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

NCT ID: NCT05741307

Last Updated: 2025-09-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-04
• Study Completion Date: 2024-06-23

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.

Detailed Description

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 management of ADHD requires an effective multimodal approach to attention disorders and comorbid disorders. In France, the Haute Autorité de Santé recommends the combination of drug treatment with methylphenidate (as a second line or, for serious cases, from the first line) and a non-drug treatment such as behavioral therapies, cognitive remediation and psycho-educational support.

As part of this project, and more generally for the care of young ADHD patients, it is interesting to target a method that can be deployed in a relatively controlled way in addition to other non-drug measures and without contradicting them. Hypnosis is a technique that is already widely used in the treatment of pain. In the field of mental health, the clinical use of hypnosis is a relevant strategy to support self-regulation capacities in anxious children. Indeed, this technique offers an easily accessible experience of reducing arousal and dissociating internal physical sensations and perceptions, while promoting attentional focus towards the examination of new possibilities. The repeated use of self-hypnosis incorporating imaginary exposure facilitates the feeling of capacity for action ("empowerment") in the face of anxiety-provoking elements, reduces hyper-reactivity, and leads to the control of physiological reactivity.

In France, it is difficult for families to find structures for the care and monitoring of child's ADHD. The lack of speech therapists, the waiting list in public medical institution, the cost of follow-up by private psychologists, the lack of specialized structures are obstacles to care and increase the risk of pejorative evolution. In this context, the use at home by the child of a digitized self-hypnosis tool has all its interest.

The objectives of the study are 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 taking classical pharmacological load 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Patients 2

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.

Group Type: EXPERIMENTAL

Self-hypnosis application

Intervention Type: 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.

Questionnaires

Intervention Type: 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

Patients 1

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.

Group Type: EXPERIMENTAL

Self-hypnosis application

Intervention Type: 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.

Questionnaires

Intervention Type: 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

Interventions

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.

Intervention Type: BEHAVIORAL

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

Intervention Type: OTHER

Other Intervention Names

Hypnotidoo application; Conners III, CBCL and R-CMAS

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

URC-CIC Paris Descartes Necker Cochin

OTHER

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Catherine Grosmaitre, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Hôpital Necker-Enfants Malades

Paris, , France

Countries

France

References

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.

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 24938076 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21035021 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16442484 (View on PubMed)

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.

Reference Type: BACKGROUND

Other Identifiers

2022-A01509-34

Identifier Type: OTHER

Identifier Source: secondary_id

APHP220842

Identifier Type: -

Identifier Source: org_study_id