NCT02742831

A Pilot Intervention With Families of Children With Special Health Care Needs

A Theory-Based Intervention to Prevent Child Neglect in High-Risk

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Boston Medical Center · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Child Maltreatment
• Children With Special Health Care Needs (CSHCN)

Interventions

Type	Name	Description
BEHAVIORAL	Intervention	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.
OTHER	Control	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.

Timeline

• Start date: 2017-08-01
• Primary completion: 2018-08-01
• Completion: 2018-08-01
• First posted: 2016-04-19
• Last updated: 2018-08-14

Locations

1 site across 1 country: United States