ADHD/Me Bibliotherapy Study

NCT ID: NCT03620344

Last Updated: 2020-01-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-20
• Study Completion Date: 2019-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

ADH-Me Book and ADHD Informational Brochure

Intervention Type: OTHER

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

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.

Group Type: SHAM_COMPARATOR

ADHD Informational Brochure Only

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

ADHD Informational Brochure Only

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• English speaking
• Meet ADHD criteria based on ADHD evaluation

Exclusion Criteria

-

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Center for ADHD, Cincinnati Childrens Hospital Medical Center

Cincinnati, Ohio, United States

Countries

United States

Other Identifiers

2017-4815

Identifier Type: -

Identifier Source: org_study_id