ADHD/Me Bibliotherapy Study

The Effect of Bibliotherapy on Parent and Child Knowledge of ADHD and Treatment Follow-up

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.

Study Overview

• Status: Terminated
• Conditions: Attention Deficit Hyperactivity Disorder
• Intervention / Treatment: Other: ADH-Me Book and ADHD Informational Brochure; Other: ADHD Informational Brochure Only

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Center for ADHD, Cincinnati Childrens Hospital Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 10 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• English speaking
• Meet ADHD criteria based on ADHD evaluation

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: ADH-Me Book; 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; "Understanding ADHD" information brochure published by American Academy of Pediatrics and a children's book about ADHD condition
SHAM_COMPARATOR: No ADH-Me Book; 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; "Understanding ADHD" information brochure published by American Academy of Pediatrics

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decision-Making Involvement Scale - Parent Report	The DMIS is a 30-item measure completed by parents that was developed to assess the degree to which children and adolescents (ages 8 to 19 years) are involved in decisions having to do with their chronic illness management.	3 months after ADHD evaluation feedback session
Decision-Making Involvement Scale - Youth Report	The DMIS is a 30-item measure completed by children that was developed to assess the degree to which children and adolescents (ages 8 to 19 years) are involved in decisions having to do with their chronic illness management.	3 months after ADHD evaluation feedback session

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 20, 2018
• Primary Completion (ACTUAL): June 30, 2019
• Study Completion (ACTUAL): June 30, 2019

Study Registration Dates

• First Submitted: July 20, 2018
• First Submitted That Met QC Criteria: August 6, 2018
• First Posted (ACTUAL): August 8, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 27, 2020
• Last Update Submitted That Met QC Criteria: January 22, 2020
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity
• Other Study ID Numbers: 2017-4815

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to share.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No