Clinical trial NCT05741307: Effect of a Self-hypnosis on Attention Disorders and Anxiety in Children With Attention Deficit/Hyperactivity Disorder
Official title: Effect of a Self-hypnosis Smartphone Application on Attention Disorders and Anxiety in Children With Attention Deficit/Hyperactivity Disorder (ADHD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit/Hyperactivity Disorder
Keywords: Attention Deficit/Hyperactivity Disorder
Anxiety
Hypnosis
Smartphone application
ADHD
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2023-02-23
Enrollment: 49
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change in severity of attention deficit
timeFrame: Day 0, 6 weeks, 8 weeks, 14 weeks
Secondary outcomes:
measure: Change in severity of anxiety with a self-questionnaire
timeFrame: Day 0, 6 weeks, 8 weeks, 14 weeks
measure: Change in severity of anxiety with a hetero-questionnaire
timeFrame: Day 0, 6 weeks, 8 weeks, 14 weeks
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Necker-Enfants Malades
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Catherine Grosmaitre, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
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.
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.
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.