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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05741307
Other study ID # APHP220842
Secondary ID 2022-A01509-34
Status Recruiting
Phase N/A
First received
Last updated
Start date September 4, 2023
Est. completion date April 2025

Study information

Verified date February 2024
Source Assistance Publique - Hôpitaux de Paris
Contact Catherine Grosmaitre, PhD
Phone 1 44 49 45 67
Email catherine.grosmaitre@aphp.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The prevalence of Attention Deficit/ Hyperactivity (ADHD) varies between 3 and 10% depending on the studies. Comorbidities are frequently associated, in particular anxiety disorders. School, social and family consequences of ADHD can be major, especially in the presence of a comorbidity. The study goal is to evaluate, through questionnaires, the effect of self-hypnosis via a smartphone application, on the symptoms of inattention and anxiety in children with ADHD in addition to their treatment by methylphenidate. Parents and children complete the study questionnaires four times. - T0: at inclusion - T1 (T0+6 weeks): after 6 weeks of using the self-hypnosis application 5 days out of 7 for group 1 in parallel with the usual treatment / after 6 weeks of usual treatment for the group 2 - T2 (T0+8 weeks): after a wash-out period of 2 weeks (usual treatment only) for both groups - T3 (T0+14 weeks): after 6 weeks of use of the self-hypnosis application 5 days out of 7 for group 2 in parallel with the usual treatment / after 8 weeks of usual treatment for the group 1, following the 6 weeks of use of the application.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Self-hypnosis application
The Hypnotidoo application offers screenless self-hypnosis sessions for 5-12 year olds. Each session lasts 6 to 8 minutes and focuses on one of the following themes: stress and anxiety, sleep, daily troubles and discomforts, hypersensitivity, hyperactivity and difficulty concentrating, self-confidence, difficult life events, anger. Each session begins with breathing and refocusing work, followed by self-hypnosis through stories and metaphors suitable for children. The application will be used by patients in the context of research for 6 weeks, 5 days out of 7 in parallel with the usual treatment.
Other:
Questionnaires
Before and after (at T0, T1, T2 and T3) the 6-week period of use of the application and a wash-out period of 2 weeks (= usual treatment only), self- and hetero-questionnaires which constitute the gold standard for evaluating the symptoms of inattention and anxiety are proposed: Conners III, Child Behavior Checklist (CBCL) and Revised-Children's Manifest Anxiety Scale (R-CMAS). T0: inclusion T1: 6 weeks after T0 (inclusion) T2: 2 weeks after T1 T3: 6 weeks after T2

Locations

Country Name City State
France Hôpital Necker-Enfants Malades Paris

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (5)

Hiltunen, S., Virta, M., Salakari, A., Antila, M., Chydenius, E., Kaski, M., … Partinen, M. (2014). Better long-term outcome for hypnotherapy than for CBT in adults with ADHD: Results of a six-month follow-up. Contemporary Hypnosis and Integrative Therapy, 30, 118-134.

Kaiser P. Childhood anxiety and psychophysiological reactivity: hypnosis to build discrimination and self-regulation skills. Am J Clin Hypn. 2014 Apr;56(4):343-67. doi: 10.1080/00029157.2014.884487. — View Citation

Landier W, Tse AM. Use of complementary and alternative medical interventions for the management of procedure-related pain, anxiety, and distress in pediatric oncology: an integrative review. J Pediatr Nurs. 2010 Dec;25(6):566-79. doi: 10.1016/j.pedn.2010.01.009. Epub 2010 Mar 12. — View Citation

Richardson J, Smith JE, McCall G, Pilkington K. Hypnosis for procedure-related pain and distress in pediatric cancer patients: a systematic review of effectiveness and methodology related to hypnosis interventions. J Pain Symptom Manage. 2006 Jan;31(1):70-84. doi: 10.1016/j.jpainsymman.2005.06.010. — View Citation

Virta, M., Salakari, A., Antila, M., Chydenius, E., Partinen, M., Kaski, M., & Iivanainen, M. (2010). Hypnotherapy for adults with attention deficit hyperactivity disorder: A randomized controlled study. Contemporary Hypnosis, 27, 5-18.

Outcome

Type Measure Description Time frame Safety issue
Primary Change in severity of attention deficit The severity of attention deficit is assessed with the Conners 3 questionnary. It provide information's for information for 11 scales and includes 110 questions. Our research will focus on the T-score of inattention scale (mean=100, standard deviation=10). The higher the score is, the severed the symptom is. The change of the inattention scale T-score from base line at 6 weeks and 14 weeks will be used as primary outcome. Day 0, 6 weeks, 8 weeks, 14 weeks
Secondary Change in severity of anxiety with a self-questionnaire Assessment with the Revised-Children's Manifest Anxiety Scale (R-CMAS). The R-CMAS is a self-questionnaire of 28 anxiety items and 9 lying items. It provides scores for Total Anxiety and 4 subscales: Physiological Anxiety, Worry/Sensitivity, Social Concerns/Concentration, Lie Scale. The notation is binary: true/false. Our research will focus on anxiety total T-score (mean at 50, standard deviation at 10). The higher the T-Score is, the severed the symptom is. The change of the anxiety total R-CMAS T-score from base line at 6 weeks and 14 weeks will be used as seondary outcome. Day 0, 6 weeks, 8 weeks, 14 weeks
Secondary Change in severity of anxiety with a hetero-questionnaire Assessment with the Child Behavior Checklist inventory (CBCL). The CBCL provides information on 6 scales: Anxious/Depressed, Withdrawn/Depressed, Somatic Complaints, Social Problems, Thought Problems, Attention Problems, Rule-Breaking Behavior, and Aggressive Behavior. It includes 113 questions, noted from 0 to 2, depending on the presence of each symptom. Our research will focus on the T-score of the anxiety/Depressed scale (mean at 50, standard deviation at 10). The higher the T-Score is, the severed the symptom is. The change of the inattention scale T-score of the CBCL from base line at 6 weeks and 14 weeks will be used as seondary outcome. Day 0, 6 weeks, 8 weeks, 14 weeks
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