Clinical Trials Directory

Trials / Completed

CompletedNCT01765166

Parent Treatment for Child Social Adjustment

Continuing the Research and Development of Parent Treatment for Child Social Adjustment

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
240 (actual)
Sponsor
Duke University · Academic / Other
Sex
All
Age
8 Years – 12 Years
Healthy volunteers
Accepted

Summary

This Competing Renewal project continues the research and development of a parent-focused intervention, Parent Guide to SSGRIN, which parallels an established child-focused intervention \[Social Skills GRoup INtervention (S.S. GRIN); for children ages 8-12 years\], in order to teach and reinforce the same social skills and concepts within the home environment. A primary goal is to address questions of relative impact, longer-term treatment benefits, and differential treatment effects of the Parent Guide training on children's social skill development across settings and populations.

Detailed description

This Competing Renewal project continues the research and development of a parent-focused intervention, Parent Guide to SSGRIN, which parallels an established child-focused intervention \[Social Skills GRoup INtervention (S.S. GRIN); for children ages 8-12 years\], in order to teach and reinforce the same social skills and concepts within the home environment. A primary goal of this Competing Renewal is to conduct a rigorous, large-scale, longitudinal research project that is adequately powered to address questions of relative impact, longer-term treatment benefits, and differential treatment effects of the Parent Guide training on children's social skill development across settings and populations. Though schools often struggle with how to increase parent involvement in school-based programs, school officials report that it is infeasible for them to conduct the full series of in-person parent training groups as the Parent Guide's current curriculum demands; therefore, a second goal of this Competing Renewal is to test a Home-study version of the Parent Guide to bridge training into the home environment. The Home-study version of the Parent Guide will be included as a separate treatment condition within the effectiveness trial. This clinical trial will provide S.S.GRIN treatment for 240 children ages 8-12 and vary the level of parent intervention to determine the effectiveness of the two variations of Parent Guide to S.S.GRIN. Parents will be randomly assigned to one of four conditions: (1) Parent Guide treatment; (2) Parent Guide-Home Study treatment; (3) parent attention control; or (4) no treatment. Pre-treatment, post-treatment, 6-month post-treatment, and 12 month post-treatment data will be collected assessing children's social skill development from children, parents, and teachers. Based on past clinical experience, the probability of adverse psychological and behavioral effects from behavioral intervention is very low; however, to ensure participants' safety, a data and safety monitoring plan will be in place.

Conditions

Interventions

TypeNameDescription
BEHAVIORALSSGRIN-Parent GuideAll children will receive traditional SSGRIN(Social Skills Group Intervention), but parents will vary in the level of parent treatment. Families will be randomly assigned to one of four treatment conditions(approximately 25% each): (a) Traditional SSGRIN child treatment with no parent involvement (ChO), (b) SSGRIN child treatment plus parent attention control (PAC), (c) SSGRIN child treatment plus Parent Guide-Home-study treatment (PG-HS), or (d) SSGRIN child treatment plus traditional Parent Guide treatment (PG).

Timeline

Start date
2010-01-01
Primary completion
2011-01-01
Completion
2012-06-01
First posted
2013-01-10
Last updated
2013-01-10

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT01765166. Inclusion in this directory is not an endorsement.