Child Externalizing BehaviorTE-HNCNCT01367847

Technology-Enhanced Helping the Noncompliant Child

A study testing Helping the Noncompliant Child (HNC) and Technology-Enhanced Helping the Noncompliant Child (TE-HNC) in people with Child Externalizing Behavior, run by University of North Carolina, Chapel Hill at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study aimed to examine if technology could enhance the treatment engagement and outcomes of low income parents of 3 to 8 children with externalizing problems. Read more about this study

Who is it for?: Ages 3 to 8 yearsHealthy volunteers can take part
Conditions the study is for: Child Externalizing Behavior
What is being tested?: Helping the Noncompliant Child (HNC) and Technology-Enhanced Helping the Noncompliant Child (TE-HNC)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 22 participants
Where: 1 siteUnited States
Study dates: Sep 2010to May 2013
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 3 to 8 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Lower income
caregiver/parent is legal guardian
3 to 8 year old child
child meets criteria for externalizing disorder or significant externalizing symptoms

Who cannot join

Prior report of child abuse or neglect
current substance abuse/dependence
legal guardian reading level less than 8th grade
child has developmental disability that precludes caregiver utilizing the skills

Trial locations and contacts

1 site in 1 country.

United States1 site

UNC Chapel Hill
Chapel Hill, North Carolina, 27599

Other trials in United States

About this study

Official title: Technology Enhanced Delivery of Treatment for Early Conduct Problems

This study aimed to examine if technology could enhance the treatment engagement and outcomes of low income parents of 3 to 8 children with externalizing problems.

Read the detailed description

The aim of this pilot study is to determine whether a technology-enhanced version of an established behavioral treatment protocol, Helping the Noncompliant Child (HNC; McMahon \& Forehand), enhances the engagement and treatment outcomes of lower income parents of 3 to 8 children with externalizing problems in treatment. It is predicted that families in both the HNC and technology-enhanced HNC (TE-HNC) programs will evidence significant improvement in parenting behavior and child externalizing problems; however, it is predicted that parent-child dyads in the TE-HNC program will require fewer sessions, will be more likely to be retained in the program, will be more likely to remain engaged in the program (e.g., practicing skills between sessions etc.), and will be more likely to have active involvement from their coparenting partners (i.e., other adults and family members who participate in childrearing).In turn, it is expected that the TE-HNC program will boost treatment outcomes.

Conditions: Child Externalizing Behavior
Being tested: Helping the Noncompliant Child (HNC), Technology-Enhanced Helping the Noncompliant Child (TE-HNC)
Keywords: Parenting, Parent-Child Relations, Child Behavior
Medical subject headings: Child Behavior

What participants receive

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

Helping the Noncompliant Child (HNC)Behavioural
Also called HNC
Well-established behavioral parent training program (McMahon \& Forehand) for parents of 3 to 8 y.o. children with externalizing problems
Technology-Enhanced Helping the Noncompliant Child (TE-HNC)Behavioural
Also called TE-HNC
Standard HNC program plus technology-enhancements (see description under Arm)

Study groups in NCT01367847
Study group	Role	What they receive
Helping the Noncompliant Child (HNC)	Active comparator	Standard HNC (see HNC Arm/Title) Program plus Technology-Enhancement (smartphones, which are being used for mid-week video calls to check-in re: skill-building, videotaping of family practice of skills at home, daily surveys re: skills practice \& child behavior, reminders re: practice \& sessions. Receives: Behavioral: Helping the Noncompliant Child (HNC)
Technology-Enhanced HNC (TE-HNC)	Experimental	Standard HNC (see HNC Arm/Title) Program plus Technology-Enhancement (smartphones, which are being used for mid-week video calls to check-in re: skill-building, videotaping of family practice of skills at home, daily surveys re: skills practice \& child behavior, reminders re: practice \& sessions. Receives: Behavioral: Technology-Enhanced Helping the Noncompliant Child (TE-HNC)

What is being measured

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

Retention
Retention assesses whether or not the family completed the full treatment program.
Measured: Baseline to Post-Intervention (average 8 to 12 weeks)
Mean % Sessions Attended as Scheduled
Participation in each weekly session as scheduled was recorded for each family. Mean attendance of scheduled sessions was computed for each parent-child dyad and then for each group. For example, if a parent-child dyad required 8 sessions to master the program skills and attended all 8 sessions as scheduled they would have 100%. If instead, another parent-child dyad also required 8 sessions to complete the program, but half of those were rescheduled at least once. Then the overall average attendance is calculated across the parent-child dyads in each group. Greater scheduled attendance = optimal outcome.
Measured: Baseline to Post-Intervention (average 8 to 12 weeks)

Secondary outcomes (3)

Mean Post-treatment Score Eyberg Child Behavior Inventory (ECBI)
The ECBI is a 36 item measure frequently used in treatment outcome research with young children, as it it reflects problem behavior in this age range and is sensitive to change. Parents rate the frequency of each problem behavior as occurring 0 = never to 7 = always. Scores can range from 0 to 252 with higher scores reflecting greater problem behaviors.
Measured: Baseline to Post-Intervention (average 8 to 12 weeks)
Mean Sessions for Complete Treatment
Mean number of sessions that parent-child dyads in each group required to master the program skills and complete treatment (Fewer sessions to complete treatment considered more cost-effective as parent-child dyads learning skills more efficiently).
Measured: Baseline to Post-Intervention (Average 8 to 12 weeks)
Mean Consumer Satisfaction
Average parent-reported satisfaction with the treatment program on a project-developed consumer satisfaction scale (Possible range = 11 -77; Higher score = greater satisfaction).
Measured: Post-Intervention (Average 8 to 12 weeks)

Timeline

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

Sep 2010May 2013

First posted7 Jun 2011 (estimated)
Study startSep 2010
Primary completionOct 2012
Study completionMay 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (10)Papers the sponsor has linked to this study.
Other trials for Child Externalizing 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.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01367847
Sponsor's protocol ID: 10-0740
Other IDs: 1R34MH082956-01A2
Acronym: TE-HNC
Status last verified: Sep 2019
First submitted: 1 Jun 2011
Last updated: 11 Sep 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Jones DJ, Forehand R, McKee LG, Cuellar J, Kincaid C. Behavioral Parent Training: Is There an "App" for That? Behav Ther (N Y N Y). 2010 Apr;33(4):72-77. No abstract available.
PubMed 22199418
Jones DJ, Forehand R, Cuellar J, Kincaid C, Parent J, Fenton N, Goodrum N. Harnessing innovative technologies to advance children's mental health: behavioral parent training as an example. Clin Psychol Rev. 2013 Mar;33(2):241-52. doi: 10.1016/j.cpr.2012.11.003. Epub 2012 Dec 4.
PubMed 23313761
Forehand R, Jones DJ, Parent J. Behavioral parenting interventions for child disruptive behaviors and anxiety: what's different and what's the same. Clin Psychol Rev. 2013 Feb;33(1):133-45. doi: 10.1016/j.cpr.2012.10.010. Epub 2012 Nov 6.
PubMed 23178234
Jones DJ. Future directions in the design, development, and investigation of technology as a service delivery vehicle. J Clin Child Adolesc Psychol. 2014;43(1):128-42. doi: 10.1080/15374416.2013.859082.
PubMed 24400723
Jones DJ, Forehand R, Cuellar J, Parent J, Honeycutt A, Khavjou O, Gonzalez M, Anton M, Newey GA. Technology-enhanced program for child disruptive behavior disorders: development and pilot randomized control trial. J Clin Child Adolesc Psychol. 2014;43(1):88-101. doi: 10.1080/15374416.2013.822308. Epub 2013 Aug 7.
PubMed 23924046
Loiselle R, Parent J, Georgeson AR, Thissen D, Jones DJ, Forehand R. Validation of the Multidimensional Assessment of Parenting: An application of item response theory. Psychol Assess. 2021 Sep;33(9):803-815. doi: 10.1037/pas0001019. Epub 2021 Apr 26.
PubMed 33900099
Jones DJ, Loiselle R, Zachary C, Georgeson AR, Highlander A, Turner P, Youngstrom JK, Khavjou O, Anton MT, Gonzalez M, Bresland NL, Forehand R. Optimizing Engagement in Behavioral Parent Training: Progress Toward a Technology-Enhanced Treatment Model. Behav Ther. 2021 Mar;52(2):508-521. doi: 10.1016/j.beth.2020.07.001. Epub 2020 Jul 15.
PubMed 33622517
Zachary C, Jones DJ, McKee LG, Baucom DH, Forehand RL. The Role of Emotion Regulation and Socialization in Behavioral Parent Training: A Proof-of-Concept Study. Behav Modif. 2019 Jan;43(1):3-25. doi: 10.1177/0145445517735492. Epub 2017 Oct 13.
PubMed 29029562
Anton MT, Jones DJ, Youngstrom EA. Socioeconomic status, parenting, and externalizing problems in African American single-mother homes: A person-oriented approach. J Fam Psychol. 2015 Jun;29(3):405-415. doi: 10.1037/fam0000086.
PubMed 26053349
Parent J, Jones DJ, Forehand R, Cuellar J, Shoulberg EK. The role of coparents in African American single-mother families: the indirect effect of coparent identity on youth psychosocial adjustment. J Fam Psychol. 2013 Apr;27(2):252-62. doi: 10.1037/a0031477. Epub 2013 Feb 11.
PubMed 23398615

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Child Externalizing Behavior trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Technology Enhanced Delivery of Treatment for Early Conduct Problems
ClinicalTrials.gov ID: NCT01367847
Acronym / sponsor ID: TE-HNC / 10-0740
Conditions: Child Externalizing Behavior
Keywords: Parenting, Parent-Child Relations, Child Behavior
Study type: Interventional
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: University of North Carolina, Chapel HillUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH)
Study start: Sep 2010
Primary completion: Oct 2012 (actual)
Study completion: May 2013 (actual)
First posted: 7 Jun 2011 (estimated)
Results: Posted 14 Sep 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study aimed to examine if technology could enhance the treatment engagement and outcomes of low income parents of 3 to 8 children with externalizing problems.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Helping the Noncompliant Child (HNC)	Active comparator	Behavioral: Helping the Noncompliant Child (HNC)Standard HNC (see HNC Arm/Title) Program plus Technology-Enhancement (smartphones, which are being used for mid-week video calls to check-in re: skill-building, videotaping of family practice of skills at home, daily surveys re: skills practice \& child behavior, reminders re: practice \& sessions.
Technology-Enhanced HNC (TE-HNC)	Experimental	Behavioral: Technology-Enhanced Helping the Noncompliant Child (TE-HNC)Standard HNC (see HNC Arm/Title) Program plus Technology-Enhancement (smartphones, which are being used for mid-week video calls to check-in re: skill-building, videotaping of family practice of skills at home, daily surveys re: skills practice \& child behavior, reminders re: practice \& sessions.

Who may qualify

Ages: 3 to 8 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (4 listed)

Lower income
caregiver/parent is legal guardian
3 to 8 year old child
child meets criteria for externalizing disorder or significant externalizing symptoms

Key exclusion criteria (4 listed)

Prior report of child abuse or neglect
current substance abuse/dependence
legal guardian reading level less than 8th grade
child has developmental disability that precludes caregiver utilizing the skills

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Helping the Noncompliant Child (HNC)Also: HNCWell-established behavioral parent training program (McMahon \& Forehand) for parents of 3 to 8 y.o. children with externalizing problems	Behavioural	Helping the Noncompliant Child (HNC)
Technology-Enhanced Helping the Noncompliant Child (TE-HNC)Also: TE-HNCStandard HNC program plus technology-enhancements (see description under Arm)	Behavioural	Technology-Enhanced HNC (TE-HNC)

Primary outcome

Retention
Time frame: Baseline to Post-Intervention (average 8 to 12 weeks)
Retention assesses whether or not the family completed the full treatment program.
Mean % Sessions Attended as Scheduled
Time frame: Baseline to Post-Intervention (average 8 to 12 weeks)
Participation in each weekly session as scheduled was recorded for each family. Mean attendance of scheduled sessions was computed for each parent-child dyad and then for each group. For example, if a parent-child dyad required 8 sessions to master the program skills and attended all 8 sessions as scheduled they would have 100%. If instead, another parent-child dyad also required 8 sessions to complete the program, but half of those were rescheduled at least once. Then the overall average attendance is calculated across the parent-child dyads in each group. Greater scheduled attendance = optimal outcome.

3 secondary outcomes

Mean Post-treatment Score Eyberg Child Behavior Inventory (ECBI)
Time frame: Baseline to Post-Intervention (average 8 to 12 weeks)
Mean Sessions for Complete Treatment
Time frame: Baseline to Post-Intervention (Average 8 to 12 weeks)
Mean Consumer Satisfaction
Time frame: Post-Intervention (Average 8 to 12 weeks)

Results and safety

Results posted to the registry on 14 Sep 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Helping the Noncompliant Child	10	8
TE-HNC	9	7

Primary outcome: Retention

Time frame: Baseline to Post-Intervention (average 8 to 12 weeks). Count of participants. Unit: Participants

Measure	Helping the Noncompliant Child n = 10	TE-HNC n = 9
Value	8	7

Population analysed: Given that these analyses focus on retention, the analysis sample is the 19 enrolled parent-child dyads (i.e., including the drop-outs)

Primary outcome: Mean % Sessions Attended as Scheduled

Time frame: Baseline to Post-Intervention (average 8 to 12 weeks). Mean (Standard Deviation). Unit: percentage of scheduled sessions

Measure	Helping the Noncompliant Child n = 8	TE-HNC n = 7
Value	90 (11)	97 (5)

Population analysed: Given the pilot nature of study and smalll sample size, intent to treat analyses were not conducted. Rather, analyses were conducted on those parent-child dyads who completed all sessions within each group.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 3 years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Helping the Noncompliant Child	0 of 10 (0%)	0 of 10 (0%)	0 of 10
TE-HNC	0 of 9 (0%)	0 of 9 (0%)	0 of 9

Limitations and caveats (from the sponsor): This is a preliminary randomized control trial with a small sample size and limited statistical power and, thus, findings should be interpreted with caution.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 22199418Jones DJ, Forehand R, McKee LG, Cuellar J, Kincaid C. Behavioral Parent Training: Is There an "App" for That? Behav Ther (N Y N Y). 2010 Apr;33(4):72-77. No abstract available.
Background: PubMed 23313761Jones DJ, Forehand R, Cuellar J, Kincaid C, Parent J, Fenton N, Goodrum N. Harnessing innovative technologies to advance children's mental health: behavioral parent training as an example. Clin Psychol Rev. 2013 Mar;33(2):241-52. doi: 10.1016/j.cpr.2012.11.003. Epub 2012 Dec 4.
Background: PubMed 23178234Forehand R, Jones DJ, Parent J. Behavioral parenting interventions for child disruptive behaviors and anxiety: what's different and what's the same. Clin Psychol Rev. 2013 Feb;33(1):133-45. doi: 10.1016/j.cpr.2012.10.010. Epub 2012 Nov 6.
Background: PubMed 24400723Jones DJ. Future directions in the design, development, and investigation of technology as a service delivery vehicle. J Clin Child Adolesc Psychol. 2014;43(1):128-42. doi: 10.1080/15374416.2013.859082.
Results publication: PubMed 23924046Jones DJ, Forehand R, Cuellar J, Parent J, Honeycutt A, Khavjou O, Gonzalez M, Anton M, Newey GA. Technology-enhanced program for child disruptive behavior disorders: development and pilot randomized control trial. J Clin Child Adolesc Psychol. 2014;43(1):88-101. doi: 10.1080/15374416.2013.822308. Epub 2013 Aug 7.
Derived from this study: PubMed 33900099Loiselle R, Parent J, Georgeson AR, Thissen D, Jones DJ, Forehand R. Validation of the Multidimensional Assessment of Parenting: An application of item response theory. Psychol Assess. 2021 Sep;33(9):803-815. doi: 10.1037/pas0001019. Epub 2021 Apr 26.
Derived from this study: PubMed 33622517Jones DJ, Loiselle R, Zachary C, Georgeson AR, Highlander A, Turner P, Youngstrom JK, Khavjou O, Anton MT, Gonzalez M, Bresland NL, Forehand R. Optimizing Engagement in Behavioral Parent Training: Progress Toward a Technology-Enhanced Treatment Model. Behav Ther. 2021 Mar;52(2):508-521. doi: 10.1016/j.beth.2020.07.001. Epub 2020 Jul 15.
Derived from this study: PubMed 29029562Zachary C, Jones DJ, McKee LG, Baucom DH, Forehand RL. The Role of Emotion Regulation and Socialization in Behavioral Parent Training: A Proof-of-Concept Study. Behav Modif. 2019 Jan;43(1):3-25. doi: 10.1177/0145445517735492. Epub 2017 Oct 13.
Derived from this study: PubMed 26053349Anton MT, Jones DJ, Youngstrom EA. Socioeconomic status, parenting, and externalizing problems in African American single-mother homes: A person-oriented approach. J Fam Psychol. 2015 Jun;29(3):405-415. doi: 10.1037/fam0000086.
Derived from this study: PubMed 23398615Parent J, Jones DJ, Forehand R, Cuellar J, Shoulberg EK. The role of coparents in African American single-mother families: the indirect effect of coparent identity on youth psychosocial adjustment. J Fam Psychol. 2013 Apr;27(2):252-62. doi: 10.1037/a0031477. Epub 2013 Feb 11.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Deborah J Jones, PhD principal investigator

UNC Chapel Hill

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Retention (time frame: Baseline to Post-Intervention (average 8 to 12 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01367847, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2019.