Natural Helpers and PCIT

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 2 to 12 years
• All sexes
• No healthy volunteers
• Child

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

About this study

Official title: The Development and Implementation of a Natural Helpers Program to Increase the Recruitment, Retention, and Engagement of Underserved Families in Parent-Child Interaction Therapy (PCIT)

Conditions

Child Behavior, Parenting

Being tested

Standard Parent-Child Interaction Therapy (PCIT), Natural Helpers (NH)

Keywords

Community Health Workers, Mental Health Disparities

Medical subject headings

Child Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Standard Parent-Child Interaction Therapy (PCIT)Behavioural

  PCIT is an evidence-based behavioral parenting intervention. It is administered as weekly, one-hour sessions with a bilingual PCIT therapist for 18 weeks in one of three PCIT clinics embedded within neighborhood community agencies or virtually.

• Natural Helpers (NH)Behavioural

  Natural helpers are lay people to whom others naturally turn for advice, emotional support, and tangible aid. Families received weekly sessions with a natural helpers in their home or virtually for 30-45 minutes for a maximum of 18 weeks. During sessions, natural helpers work with families to (1) explain parenting principles in a culturally and responsive manner; (2) support them in their skill acquisition; and (3) troubleshoot structural barriers to service and other basic life needs.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Child externalizing behavior as measured by ECBI Intensity Scale

   The Eyberg Child Behavior Inventory (ECBI) is a 36-item caregiver report measure of disruptive behaviors in children ages 2-16 . The Intensity Scale assesses the frequency of behavior problems (1=never to 7=always) with total scores ranging from 36 to 252. A raw score of 131 or higher on the Intensity Scale is considered clinically significant child externalizing behavior.

   Measured: Up to 26 weeks

2. Child externalizing behavior as measured by ECBI Problem Scale

   The Eyberg Child Behavior Inventory (ECBI) is a 36-item caregiver report measure of disruptive behaviors in children ages 2-16 . The Problem Scale assesses caregiver perceived behavior problems (1 = yes, 0 = no) with total scores ranging from 0 to 36. A raw score of 15 or higher on the Problem Scale is considered clinically significant child externalizing behavior.

   Measured: Up to 26 weeks

3. Parenting Skills as measured by the Dyadic Parent-Child Interaction Coding System (DPICS-IV)

   The DPICS-IV is a behavioral observation tool used to code and assess caregiver behaviors and the quality of caregiver and child interactions. PCIT therapists code the three 5-minute DPICS-IV observations: (1) child-led play (CLP), (2) parent-led play (PLP), and (3) clean-up (CU). The number of positive parenting practices (e.g., labeled praises, reflections, and behavior descriptions) and negative parenting practices are tallied (e.g., questions, commands, and criticisms) are coded during CLP observations. During PLP and CU observations, caregiver verbalizations were coded to generate rates of: (1) caregiver effective commands, (2) caregiver correct follow-through on effective commands, and (3) child compliance to effective commands. The higher the score the higher the parenting behavior and child compliance.

   Measured: Up to 26 weeks

4. Parenting Stress as measured by Parenting Stress Index Short Form (PSI-SF-4)

   The PSI-SF-4 is a 36-item self-report questionnaire used to measure caregiver stress and difficulties in the caregiver-child relationship for caregivers of youth between ages 0-12. The PSI-SF-4 yields a Total Stress percentile score (0-100) with higher scores indicating higher stress.

   Measured: Up to 26 weeks

5. Family conflict as measured by Bloom's Family Processes Scale

   The Bloom's Family Processes Scale assesses family conflict and cohesion using a 5-item conflict subscale (e.g. "we fight a lot in our family"). Caregivers rate their level of agreement on a five-point Likert scale (1=strongly agree to 5=strongly disagree). Total score ranges from 5-25 with the higher scores indicating greater conflict.

   Measured: Up to 26 weeks

6. Family cohesion as measured by Bloom's Family Processes Scale

   The Bloom's Family Processes Scale assesses family cohesion using a 5-item cohesion subscale (e.g., "there is a feeling of togetherness in our family"). Caregivers rate their level of agreement on a five-point Likert scale (1=strongly agree to 5=strongly disagree). Total score ranges from 5-25 with the higher scores indicating greater cohesion.

   Measured: Up to 26 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted1 Jun 2022
2. Study start3 Dec 2018
3. Primary completion27 Dec 2026 (estimated)
4. Study completion27 Dec 2026 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Child BehaviorStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.