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Trial registered on ANZCTR

Registration number

ACTRN12618000986279

Ethics application status

Approved

Date submitted

12/04/2018

Date registered

12/06/2018

Date last updated

13/06/2018

Type of registration

Prospectively registered

Titles & IDs

Public title

Early Parenting Acceptance and Commitment Therapy ‘Early PACT’ for parents of infants with cerebral palsy

Scientific title

Early Parenting Acceptance and Commitment Therapy ‘Early PACT’ for parents of infants with cerebral palsy: A randomised controlled trial

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Early PACT

Linked study record

Health condition

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

Cerebral Palsy

Mental Health

Condition category

Condition code

Neurological

Other neurological disorders

Mental Health

Other mental health disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Early PACT is a parenting intervention grounded in Acceptance and Commitment Therapy for parents of children with Cerebral Palsy. Early PACT includes ACT technologies already established in an RCT as effective with families of children with CP, including mindfulness, experiential acceptance and cognitive defusion (Whittingham et al., 2014; Whittingham et al., in press; Whittingham, Sanders, et al., 2013). It includes some techniques from the established parenting literature but focuses on strategies to enhance the parent-child relationship and promote parental emotional responsiveness. Early PACT is provided as an online course via the edX platform, an open source course management system created by founding partners Harvard and MIT (www.edx.org/). The course incorporates virtual written text, video presentations, screen-based interactive activities, journal activities, reflections, guided experiential and mindfulness exercises and participation in a moderated discussion board. The course is offered to participants as three modules plus a review session four weeks after the final module. Modules are scheduled to be completed each fortnight, with a four-week break after that to allow for practice of the materials from the course (10 weeks total), with flexibility to move through content. Modules contain content exploring the parent’s values, thoughts and feelings, mindfulness techniques, ways to meet their child’s needs, and exercises for learning compassion. Modules contain videos for parents to watch and reflective exercises on what they have been shown gearing toward practice with their own child. Adherence to the course is monitored via website analytics, the coordinator can access information on whether participants have completed the course and assessments. Regular contact via phone with the parent will also occur to monitor their progress and adherence to the study.

Intervention code [1]

Behaviour

Comparator / control treatment

This study is a Randomised Control Trial (RCT) following CONSORT (Consolidated Standards of Reporting Trials) guidelines. Parents of infants aged < 24 months C.A with CP will be randomly allocated to one of two groups:
(1) Immediate allocation to Early Parenting Acceptance and Commitment Therapy (Early PACT) in the form of the online course
(2) Wait-list control (usual-care); Early PACT will commence after a 3 month waiting time
Follow up will occur at 6 months post intervention (retention). All families will receive the intervention.
Usual care includes the medical, physiotherapy, or occupational therapy support the child is receiving and and self-driven or social supports the parents may have sought.

Control group

Active

Outcomes

Primary outcome [1]

Emotional availability within the parent-child relationship, assessed by the Emotional Availability Scales, (Biringen, Fidler, Barrett, & Kubicek, 2005; Biringen, Robinson, & Emde, 1998).

Timepoint [1]

Conducted at baseline, post review (ten weeks after course commencement) [primary time point], and at six-months post intervention follow up

Primary outcome [2]

Parent's perception of emotional availability within the parent-child relationship assessed by the Emotional Availability-Self Report (Vliegen, Luyten, & Biringen, 2009).

Timepoint [2]

Conducted at baseline, post review (ten weeks after course commencement) [primary time point], and at six-months post intervention follow up.

Secondary outcome [1]

Parental psychological flexibility as measured by the Acceptance and Action Questionnaire (Bond et al., 2011).

Timepoint [1]