ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12616001414404

Ethics application status

Approved

Date submitted

20/09/2016

Date registered

11/10/2016

Date last updated

13/04/2024

Date data sharing statement initially provided

21/08/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

A pilot intervention for attention, memory, and social problems after an acquired brain injury in children and adolescence.

Scientific title

A pilot intervention program for cognitive and social sequelae following Acquired Brain Injury in childhood and adolescence.

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

U1111-1184-7768

Trial acronym

Amat-c

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Acquired brain injury

Condition category

Condition code

Injuries and Accidents

Other injuries and accidents

Neurological

Other neurological disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The Amsterdam Memory and Attention Training for children (Amat-c) is a cognitive training program for enhancing children’s attention, memory, and executive functioning (EF) skills. This is a restorative or direct intervention that is designed to treat the consequences of ABI, and requires an initial evaluation to identify impaired abilities. The child is trained, using specific exercises focusing on deficient cognitive abilities, in an attempt to improve these skills, as well as to impact more generally on cognitive functions.

The task undertaken by the child are presented in three phases:

Phase 1—Sustained attention. Training methods focus on learning to concentrate on one task for a period of time. Example: Listening to the clock: The clock’s ticking is counted. The distance from the clock is increased and the task repeated until the child is not able to complete the task. The first and the final distance from the clock are measured.

Phase 2—Selective attention. Focused (e.g. ignore distraction) and divided attention (e.g. focusing attention quickly and flexibly). Example: ABCDE Method: The Child is taught the ABCDE Method for approaching a task. A, Appreciating; B, Being Critical; C, Concentrating, D, Deep Thinking, E, Evaluating.

Phase 3—Mental tracking and memory. Techniques to assist memory, including repetition, coding/sorting and visual imagery. Example: Memory—Repeating and Sorting: The child is involved in tasks that require repetition of information and sorting of information in order to enhance memory skills.

The Amat-c will be administered to participating families in the treatment group for a period of 18 weeks. Each week will be preceded by a 1hour clinician-support session. During these sessions, a clinician will call participating families via a video call to explain the techniques and instructions for the Amat-c activities for that week. The clinician will also address any concerns arising from the previous week’s activities (commencing from week two).

Following this, the Amat-c program will be delivered by a parent for the rest of the week, in a daily 30 minute session. Parents will coach this session using relevant sections the Amat-c Handbook provided for the respective week’s activities.

Adherence to the intervention will be monitored during the weekly call sessions with the clinician. Here, specific questions will be asked as to whether the exercises were completed and any potential challenges associated with each exercise will be addressed. In addition, we will evaluate adherence to the protocol by assessing the parent’s responses to questions about their likes and dislikes for each week’s activities, entered in a section of the workbook. All workbooks completed by the parent and child during the weekly activities will be collected at the post-intervention outcome assessment session, and will be another source of evaluation of adherence to the intervention.

Intervention code [1]

Treatment: Other

Intervention code [2]

Rehabilitation

Intervention code [3]

Behaviour

Comparator / control treatment

An active control group with ABI will be included in this study. This group will be asked to read the content of a psycho-education booklet on common behaviour problems associated with childhood ABI. This booklet is designed for the purpose of this study and will include sections on headache, fatigue, sleep disturbances, dizziness and emotional problems, as well as sections on how parents can assist their child in each of these domains. Parents will be required to read this booklet.

Subsequently, a clinician will conduct a weekly video or audio call to discuss these topics and any potential problems encountered by the family in a given domain. Each weekly call will involve a one-on-one session with the clinician and will be for a maximum of 1hour.

The control group will only be administered the Amat-c program once all data collection is complete and the feasibility and efficacy of the program is confirmed. Thus, post outcome assessment. This is expected to be approximately 9 months after the intervention group has completed the program.

Control group

Active

Outcomes

Primary outcome [1]

Memory: assessed using the mean scores on pre-selected subtests of the Children’s Memory Scale)

Timepoint [1]

Screening, immediately post-intervention, and at 6months post intervention.

Primary outcome [2]

Attention: assessed using the mean scores on pre-selected subtest of the Everyday Attention for Children (TEA-Ch)

Timepoint [2]

Screening, immediately post-intervention, and at 6months post intervention.

Secondary outcome [1]

Adaptive Behabior: assessed with the Vineland Adaptive Behaviour Scales- Second Edition (Vineland-II) - Parents form

Timepoint [1]