A Theory-Based Intervention to Prevent Child Neglect in High-Risk
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Child Maltreatment
- Sponsor
- Boston Medical Center
- Locations
- 1
- Primary Endpoint
- Study Logistics - subject enrollment
- Status
- Withdrawn
- Last Updated
- 7 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Caroline Kistin
BMC Attending Physician
Boston Medical Center
Eligibility Criteria
Inclusion Criteria
- •Primary caregiver of a child under age 7 with a special health care need, defined as a chronic physical, emotional, or behavioral health condition
- •Child has been referred to the Child Protection Team for neglect that was ultimately not substantiated
- •Fluent in English or Spanish
Exclusion Criteria
- •Prior history of substantiated child maltreatment
Outcomes
Primary Outcomes
Study Logistics - subject enrollment
Time Frame: Monthly change from baseline to 12 months post randomization
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.
Study Logistics - fidelity of intervention delivery
Time Frame: 3 months post randomization
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.
Secondary Outcomes
- Re-referral to child protection team or social services(12 months post randomization)
- Adherence to recommended medical care(12 months post randomization)