Improving Self-Regulation Among Adopted Children

NCT04061031 | Withdrawn

• 1 other identifier: 12662
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed study will examine two different intervention programs and whether they improve self-regulation of adopted children. The study is a small randomized controlled trial to test the feasibility of conducting a larger, R01-funded clinical trial. Outcomes will primarily be focused on feasibility concerns, such as recruitment and retention of a sufficient number of participants and implementation of treatment protocols with fidelity, as well as determining initial effect size estimates that might inform later power analyses and examining the functioning of developmental assessment measures when administered in the context of a clinical trial.

Conditions

Self-regulation

Keywords

Self-regulation, adoption, parent-child realtionship

Outcome Measures

Primary Outcomes (1)

• Strengths and Difficulties Questionnaire (SDQ)

  A measure of broadband concerns with emotional, behavioral, cognitive, and social regulation

  6 months

Study Arms (2)

Parent-Child Interaction Therapy

EXPERIMENTAL

Behavioral: Parent-Child Interaction Therapy (PCIT)

Child-Centered Therapy with Parent Education

ACTIVE COMPARATOR

Behavioral: Child-Centered Therapy with Parent Education

Interventions

Parent-Child Interaction Therapy (PCIT) BEHAVIORAL

A trained clinician teaches the caregiver to deliver a number of behavior modification techniques for use with the child and coaches the caregiver in the delivery of those techniques.

Parent-Child Interaction Therapy

Child-Centered Therapy with Parent Education BEHAVIORAL

A trained clinician delivers non-directive, child-centered treatment techniques with the child while providing education to the parent based on current recommendations from the Department of Health and Human Services' Child Welfare Information Gateway.

Also known as: Treatment-as-Usual

Child-Centered Therapy with Parent Education

Eligibility Criteria

• Age: 4 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Child is living with an adoptive caregiver
• Caregiver reports a qualifying score for the child on the SDQ
• Fluent in English
• Child is rated by the caregiver with a score of 14 or greater on the full scale of the SDQ.

You may not qualify if:

• Child diagnosed with a severe developmental delay and/or psychiatric problem that necessitates a higher level of care.
• IQ below 70 as assessed at the time of the first assessment.

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Self-Control

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Psychiatry

Study Record Dates

• First Submitted: August 16, 2019
• First Posted: August 19, 2019
• Study Start: October 14, 2019
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: December 16, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)