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

Boston Medical Center (BMC)

Status: Withdrawn

Conditions: Children With Special Health Care Needs (CSHCN); Child Maltreatment

Treatments: Behavioral: Intervention; Other: Control

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02742831

1K23HD078503-01A1 (U.S. NIH Grant/Contract)

H-35105

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Intervention

Experimental group

Description:

The intervention group will receive a one-on-one in-person intervention of 6 sessions, each lasting approximately 60 minutes. The intervention is intended to be delivered over a period of 12 weeks, with sessions occurring every 1-2 weeks. The overview of the 6 sessions is as follows: 1. Behavioral chain analysis of episodes where parent felt stressed and episode where things went well. Identification of sources of interpersonal support. 2. Stress relief. Development of a detailed crisis plan. 3. Problem solving techniques. 4. Emotional regulation exercises. 5. Positive parenting, review of parenting challenges. 6. Reflection, repeat behavioral chain analysis. Update crisis plan.

Treatment:

Behavioral: Intervention

Control

Active Comparator group

Description:

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.

Treatment:

Other: Control