This is a pilot randomized controlled trial of a behavioral intervention focused on improving parenting skills and preventing child neglect in families of children with special health care needs. The intervention focuses on problem solving, distress tolerance, and emotional regulation skills.
This pilot randomized controlled trial will be conducted with 60 caregivers of children with special health care needs who have been reported to the child protection team at Boston Medical Center with concern for neglect that was ultimately not substantiated. Half of the subjects will be randomly assigned to receive the 6-session, one-on-one, in-person, behavioral intervention focused on problem solving, emotional regulation, and distress tolerance. The other half will be randomly assigned to the control group and will receive periodic check-ins and referrals to community resources as needed. Both groups will be followed for 12 months after randomization. Children who have previously experienced neglect, or other forms of maltreatment, will not included in the study. Children will be defined as having special health care needs if they have a chronic physical, emotional, or behavioral condition. With this pilot, the investigators aim to field-test study mechanics, including enrollment, randomization, and the collection of baseline and follow-up data; and obtain empiric estimates of study parameters to inform a subsequent fully-powered randomized controlled trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
The intervention group will receive a 6-session intervention. The overview of the 6 sessions is as follows: 1. "Behavioral chain analysis" of episode where parent felt stressed with child and episode where things went well. Identification of sources of interpersonal support. 2. Stress relief techniques. Identification of short and long-term goals. Development of a detailed crisis plan. 3. Problem solving techniques. 4. Emotional regulation. Exercises to identify moods and explore connections between feelings, thoughts, and behavior. 5. Positive parenting, review of common and specific parenting challenges, child development, short and long-term effects of different discipline approaches. 6. Reflection, repeat behavioral chain analysis. Update crisis plan.
The families in the control group will be contacted by a member of the study team 6 times in 12 weeks to approximate the frequency of contact that the intervention group receives. The study team member will check in with families on the telephone or in person and will help them connect with clinic and community resources as needed.
Boston Medical Center
Boston, Massachusetts, United States
Study Logistics - subject enrollment
As this is a pilot study, the primary objective is to field test study logistics, including subject enrollment. The investigators will review monthly counts of enrolled subjects from baseline to 12 months post-randomization, and will compare the number of subjects in each study arm to target enrollment goals. Because of emerging consensus that group-to-group comparisons in a pilot study are not only invalid but also misleading, estimating effect size is deliberately not our primary study objective.
Time frame: Monthly change from baseline to 12 months post randomization
Study Logistics - fidelity of intervention delivery
For the intervention group, treatment fidelity will be assessed by audio taping a random 10% of sessions and scoring them with standardized instruments. The investigators will measure the proportion of sessions delivered with fidelity. Because of emerging consensus that group-to-group comparisons in a pilot study are not only invalid but also misleading, estimating effect size is deliberately not our primary study objective.
Time frame: 3 months post randomization
Re-referral to child protection team or social services
The investigators will obtain empirical estimates of the proportion of control group subjects to be re-referred to child protection team or social services by 3 months post randomization. This will allow the investigators to power a later study for this dichotomous outcome.
Time frame: 3 months post randomization
Re-referral to child protection team or social services
The investigators will obtain empirical estimates of the proportion of control group subjects to be re-referred to child protection team or social services by 6 months post randomization. This will allow the investigators to power a later study for this dichotomous outcome.
Time frame: 6 months post randomization
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Re-referral to child protection team or social services
The investigators will obtain empirical estimates of the proportion of control group subjects to be re-referred to child protection team or social services by 12 months post randomization. This will allow the investigators to power a later study for this dichotomous outcome.
Time frame: 12 months post randomization
Adherence to recommended medical care
The investigators will conduct chart review to count the number of missed medical appointments, emergency department visits, and hospitalizations in the 90 days preceding the analysis. The investigators will specifically examine the proportion of control group subjects to experience each outcome and will use this data to power a later study.
Time frame: 3 months post randomization
Adherence to recommended medical care
The investigators will conduct chart review to count the number of missed medical appointments, emergency department visits, and hospitalizations in the 90 days preceding the analysis. The investigators will specifically examine the proportion of control group subjects to experience each outcome and will use this data to power a later study.
Time frame: 6 months post randomization
Adherence to recommended medical care
The investigators will conduct chart review to count the number of missed medical appointments, emergency department visits, and hospitalizations in the 90 days preceding the analysis. The investigators will specifically examine the proportion of control group subjects to experience each outcome and will use this data to power a later study.
Time frame: 12 months post randomization