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NCT03620344
ADHD/Me Bibliotherapy Study
NA trial testing ADH-Me Book and ADHD Informational Brochure in Attention Deficit Hyperactivity Disorder in 40 participants. Terminated before completion.
30 June 2019
Quick facts
| Lead sponsor | Children's Hospital Medical Center, Cincinnati |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | supportive care |
| Enrollment | 40 |
| Start date | 20 August 2018 |
| Primary completion | 30 June 2019 |
| Estimated completion | 30 June 2019 |
| Sites | 1 location across United States |
Drugs / interventions tested
- ADH-Me Book and ADHD Informational Brochure
- ADHD Informational Brochure Only
Conditions studied
- Attention Deficit Hyperactivity Disorder — all drugs for Attention Deficit Hyperactivity Disorder →
Sponsor
Children's Hospital Medical Center, Cincinnati
Who can join
Adults 7 to 10, any sex, with Attention Deficit Hyperactivity Disorder. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03620344
- Europe PMC full search
- ASCO Meeting Library
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Other Children's Hospital Medical Center, Cincinnati trials
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03620344 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Children's Hospital Medical Center, Cincinnati
- Last refreshed: 27 January 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03620344.
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