Feasibility and Acceptability of a Digital Intervention to Support Shared Decision-making in Children's and Young People's Mental Health: Mixed Methods Pilot Randomized Controlled Trial.

BACKGROUND

Interventions to involve parents in decisions regarding children's and young people's mental health are associated with positive outcomes. However, appropriately planning effectiveness studies is critical to ensure that meaningful evidence is collected. It is important to conduct pilot studies to evaluate the feasibility and acceptability of the intervention itself and the feasibility of the protocol to test effectiveness.

OBJECTIVE

This paper reports the findings from a feasibility and acceptability study of Power Up for Parents, an intervention to promote shared decision-making (SDM) and support parents and caregivers making decisions regarding children's and young people's mental health.

METHODS

A mixed method study design was adopted. In stage 1, health care professionals and parents provided feedback on acceptability, usefulness, and suggestions for further development. Stage 2 was a multicenter, 3-arm, individual, and cluster randomized controlled pilot feasibility trial with parents accessing services related to children's and young people's mental health. Outcome measures collected data on demographics, participation rates, SDM, satisfaction, and parents' anxiety. Qualitative data were analyzed using thematic analysis. Google Analytics estimates were used to report engagement with the prototype. Outcomes from both stages were tested against a published set of criteria for proceeding to a randomized controlled trial.

RESULTS

Despite evidence suggesting the acceptability of Power Up for Parents, the findings suggest that recruitment modifications are needed to enhance the feasibility of collecting follow-up data before scaling up to a fully powered randomized controlled trial. On the basis of the Go or No-Go criteria, only 50% (6/12) of the sites successfully recruited participants, and only 38% (16/42) of parents completed follow-up measures. Nonetheless, health care practitioners and parents generally accessed and used the intervention. Themes describing appearance and functionality, perceived need and general helpfulness, accessibility and appropriateness, and a wish list for improvement emerged, providing valuable information to inform future development and refinement of the intervention.

CONCLUSIONS

Owing to the high attrition observed in the trial, proceeding directly to a full randomized controlled trial may not be feasible with this recruitment strategy. Nonetheless, with some minor adjustments and upgrades to the intervention, this pilot study provides a platform for future evaluations of Power Up for Parents.

TRIAL REGISTRATION

International Standard Randomized Controlled Trial Number (ISRCTN) 39238984; http://www.isrctn.com/ISRCTN39238984.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/14571.