Effect of a Self-hypnosis on Attention Disorders and Anxiety in Children With Attention Deficit/Hyperactivity Disorder

NCT05741307 | Completed

• 2 other identifiers: APHP2208422022-A01509-34
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Attention Deficit/Hyperactivity Disorder

Keywords

Attention Deficit/Hyperactivity Disorder; Anxiety; Hypnosis; Smartphone application; ADHD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in severity of anxiety with a self-questionnaire

  Day 0, 6 weeks, 8 weeks, 14 weeks

• Change in severity of anxiety with a hetero-questionnaire

  Day 0, 6 weeks, 8 weeks, 14 weeks

Study Arms (2)

Patients 2

EXPERIMENTAL

Patient aged 7 to 12 with a diagnosis of ADHD made by a child psychiatrist or neuropediatrician and followed by the child psychiatry department - Reference Center for Language and Learning Disorders of the Necker Enfants Malades Hospital. These patients will use of the self-hypnosis application 6 weeks after inclusion : from T2 to T3.

Behavioral: Self-hypnosis application; Other: Questionnaires

Patients 1

EXPERIMENTAL

Patient aged 7 to 12 with a diagnosis of ADHD made by a child psychiatrist or neuropediatrician and followed by the child psychiatry department - Reference Center for Language and Learning Disorders of the Necker Enfants Malades Hospital. These patients will use of the self-hypnosis application at inclusion : from T0 (inclusion) to T1.

Behavioral: Self-hypnosis application; Other: Questionnaires

Interventions

Self-hypnosis application BEHAVIORAL

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.

Also known as: Hypnotidoo application

Patients 1; Patients 2

Questionnaires OTHER

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

Also known as: Conners III, CBCL and R-CMAS

Patients 1; Patients 2

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patient of French mother tongue, aged 7 to 12 with a diagnosis of ADHD made by a child psychiatrist or neuropediatrician according to DSM-5 criteria
• Patient treated with methylphenidate and followed by the child psychiatry department - Reference Center for Language and Learning Disorders of the Necker Enfants Malades Hospital
• Information and consent of holders of parental authority and of the patient

You may not qualify if:

• Presence of an intellectual disability
• Presence of an autism spectrum disorder

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Hôpital Necker-Enfants Malades

Paris, 75015, France

Location

Related 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.

  BACKGROUND

• 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.

  PMID: 24938076 BACKGROUND

• 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.

  PMID: 21035021 BACKGROUND

• 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.

  PMID: 16442484 BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Anxiety Disorders

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Catherine Grosmaitre, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2022
• First Posted: February 23, 2023
• Study Start: September 4, 2023
• Primary Completion: June 23, 2024
• Study Completion: June 23, 2024
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)