E-PACT: Randomised Trial of Parenting Acceptance and Commitment therapy for Parents of children with neurodevelopmental disabilities
E-PACT: Randomised Trial of Parenting Acceptance and Commitment Therapy for Parents of children diagnosed with or with increased chance of neurodevelopmental disability or developmental delay
The University of Queensland
300 participants
Feb 26, 2024
Interventional
Conditions
Summary
This proposal is a type-1 hybrid randomised controlled trial, focussing on effectiveness and implementation. Our aim is to grow the capacity of parents of children with neurodevelopmental disabilities (NDD) to continue to effectively implement and manage ongoing interventions for their children, with an easily translatable online/telehealth intervention: E-PACT. Parent capacity is underpinned by multiple factors including physical and mental health and is associated with multiple child outcomes. Our primary outcome is parent capacity itself, specifically the core parenting competency: emotional availability measured on the Emotional Availability Scale (EAS). Secondary outcomes include parent and child physical and mental health. Tertiary outcomes will measure the cost and consequences, barriers and facilitators of E-PACT delivery compared to Care as usual to inform implementation. We will conduct a phase III RCT of an online/telehealth intervention E-PACT with 300 families of children with NDD. This is a two-arm RCT in which families of a child (0-10 years) with a diagnosis of any NDD or at identified increased likelihood of a NDD will be randomly assigned to E-PACT or Care As Usual (CAU) with follow-up until 6 months post baseline. All families will complete pre-intervention assessment at baseline (T1), post-intervention assessment (T2), and 6 months follow up (T3 6 months post baseline). Families in the CAU group will then be provided with E-PACT after completion of the six months follow up (wait-list control).
Eligibility
Inclusion Criteria1
- Families must have a child 0-10 years of age with either a diagnosis of any NDD (e.g., Cerebral Palsy, Autism, Fetal Alcohol Spectrum Disorder) or at identified increased likelihood of a NDD on the basis of one of the following: (1) a diagnosis of developmental delay in two or more domains (i.e., gross motor, fine motor, language, or personal/social), (2) an increased likelihood of Cerebral Palsy as established through the General Movements Assessment (GMA) or Hammersmith Infant Neurological assessment, (3) an increased likelihood of autism as established through the Social Attention and Communication Surveillance Revised (SAC-R) or the ASDetect mobile application, or (4) identified as being at risk of FASD in accordance with the Australian Guide to Diagnosis of FASD. These inclusions are consistent with the latest practice in international Clinical Practice Guidelines for the early identification of Cerebral Palsy, Autism Spectrum Disorder and Fetal Alcohol Spectrum Disorder.
Exclusion Criteria2
- Potential parent participants who are unable to understand the written information sheet will be excluded from the study, as the intervention includes materials written in the English language, and the study requires participants to complete sets of online questionnaires written in the English language. Any families who would be excluded from the study on the basis of language will be referred to other services as appropriate.
- The PACT Online intervention and study assessment protocols will all be conducted online. As such, families who do not have sufficient internet access to participate in the study, either in their own homes or elsewhere, will also necessarily be ineligible and referred to other services as appropriate.
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Interventions
E-PACT is an online/telehealth parent support intervention developed in partnership with parents and focussed on growing parent capacity. E-PACT (“Parenting with Acceptance and Commitment Therapy”) was developed grounded in acceptance and commitment therapy (ACT), a type of cognitive behavioural therapy (CBT) that targets psychological flexibility: the “ability to persist or change one’s behaviour, with full and flexible awareness of the situational context and one’s own present-moment experience, in the service of chosen values”. Core to ACT is acknowledgement of the universality of suffering, and the importance of living a meaningful life through effective action and focusing on what works, themes that resonate for parents of children with neurodevelopmental disabilities (NDD). E-PACT will support parents to grow parent capacity by cultivating flexible, sensitive, and effective parenting through developing: • Effective strategies for teaching new skills, and encouraging positive behaviour • Effective strategies for managing misbehaviour • Effective strategies for interacting with the wider community • Awareness of their own and their child’s (developing) values • Awareness of effective action, i.e., what works • Insightfulness, understanding the child’s perspective • Experiential acceptance, the ability to live with distressing emotions, cognitions, and memories as they arise, and continue to focus on effective action • Acceptance of their child and their child’s emotions, cognitions etc. • Self-compassion & achievable self-care repertoires It will include an EdX course and clinician consultations. E-PACT EdX course: 12-week EdX course, includes videos, text, multiple choice questions, real life activities (e.g., practising mindfulness during a parent-child interaction), and a discussion board facilitated by the E-PACT clinicians. The course contains six modules (one module per fortnight across 12-weeks), with modules taking approximately one hour each to complete. E-PACT is delivered via the edX platform, freely available and fully supported at the University of Queensland. Module engagement will be tracked via participants' completion of questions related to program feasibility, appropriateness, and acceptability shown at the end of each module. Clinician Support: One-on-one clinician consultations (30 minutes per fortnight across the 12-week course) will support parents in understanding and acting on E-PACT content, taking a flexible goal-directed approach. Clinician consultations will focus on: parental goals, parental application in real life, overcoming obstacles, and integrating flexibility into parent-child interactions. Clinician consultations will be conducted via ZOOM. They will be recorded and assessed for adherence to protocol and session attendance logs will be kept. Parents will choose three goals for change (i) a parent-child relationship or parenting goal, (ii) a parental self-care or health behaviour goal, and (iii) a child behaviour/adjustment goal. E-PACT is supported by trained allied health clinicians providing individualised feedback and additional support to specific families. It thus offers a translatable and scalable universal online support with additional telehealth components for families who need it.
Locations(1)
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ACTRN12623000612617