Parenting Acceptance and Commitment Therapy Online (PACT Online) for parents of children diagnosed with or with increased likelihood of neurodevelopmental disability: study protocol of a randomised controlled trial

Introduction
Approximately 1 in 13 Australian children have a neurodevelopmental disability. This project aims to assess the effectiveness and implementation of an online parenting support programme, Parenting Acceptance and Commitment Therapy (PACT) Online, for parents of children with neurodevelopmental disabilities for improving the parent–child relationship and parent and child outcomes.

Methods and analysis
This hybrid type 1 randomised controlled trial will focus on evaluating intervention effectiveness and understanding the context for implementation. The primary outcome is observed emotional availability within parent–child interactions assessed at postintervention (12 weeks postbaseline) with additional measurement at follow-up (6 months postbaseline). Secondary outcomes include (1) parent-reported emotional availability, (2) parental mindfulness, (3) parent mental health, (4) psychological flexibility, (5) adjustment to child’s disability, (6) health behaviour and (7) regulatory abilities as well as child outcomes of (1) mental health, (2) adaptive behaviour and (3) regulatory abilities. Evaluation of implementation will include an economic evaluation of costs and consequences, and an implementation analysis grounded in the consolidated framework for implementation research with a focus on contextual factors influencing implementation.

Ethics and dissemination
Ethical approval has been obtained from the University of Queensland Human Research Ethics Committee (023/HE000040). Dissemination of study outcomes will occur through the appropriate scientific channels. Long-term implementation will be grounded within the implementation analysis and occur in partnership with the partner organisations and consumer engagement panel. This will include releasing the PACT Online intervention as a massive open online course on the edX platform if support for intervention effectiveness and implementation is found.

Trial registration number
ACTRN12623000612617; this trial has been registered with the Australian New Zealand Clinical Trials Registry.

Leggi
Giugno 2025

Skills for adolescent WELLbeing (SWELL): protocol for a preventive effectiveness randomised controlled trial for young people at high-familial risk of depression with treatment optimisation for parents with depression at study entry comparing online group cognitive behavioural therapy (CBT) with treatment as usual

Introduction
Young people (YP) whose parents have depression are at elevated risk for developing depression themselves and could benefit from preventive interventions. However, when parents are in a depressive episode, this reduces the effects of psychological interventions for depression in YP. Moreover, parental depression is often managed suboptimally in usual care. There is, therefore, a case for identifying and optimising parental depression treatment to enhance the effectiveness of psychological preventive interventions for depression in YP.

Methods and analysis
This is a randomised controlled trial (Skills for adolescent WELLbeing) to determine the effectiveness of a cognitive behavioural therapy (CBT) intervention compared with usual care in increasing the time to a major depressive episode in YP by 9-month follow-up (primary outcome). The intervention offers a 12-week treatment-optimisation phase for parents depressed at study entry, followed by randomisation of the young person to a small group manualised online CBT programme facilitated by a therapist. YP allocated to the intervention will receive eight weekly sessions plus three monthly continuation sessions. Secondary outcomes include the number of depression-free weeks, mental health symptoms and functioning. Mechanisms of intervention action will be assessed with mediation analysis of quantitative data and thematic analysis of qualitative interviews. Participants (parents/carers with depression and their children aged 13–19 years) will be identified through existing cohorts of adults with depression, from primary care through health boards in Wales and England, UK, schools and advertising including via social media.

Ethics and dissemination
The trial has received ethical approval from Wales NHS Research Ethics Committee (REC) 5, the Health Research Authority and Health and Care Research Wales (IRAS 305331; REC 22/WA/0254). This manuscript is based on V.5.7 of the protocol (17 January 2025). Findings will be disseminated in peer-reviewed journals and conferences. Reports and social media messages will be used to disseminate findings to the wider public.

Trial registration number
ISRCTN13924193 (date registered: 15 March 2023).

Leggi
Giugno 2025

Campaign messages to support pictorial health warning labels for little cigars and cigarillos: an online survey-based experiment

Objectives
Campaigns to support pictorial health warning labels (HWLs) for cigarettes have enhanced their effectiveness, but little to no research on campaign messages to support little cigars and cigarillos (LCC) pictorial HWLs exists. The goal of this study was to examine the effectiveness of messages to augment pictorial HWLs on LCCs among priority populations.

Design
Online survey-based experiment.

Setting
Qualtrics research panel online of US adults, recruited between January and February 2023.

Participants
Adults ages 21–29 who reported current cigar use and reside in the USA.

Interventions
Participants (n=315) were randomly assigned to one of three conditions: (1) messages designed to elaborate pictorial HWLs, (2) pictorial HWLs alone and (3) messages and pictorial HWLs paired together.

Procedures and outcome measures
Within conditions, participants were shown six negative health effects of LCCs and answered questions about perceived message effectiveness (PME), negative affect, thinking about risks (TAR) and self-reported learning (SRL) as well as questions on quit intention, concern about their health and reactance. Using mixed-effects models and ANOVA, we evaluated for differences across conditions.

Results
Most participants identified as male (60%) and either Black (45%) or White (45%). PME was very high across all three conditions (≥ 3.85) but no difference between conditions in a statistically significant manner (p=0.18). Mixed-effects models indicated that negative affect varied across conditions, highest in condition 2 (3.76; 95% CI 3.58, 3.94) and lowest in condition 3 (3.44; 95% CI 3.27, 3.61) (p=0.01), and showed no statistically significant difference between conditions for SRL (p=0.31) or TAR (p=0.43). No statistically significant difference was noted for quit intentions (p=0.16), health concern (p=0.28) or reactance (p=0.84).

Conclusions
Pictorial HWLs, campaign messages and the combination of the conditions were all perceived as very effective, with little differences in PME. Such findings indicate that pictorial HWLs on LCCs and communication messages about LCCs both appear as promising approaches to reducing LCC use among target populations. Longitudinal studies with ongoing exposure may identify factors that can enhance the effectiveness of campaign messages to enhance pictorial HWLs for LCCs.

Leggi
Giugno 2025