Clinical trial NCT02742831: A Pilot Intervention With Families of Children With Special Health Care Needs
Official title: A Theory-Based Intervention to Prevent Child Neglect in High-Risk
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Child Maltreatment
Children With Special Health Care Needs (CSHCN)
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2016-04-19
Enrollment: 0
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Study Logistics - subject enrollment
timeFrame: Monthly change from baseline to 12 months post randomization
measure: Study Logistics - fidelity of intervention delivery
timeFrame: 3 months post randomization
Secondary outcomes:
measure: Re-referral to child protection team or social services
timeFrame: 3 months post randomization
measure: Re-referral to child protection team or social services
timeFrame: 6 months post randomization
measure: Re-referral to child protection team or social services
timeFrame: 12 months post randomization
measure: Adherence to recommended medical care
timeFrame: 3 months post randomization
measure: Adherence to recommended medical care
timeFrame: 6 months post randomization
measure: Adherence to recommended medical care
timeFrame: 12 months post randomization
Other outcomes:
measure: Parental well-being and mental health - Quick Inventory of Depressive Symptomatology
timeFrame: Change in score from baseline to 12 months post randomization
measure: Parental well-being and mental health - the Social Adjustment Scale-Short Report
timeFrame: Change in score from baseline to 12 months post randomization
measure: Parental well-being and mental health - the Medical Outcomes Survey Social Support
timeFrame: Change in score from baseline to 12 months post randomization
measure: Parental well-being and mental health - the Perceived Stress Scale
timeFrame: Change in score from baseline to 12 months post randomization
measure: Parental well-being and mental health - the Parenting Stress-Short Form
timeFrame: Change in score from baseline to 12 months post randomization
measure: Parental well-being and mental health - the Parenting Scale
timeFrame: Change in score from baseline to 12 months post randomization
measure: Parental well-being and mental health - the Parent Development Interview-Revised
timeFrame: Change in score from baseline to 12 months post randomization
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston University School of Medicine/Boston Medical Center
name: Caroline J Kistin, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: