ANZCTR - Registration

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12623000873628

Ethics application status

Approved

Date submitted

26/06/2023

Date registered

15/08/2023

Date last updated

14/09/2023

Date data sharing statement initially provided

15/08/2023

Type of registration

Prospectively registered

Titles & IDs

Public title

Preliminary study of The Feelings Program for Adolescents with neurodevelopmental conditions delivered in a group clinic-based setting or parent home-based setting to explore feasibility, participant experience and the effect on social emotional domains, wellbeing and mental health concurrent with delivery of the digital version of this intervention.

Scientific title

Preliminary study of The Feelings Program for Adolescents with neurodevelopmental conditions delivered in a group clinic-based setting or parent home-based setting to explore feasibility, participant experience and the effect on social emotional domains and mental health concurrent with delivery of the digital version of this intervention.

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Cerebral Palsy

Mild Intellectual Disability

Autism Spectrum Disorder

Condition category

Condition code

Neurological

Other neurological disorders

Mental Health

Learning disabilities

Mental Health

Autistic spectrum disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The Feelings Program for Adolescents (TFP-A) Digital Version was adapted from the Westmead Feelings Program (WFP) by the WFP author group for an adolescent target audience, with a diagnosis of autism spectrum disorder and co-occurring mild intellectual disability (ID).
In these two separate single arm, multi-centre, with-in subject intervention studies, in 2024, TFP-A will be delivered to adolescents with neurodevelopmental conditions (NDCs) who are enrolled in a secondary school and who have been identified as potentially benefiting from a social-emotion wellbeing program.
Based on previous studies we have conducted in over 65 NSW schools and 8 Aspect Schools, TFP-A will be delivered in either small groups in a clinic setting, or in a home-based setting with the support of a parent. Recent pilot studies of TFP-A with autistic adolescents with a range of cognitive abilities indicated that it was feasible to conduct the program in a clinic and school-based setting, and was beneficial in improving emotional competence in adolescents. However, no such program has been developed to support adolescents with a broader range of NDCs. Furthermore, in the Cerebral Palsy (CP) community, individuals, parents and peak bodies such as Cerebral Palsy Alliance, recognised a need for a similar program for adolescents with motor, communication and cognitive difficulties, such as CP. CPA will be asked to nominate staff to be training as facilitators of TFP-A to assist in the implementation of TFP-A in the clinic-setting. CPA staff will have Mental Health First Aide training and experience supporting adolescents with CP in a group environment. Co-facilitators will also be trained to provide positive behaviour support and learning support.
The CPA facilitators will be trained by authors of TFP-A to become facilitators of TFP-A. Facilitator training will include a total of 10 hours of training (via zoom) held over 4 days across 12 months. Training will include also include asynchronous learning (watching videos and reading materials. The 10 hours of synchronous learning will start with a 4 hour training session held in late 2023. In this session facilitators will be provided with an introduction to emotional development framework and TFP-A. At the end of the training facilitators will be asked to complete additional reading and familiarise themselves with TFP-A online content. Facilitators will be asked to complete an online quiz, and submit a video demonstrating a mock TFP-A (as assigned by the trainer). The quiz and video demonstration will be assessed by the trainer. To pass the initial training, staff need to achieve 80% or above on an online quiz and demonstrate competence in delivering the program through a 10min video demonstration task. If they are unsuccessful they will be provided with feedback and an opportunity to re-submit. In early 2024, before the commencement of the program, facilitators will attend an additional 2 hours training. In this session the trainer will provide a course re-fresher, and also provide feedback to the facilitators based on their video demonstrations. This session will also provide an opportunity for the facilitators to ask additional clarifying questions. The final 4 hours of training are provided to the facilitators at the end of Module 1 (2 hours) and Module 2 (2 hours). In these session the trainer will review the upcoming module, and also provide the facilitators with an opportunity to ask questions.
The manualised program provides step by step instructions on how to run the group and includes paper-based and digital-based visual supports and audio-video content. TFP-A consists of 18 sessions, each of 60 minute during, held across the year. It is expected that the program will start in Term 1, 2024 and will be completed by Term 4, 2024. A booster / review lesson will be held in Term 1, 2025. TFP-A is grouped into 3 modules covering 1) identifying and expressing emotions, 2) problem solving and perspective taking and 3) emotional regulation. A booster/review session will be held 3 months after the last clinical session and is a review and consolidation of the material already covered in the program. The booster session will be for 60 minutes. Co-facilitators will be asked to complete an implementation and attendance checklist of during the sessions as a measure of fidelity.

In the group intervention there may be between 3-6 adolescents in each TFP-A group. In the home-based program adolescents will access TFP-A with support from their parent. In TFP-A lessons, participants will engage in a lesson which includes watching videos, discussing the content of videos and completing worksheets based on their own examples. For example in lesson 1 adolescents watch a video to learn about pleasant and unpleasant feelings, they then have a class discussion on different pleasant and unpleasant feelings, followed by completing a worksheet that consolidates their learning. They are then asked to complete a worksheet based on their own example. At the end of each lesson students are given takeaway tasks based on the same worksheet. It is expected that worksheet will require 15 minutes to complete, with the support of a parent / carer in the home environment. In the clinic program all worksheets will be reviewed by the facilitators and co-facilitators to ensure that students are completing the worksheets accurately, and that students understand the material being taught. In the home-based program, parents attend parent sessions where they present their child's material for group discussion and evaluation. There are consolidation sessions at the end of each module which can provide facilitators / parents time to support additional learning. There are two versions of worksheets available for facilitators to use, a basic version and a more complex version. All adolescents will be provided with both worksheets in the first module, however based on progress and accurate completion of the worksheet, adolescents will be provided with the worksheet that best meets their learning needs in Module 2 and Module 3 (ie reduced cognitive content). Parents are provided additional support in parent sessions when making this decision.
In addition to the adolescent TFP-A, there are also separate online parent groups and online parent content. Asynchronistic online parent program will include videos, written resources and guidance to develop their skills as emotion coaches for their child. There will also be synchronistic opportunities for parents to meet with other parents in either face to face or online sessions, facilitated by TFP-A authors and CPA facilitators. The aim of the parent sessions is also to build parent capacity and confidence in supporting their child's emotional needs in a home and community context. This will include using the strategies and language taught in TFP-A. Parents will be invited to attend a face to face session (or online session if required for geographic, family or general health recommendations reasons). All parents will be provided training on the purpose of TFP-A and their role as an emotion coach. They will be introduced to the online training program and taught how to access the program and the elements covered over the year in TFP-A. Each fortnight over the course of TFP-A (Term 1, Term 2 and Term 3) parents will be asked to complete short online training modules, each one lasting for 10-30 minutes. There are 10 modules in total covering generalisation of skills in autism, emotion communication, recognising emotion body signs, recognising emotion-based behaviour, linking situations, thoughts and feelings, problem solving, perspective taking and a range of emotion regulation strategies. There will also be an additional 3 parent training session for parents in the home-based program. Content will include the role of the parent regarding parent attunement, modelling emotion regulation, mindfulness, parenting teenagers and trouble shooting delivering the program at home. Each online training module will have a learning check with 2-3 questions to assess if a parent has grasped the concepts being taught.
Parents will be asked to attend a group training session at the start of each Term to provide them with additional support and opportunity to practice new skills with the facilitator. Face to face or online sessions will be for 1 hour duration. It is asked that parents complete all the online training material and attend the 3 face to face parent sessions. Attendance records will be kept of group sessions and progress of online material will be accessed through the learning management system (LMS).
Each family will also nominate a teacher to be a school-based emotion coach. Teachers will have access to the online learning material for TFP-A including worksheets and videos of how the worksheets can be incorporated into a school setting.
Due to the small sample size, the aim of this study is to explore the feasibility of the each program, but not to compare the modes of administration to each other. Allocation to the clinic or home based program will be based on a number of factors. Firstly, in the clinic based program, adolescents will need to be willing and able to attend and participate in the group program. This will include factors such as geographic location, adequate attention and behaviour skills to engage in a group setting, and communication skills which allow for meaningful participation. The recruitment strategy includes communicating the study through the CP NSW Register. Families that first hear of the study may self select either group or home based program based on the information above (which is also included in the parent information sheet). Staff at CPA and in the professional networks of SCHN may also assist in recruitment through approaching families that they believe would be interest in the study. Staff may also assist parents in selecting group or home based option. However, through the background questionnaire and eligibility assessment, all adolescent participants will be screened for entry to the group based program. If a family is interested in the study, but the adolescent does not meet the above criteria, the family will be offered the home program.

Intervention code [1]

Treatment: Other

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Determine if the TFP-A is feasible based on composite feedback from adolescents, their parents and faciliators in both a clinic and home-based setting. Feasibility will be assessed by a researcher-developed questionnaire, with adolescent, parent and facilitator versions. Feasibility will be reported based on a combination of adolescent, parent and facilitator outcomes into a singular outcome Feasibility as reported by adolescents will be measured on a 3-point Likert Scale, where feasibility is indicated with 80% or more of respondents providing a positive score. Feasibility as reported by parents and teachers will be measured on a 5-point Likert Scale, where 80% score four or five to indicate feasibility. These component outcomes will be reported as a singular outcome.

Timepoint [1]

Feasibility questionnaire conducted at the end of each of the 3 modules and 6 month follow up booster session with adolescents (Term 1, Term 2 and Term 3, 2024 & Term 1, 2025)
Feasibility questionnaire conducted at the end of 18 sessions (post-treatment, end of Term 4, 2024) and at 3 month follow up with parents and facilitators (end of Term 1, 2025).

Primary outcome [2]

Evaluate changes in adolescent participants in individually developed social-emotional goals concurrent with the delivery of TFP-A.

Goal Attainment Scale (GAS) goals will be individually developed in collaboration with parents for each participant, including two goals in the home. The GAS goal is developed to create a measurable and achievable goal for each participant with defined outcomes of current skill (-1), expected improvement (+1), greater than expected improvement (+2), and decline of skill (-3) and less than expect improvement in skill (0). This scale is developed with the researcher and teacher.

Change will be described on a case-by-case basis using pre- and post-treatment scores, with a score of -1 meaning there was no change, 1 meaning there was improvement as expected, and 2 meaning there was a greater than expected improvement. Conversely a score of -2 would indicate a decline in skill area and -1 would be a smaller than expected improvement in skill. Percentage change scores will also be described.

Timepoint [2]

Baseline - pre-treatment (By Term 1 2024)
Post-treatment (after 18th session, at the end Term 4, 2024)

Primary outcome [3]

Evaluate changes in adolescent participants in emotions competence concurrent with the delivery of TFP-A.

Behavioural Emotional Competency Child and Adolescent Task (BECCA Task; Wong, Gardner, Ford & Dossetor, 2022) is an observation based assessment of emotional competence including use of emotion communication, emotion regulation and emotional perspective taking.

Change on sub-scales in the measure will be described on a case-by-case basis using pre- and post-treatment scores. Percentage change scores will also be described.

Timepoint [3]

Baseline - pre-treatment (By Term 1 2024)
Post-treatment (after 18th session, at the end Term 4, 2024)

Secondary outcome [1]

Evaluate changes in adolescent participants in parent and teacher reported emotions competence concurrent with the delivery of TFP-A and at 3 month follow up..

Emotions Development Questionnaire (EDQ; Wong, Lopes & Heriot, 2009) has been previously designed by researchers exploring earlier studies to assess change in the level of emotional competence for participants, as reported by parents and teachers.

Change on the EDQ will be described on a case-by-case basis using pre- and post-treatment, and 3 month follow up scores as a total score and also in each of the four domains (emotional expression, emotion regulation, problem solving and perspective taking). Percentage change scores will also be described.

Timepoint [1]