The goal of this study is to advance the science of a brief parent mental health
intervention for parents of children with pediatric feeding disorder using Parent
Acceptance and Commitment Therapy (PACT-F). The ultimate goal of this research is to
improve parent mental health and child health and feeding outcomes through a
parent-focused behavioral intervention.
PACT-F is a 2-session acceptance and commitment therapy (ACT) intervention guided by
Brown and Whittingham's ACT intervention for parents of children with neurodevelopmental
conditions. Intervention content is based on principles of ACT, an evidence-based
treatment for adult mental health problems. The intervention content is therefore broadly
applicable to all parents but was specifically tailored for the needs of parents of
children with neurodevelopmental conditions. In study phase 1 of this award, the
investigators adapted parent ACT for parents of children with pediatric feeding disorder
(PACT-F) with consultation from 2 parents of children with pediatric feeding disorder and
2 experts in parent ACT. The investigators now have a complete treatment package that has
been tailored for parents of children with pediatric feeding disorder and is ready to be
piloted.
Thus, in this study the investigators will conduct a feasibility and proof-of-concept
pilot of a 2-session parent-focused ACT intervention tailored to meet the needs of
parents of children with pediatric feeding disorder (PACT-F). The goal of this pilot is
to determine factors that impact the success of recruitment, retention, assessment, and
treatment delivery for the PACT-F clinical trial and to test the intervention's proof of
concept (i.e., does it show a clinically meaningful signal of change in parent mental
health). This study will be conducted at a single site (Children's Mercy Hospital). The
investigators will pilot the clinical trial procedures and monitor feasibility success,
and factors that may impact feasibility success. Participants who meet inclusion criteria
will be randomized to either PACT-F or an attention control (control) condition.
Participants will be blind to treatment condition (single blind study). The aim of the
feasibility analyses is to evaluate factors critical to success, rather than evaluating
whether the intervention is "feasible or not feasible". The aim of the proof-of-concept
analyses is to determine if this intervention has promise and warrants a larger efficacy
trial.
Parents randomized to PACT-F will complete two 90-minute PACT-F sessions individually
with a study interventionist, 2 weeks apart. Parents randomized to the control group will
complete two 90-minute sessions individually with a study interventionist, 2-weeks apart
(focused on nutrition education). The control intervention will be parallel to the ACT
intervention in all ways, including interactive components and the face-to-face time with
health professionals (interventionists). The control condition intervention has already
been developed by Dr. Davis's research team and covers a range of nutrition and healthy
lifestyle topics including the United States Department of Agriculture's (USDA) MyPlate.
An attention control condition was selected to mimic the interpersonal benefits that may
come from meeting individually with a caring professional. The control condition
intervention content (healthy lifestyles) was specifically chosen as it most closely
reflects the types of information that parents would learn from healthcare professionals
about the type of nutrition that their child needs. However, this type of intervention
should not impact parent mental health.
Interventionists for both conditions will be individuals with at least master's degree
training in mental health or a related field. The interventions will take via tele-video
conferencing to allow participants to participate from home without needing
transportation to and from the hospital. Both arms of the intervention will be manualized
and interventionists in both arms will be trained using didactics and role playing with
the Principle Investigator(PI). Intervention fidelity will be monitored by audio/video
recording all sessions. The PI (Dr. Bakula) will review recordings each week and conduct
separate 1-hour weekly supervision of study interventionists for each arm of the study
(PACT-F & control).
Strategies will be used to promote fidelity in line with recommendations from the NIH
Behavior Change Consortium. A fidelity checklist will be developed in line with
adaptations to the intervention and will be piloted with study interventionists. The
fidelity checklist will be refined during research team meetings. The fidelity checklist
will be reviewed by the PI during supervision.
Hypothesis testing: The investigators will test the hypothesis that PACT-F results in
clinically meaningful change using the Reliable Change Index (RCI; success defined as RCI
> 1.96). The investigators anticipate that these procedures will be feasible, with
feasibility success defined as recruitment rate above 60%, and retention, assessment
completion, and intervention completion rate above 80%. Mixed methods data collection
will identify factors that impact 1) recruitment rate (qualitative interviews, % meeting
inclusion criteria, # of contact attempts), 2) retention rates (qualitative interviews,
baseline characteristics; treatment group), 3) assessment completion rate (qualitative
interviews, measure type), and 4) treatment completion rate (qualitative interviews,
scheduling, treatment location).
The proposed study is an important first step towards developing an evidence-based
treatment that can be used with parents of children with pediatric feeding disorder. This
intervention has the potential to improve parent mental health, as well as child health,
and therefore has the potential to have broad public health impact.