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

Assistance Publique - Hôpitaux de Paris

Status

Completed

Conditions

Attention Deficit/Hyperactivity Disorder

Treatments

Other: Questionnaires

Behavioral: Self-hypnosis application

Study type

Interventional

Funder types

Other

Identifiers

NCT05741307

APHP220842

2022-A01509-34 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment

49 patients

Sex

All

Ages

7 to 12 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

49 participants in 2 patient groups

Patients 2

Experimental group

Description:

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.

Treatment:

Behavioral: Self-hypnosis application

Other: Questionnaires

Patients 1

Experimental group

Description:

Treatment:

Behavioral: Self-hypnosis application

Other: Questionnaires