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Efficacy of the Take a Breath Parent Program: A Randomised Controlled Trial for parents of children with a serious childhood illness/injury.

For parents of children with a serious childhood illness/injury, is the Take a Breath parent program, compared with treatment as usual efficacious in enhancing parental wellbeing and reducing psychosocial distress?

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12611000090910
Acronym
TAB RCT
Enrollment
81
Registered
2011-01-25
Start date
2014-01-15
Completion date
2016-09-30
Last updated
2025-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This project will evaluate the efficacy of the Take a Breath Parent Program, which targets parents from three months following a traumatic event (their child's diagnosis of a serious childhood illness/injury). The overall aim is to assess if the Take a Breath Parent program leads to improvements in psychosocial distress for parents exhibiting early signs of posttraumatic stress. Specifically the trial will assess if participation results in: improvements in parental psychological flexibility, committed actions, valued living and quality of life and reductions in parental posttraumatic stress symptoms, experience of the illness/injury as distressing, and referrals to additional supports (e.g., mental health/counselling). Secondly improvements in child quality of life and child behaviour, family functioning and postive outcomes of the illness/injury will be assessed.

Interventions

Arm 1: Five weekly consecutive parent mediated group sessions (with up to 8 parents, 1.5 hours in duration each, totaling 7.5 hours) for parents of children with serious childhood illnesses/injuries (with one booster session - 1.5 hours in duration one month following the fifth session). The program is based on social learning principles and will utilize an acceptance and commitment therapy approach. Arm 2: Wait list control - these parents will receive the Take a Breath Intervention (Arm 1) app

Arm 1: Five weekly consecutive parent mediated group sessions (with up to 8 parents, 1.5 hours in duration each, totaling 7.5 hours) for parents of children with serious childhood illnesses/injuries (with one booster session - 1.5 hours in duration one month following the fifth session). The program is based on social learning principles and will utilize an acceptance and commitment therapy approach. Arm 2: Wait list control - these parents will receive the Take a Breath Intervention (Arm 1) approximately 2 months following the completion of Arm 1. Approximately 240 participants were recruited at the hospital wards prior to the screening process which determines eligibility into the parent groups. Arm 2: Wait list control - these parents will receive/be offered the Take a Breath Intervention (Arm 1) following the completion of their Pre and Post questionnaires (where they serve as a comparison group to Arm 1), which is likely to be approximately 2 months after Arm 1.

Sponsors

Murdoch Childrens Research Institute
Lead SponsorOther

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Parents are included if: they are the parent of a child aged zero to 19 years who has a first presentation of a serious childhood illness/injury (cardiac disease requiring surgery within the first month of the child's life, any form of cancer, a stay in paediatric intensive care unit for a minimum of 48 hours, a moderate to severe traumatic brain injury), have an active parenting role, able to comply with study intervention and assessment protocols and are deemed eligible to participate in the efficacy trial of the parent programs based on the study screening procedure.

Exclusion criteria

Parents: Have experienced another major trauma (e.g., death of spouse, partner or loved one in the two month's prior to child's diagnosis), do not have current access to child, have limited spoken English or literacy, and the child is not expected to live longer than six months

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 13, 2026