Clinical trial NCT01765166: Parent Treatment for Child Social Adjustment
Official title: Continuing the Research and Development of Parent Treatment for Child Social Adjustment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Interpersonal Relations
Keywords: Social Skill Training
Social Interaction
Peer relations
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2013-01-10
Enrollment: 240
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:children ages 8-12 experiencing peer difficulties who are English speaking. To confirm eligibility regarding peer difficulties, 3-C staff will conduct a brief (5 minute) phone-survey with parents for two sub-scales of the Social Skills Rating System: Parent Form (SSRS; Gresham \& Elliott, 1990). To be eligible for participation, a child must have a standard score either (a) less than one standard deviation (std) on the Social Skills Scale (\<84%ile) or (b) greater than one std on the Problem Behavior Scale (\>84%ile).

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Exclusion Criteria:SSGRIN group therapy is not recommended for extremely aggressive children (DeRosier, 2005), so any child scoring higher than two std on the Externalizing Problem Behavior Scale (\>97%ile) will be excluded from participation and referral sources to other appropriate community resources will be given to parents.

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Primary outcomes:
measure: Children's social skills
timeFrame: pre-treatment, post-treatment, 6 months post-treatment, 12 months post-treatment
Secondary outcomes:
measure: Parental, child, and dyadic behavioral observations
timeFrame: pre-treatment, post-treatment, 6 months post-treatment, 12 months post-treatment
Other outcomes:
Locations:
city: Cary
country: United States
facility: 3-C Institute for Social Development
state: North Carolina
city: Durham
country: United States
facility: Duke Child and Family Study Center
state: North Carolina
Study officials:
affiliation: 3-C Institute for Social Development
name: Melissa E DeRosier, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: 3-C Institute for Social Development
name: Amanda W Harrell, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Allan K Chrisman, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: DeRosier ME. Building relationships and combating bullying: effectiveness of a school-based social skills group intervention. J Clin Child Adolesc Psychol. 2004 Mar;33(1):196-201. doi: 10.1207/S15374424JCCP3301_18.
citation: DeRosier ME, Marcus SR. Building friendships and combating bullying: effectiveness of S.S.GRIN at one-year follow-up. J Clin Child Adolesc Psychol. 2005 Mar;34(1):140-50. doi: 10.1207/s15374424jccp3401_13.
citation: DeRosier, M.E. & Gilliom, M. (2007). Effectiveness of a parent training program for improving children's social behavior. Journal of Child and Family Studies, 16, 660-670.
citation: DeRosier, M.E. (1995). Summary of 3-C Program Results with 3rd through 5th graders in the WCPSS.
citation: DeRosier, M.E. (2002). Group interventions and exercises for enhancing children's communication,cooperation, and confidence. Sarasota, FL: Professional Resources Press.
citation: DeRosier, M.E. (2006). Social Skills Group Intervention - Parent Guide(S.S.GRIN-PG). Cary, NC: SELmedia,Inc.