents and children about their ADHD knowledge, as well as about whether they had followed up on the clinicians' recommendations. It is hypothesized that providing families with the ADH-Me! book will increase families' knowledge about ADHD and facilitate the family following up on treatment recommendations.

Conditions

Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (1)

• ADHD Knowledge and Opinion Survey - Revised

  The knowledge portion of the AKOS-R, which consists of 15 true/false items, was modified by the research team for the 7 to 10-year-old children that will participate in this study. The overall readability of the survey was reduced from a 6th grade to a 4th grade level.

  3 months after ADHD evaluation feedback session

Secondary Outcomes (2)

• Decision-Making Involvement Scale - Parent Report

  3 months after ADHD evaluation feedback session

• Decision-Making Involvement Scale - Youth Report

  3 months after ADHD evaluation feedback session

Study Arms (2)

ADH-Me Book

EXPERIMENTAL

Families in both conditions will be told that they are receiving additional reading materials to help them and their child better understand the ADHD condition and the available options for treating ADHD. Families in both groups will receive the "Understanding ADHD: Information for Parents About ADHD" brochure. Families assigned to this condition will also receive the ADH-Me! book. Written by a pediatrician and health literacy expert, ADH-Me! is an accessible, rhyming narrative that describes an empathetic journey from the perspective of a child learning to live and succeed with ADHD. The book is intended to help families know what to expect from diagnosis through all stages of treatment, while attempting to foster love and support.

Other: ADH-Me Book and ADHD Informational Brochure

No ADH-Me Book

SHAM COMPARATOR

Families in both conditions will be told that they are receiving additional reading materials to help them and their child better understand the ADHD condition and the available options for treating ADHD. Families in both groups will receive the "Understanding ADHD: Information for Parents About ADHD" brochure.

Other: ADHD Informational Brochure Only

Interventions

ADH-Me Book and ADHD Informational Brochure OTHER

"Understanding ADHD" information brochure published by American Academy of Pediatrics and a children's book about ADHD condition

ADH-Me Book

ADHD Informational Brochure Only OTHER

"Understanding ADHD" information brochure published by American Academy of Pediatrics

No ADH-Me Book

Eligibility Criteria

• Age: 7 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• English speaking
• Meet ADHD criteria based on ADHD evaluation

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Center for ADHD, Cincinnati Childrens Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2018
• First Posted: August 8, 2018
• Study Start: August 20, 2018
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: January 27, 2020

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)